Eating DisorderNCT03796091
Efficacy Trial of a Dissonance Based Eating Disorder Program
A study testing Educational Brochure, Body Project Traditional and Body Project Expanded in people with Eating Disorder, run by Cornell College at 1 site in United States.
Trial summary
The purpose of this clinical trial is to investigate whether symptoms of disordered eating change among participants who complete an intervention. Participants will be randomly assigned to one of three intervention conditions and will undergo assessments of symptoms before, after, and 2 months after each intervention. Read more about this study
- Who is it for?
- Ages 15 to 34 years, women only
- Conditions the study is for
- Eating Disorder
- What is being tested?
- Educational Brochure, Body Project Traditional and Body Project Expanded
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2018to 15 Apr 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 34 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Women
- Age 15-34
- Postmenarcheal
- Premenopausal
- Subclinical or Clinical Eating Disorder Symptoms
Who cannot join
- Must get physician clearance to participate if at medically high risk as defined in the protocol
- Must not be pregnant
- Must be able to read and speak English
Trial locations and contacts
1 site in 1 country.
United States1 site
Cornell College Eating Disorder Institute
Mount Vernon, Iowa, 52314
About this study
The purpose of this clinical trial is to investigate whether symptoms of disordered eating change among participants who complete an intervention. Participants will be randomly assigned to one of three intervention conditions and will undergo assessments of symptoms before, after, and 2 months after each intervention. Investigators are evaluating which interventions are most effective in reducing eating disorder symptoms and disorder-related psychological and cardiac risk factors.
Read the detailed description
Assessment Sessions (Preintervention, Postintervention, 2-month follow-up): Participants in all conditions will participate in a series of 3 assessment sessions. Prior to each session, participants will complete online questions assessing eating disorder symptoms and associated psychological risk factors. This process will take approximately 40 minutes. Next participants will report to the laboratory at their scheduled appointment time to have their cardiac function assessed via blood pressure measurements and electrocardiography (EKG or ECG). Participants' height and weight will also be recorded.
Prior to each assessment session, participants should:
- Complete the online survey (if not completed prior to each laboratory appointment this will need to be completed at the lab appointment)
- Fast (not consume any food or beverages other than water) for at least 3 hours.
- Refrain from using nicotine for at least 3 hours.
- Refrain from vigorous physical exercise for at least 24 hours.
- Not show any symptoms of acute physical illness for 48 hours. It is important for participants to follow these directions so researchers can gather the most accurate data. If participants forget to follow these guidelines, or if an illness occurs, participants should contact their experimenter to reschedule.
On the day of an assessment session, participants will drive to the assessment location. Participants will receive directions via e-mail prior to each session. During the assessment session, participants will lie down on a laboratory cot for 10 minutes while preparation for electrocardiography (EKG or ECG) occurs. Electrodes will be applied to the chest and torso and lead wires will be attached to the electrodes. Participants' blood pressure will be assessed several times throughout this interval. Next, the experimenter will collect a 5 minute and 30 second recording of participants' cardiovascular data via electrocardiography (ECG or EKG). This data will later be analyzed to examine cardiac function.Next experimenters will assess participants' height and weight.
After each assessment session, participants' eating disorder symptoms, psychological risk factors, and cardiac indices will be evaluated by the research team. If the team determines that symptoms or cardiac indices are atypical and indicate a further need for evaluation, the participant will be contacted via both e-mail and phone to be informed results are atypical and the participant will be referred for further evaluation by a medical provider. If the participant is a minor, this information will be provided both to the participant and to the participant's parent and/or the participant's legal guardian. If participants' symptoms or risk factors worsen significantly over the duration of the trial, participants will also be contacted and provided with referral recommendations.
All participants will receive a comprehensive symptom report at the end of the trial. Referral resources will be provided again at that time if significant eating disorder symptoms remain.
Treatment Conditions: Participants will be randomly assigned to 1 of 3 treatment conditions.
Brochure Treatment Condition: Participants randomly assigned to the educational brochure will receive two educational brochures which discuss eating disorder symptoms. The brochures will also include treatment referral information and recommended resources for persons struggling with disordered eating. The brochure will take approximately 10 minutes to read; follow-up with treatment or self-help referral resources is completely voluntary.
Group Therapy Treatment Conditions: Participants randomly assigned to one of the two group treatment intervention conditions will complete a 4-week group treatment program with 3-8 other women and 2 trained treatment co-facilitators. For approximately 1 hour each week, participants will meet in this group to complete a series of readings, written activities, and verbal activities designed to reduce disordered eating. During the 4 intervention sessions, participants will be asked to analyze the weight and appearance-related messages received from the media, peers, family, romantic partners, and other sources. Participants will also be asked to record, analyze, and evaluate weight and appearance-related thoughts, emotions, and behaviors. Participants will engage in a variety of exercises designed to evaluate the meaning of thinness in our culture and its personal impact. These exercises are designed to combat the detrimental impact of messages which promote thinness.
Other risk factors will also be addressed, depending upon program. Participants may talk about the pressures women receive to focus on appearance. The relationship between these appearance-related pressures and eating disorder symptoms will be explored. Participants will explore the way they compare themselves to others and participate in a series of discussions and activities designed to decrease appearance-based comparisons with others.
After the 4-week program is complete, participants in both intervention conditions will continue to work on homework assignments related to the program for a period of 2-months until the final assessment session.
- Conditions
- Eating Disorder
- Being tested
- Educational Brochure, Body Project Traditional, Body Project Expanded
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational BrochureBehavioural
Participants will read an educational brochure from the National Eating Disorders Association and will receive treatment referral resources.
Body Project TraditionalBehavioural
Participants will complete a 1-hour per week group therapy program for 4 weeks consisting of the Body Project Traditional group therapy program (see Stice \& Shaw, 2001).
Body Project ExpandedBehavioural
Participants will complete a 1-hour per week group therapy program for 4 weeks consisting of the Body Project Expanded group therapy program (see Green et al., 2017).
| Study group | Role | What they receive |
|---|---|---|
| Educational Brochure | Active comparator | Participants will read an educational brochure from the National Eating Disorder Association and will receive referral resources. Receives: Behavioral: Educational Brochure |
| Body Project Traditional | Active comparator | Participants will complete group therapy for 1-hour per week for 4 weeks consisting of the Body Project group therapy program (Stice \& Shaw, 2001). Receives: Behavioral: Body Project Traditional |
| Body Project Expanded | Active comparator | Participants will complete group therapy for 1-hour per week for 4 weeks consisting of the Body Project Expanded group therapy program (Green et al., 2017). Receives: Behavioral: Body Project Expanded |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rosenberg Self-Esteem Scale (RSE).
The Rosenberg Self-Esteem Scale is designed to assess global feelings of self-worth. The RSE includes 10 items (e.g. "I feel that I'm a person of worth'') rated on a four-point scale (1 = strongly disagree, 4 = strongly agree). A total score represents the sum of individual item responses. Scores range from 10 to 40 and higher scores indicate higher levels of self-esteem.
Measured: Baseline assessments occurred after screening and prior to the delivery of any interventions.
Rosenberg Self-Esteem Scale (RSE).
The Rosenberg Self-Esteem Scale is designed to assess global feelings of self-worth. The RSE includes 10 items (e.g. "I feel that I'm a person of worth'') rated on a four-point scale (1 = strongly disagree, 4 = strongly agree). A total score represents the sum of individual item responses. Scores range from 10 to 40 and higher scores indicate higher levels of self-esteem.
Measured: Postintervention assessments were conducted approximately 4 weeks following the baseline assessment.
Rosenberg Self-Esteem Scale (RSE).
The Rosenberg Self-Esteem Scale is designed to assess global feelings of self-worth. The RSE includes 10 items (e.g. "I feel that I'm a person of worth'') rated on a four-point scale (1 = strongly disagree, 4 = strongly agree). A total score represents the sum of individual item responses. Scores range from 10 to 40 and higher scores indicate higher levels of self-esteem.
Measured: Follow-up assessments began approximately 8 weeks after the postintervention assessment.
Eating Disorder Examination Questionnaire (EDE-Q).
The 28-item Eating Disorder Examination Questionnaire global score was used to measure eating disorder symptomatology. Participants report symptomatology over the past 28 days on a 7-point Likert scale from 0 (no days) to 6 (everyday). The EDE-Q contains 4 subscales: Restraint, Weight Concern, Eating Concern, and Shape Concern. Subscale scores are calculated by finding the averages of the subscale items. A global score is also calculated by averaging the subscale scores. Scores range from 0 to 6; higher scores indicate higher levels of eating disorder pathology.
Measured: Baseline assessments occurred after screening and prior to the delivery of any interventions.
Eating Disorder Examination Questionnaire (EDE-Q).
The 28-item Eating Disorder Examination Questionnaire global score was used to measure eating disorder symptomatology. Participants report symptomatology over the past 28 days on a 7-point Likert scale from 0 (no days) to 6 (everyday). The EDE-Q contains 4 subscales: Restraint, Weight Concern, Eating Concern, and Shape Concern. Subscale scores are calculated by finding the averages of the subscale items. A global score is also calculated by averaging the subscale scores. Scores range from 0 to 6; higher scores indicate higher levels of eating disorder pathology.
Measured: Postintervention assessments were conducted approximately 4 weeks following the baseline assessment.
Eating Disorder Examination Questionnaire (EDE-Q).
The 28-item Eating Disorder Examination Questionnaire global score was used to measure eating disorder symptomatology. Participants report symptomatology over the past 28 days on a 7-point Likert scale from 0 (no days) to 6 (everyday). The EDE-Q contains 4 subscales: Restraint, Weight Concern, Eating Concern, and Shape Concern. Subscale scores are calculated by finding the averages of the subscale items. A global score is also calculated by averaging the subscale scores. Scores range from 0 to 6; higher scores indicate higher levels of eating disorder pathology.
Measured: Follow-up assessments began approximately 8 weeks after the postintervention assessment.
Body Shape Questionnaire (BSQ).
The Body Shape Questionnaire (BSQ) was used to measure body dissatisfaction in the present trial. The BSQ is a 34-item scale. Items are measured on a 6-point Likert scale designed to assess the frequency of negative body-related thoughts (1= never, 6 = always). Individual items are summed to compute an overall score. Scores on this scale range from 34 to 204. Higher scores indicate higher frequency of negative body-related thoughts and higher levels of body dissatisfaction.
Measured: Baseline assessments occurred after screening and prior to the delivery of any interventions.
Body Shape Questionnaire (BSQ).
The Body Shape Questionnaire (BSQ) was used to measure body dissatisfaction in the present trial. The BSQ is a 34-item scale. Items are measured on a 6-point Likert scale designed to assess the frequency of negative body-related thoughts (1= never, 6 = always). Individual items are summed to compute an overall score. Scores on this scale range from 34 to 204. Higher scores indicate higher frequency of negative body-related thoughts and higher levels of body dissatisfaction.
Measured: Postintervention assessments were conducted approximately 4 weeks following the baseline assessment.
Body Shape Questionnaire (BSQ).
The Body Shape Questionnaire (BSQ) was used to measure body dissatisfaction in the present trial. The BSQ is a 34-item scale. Items are measured on a 6-point Likert scale designed to assess the frequency of negative body-related thoughts (1= never, 6 = always). Individual items are summed to compute an overall score. Scores on this scale range from 34 to 204. Higher scores indicate higher frequency of negative body-related thoughts and higher levels of body dissatisfaction.
Measured: Follow-up assessments began approximately 8 weeks after the postintervention assessment.
Social Comparison Rating Scale (SCRS).
The Social Comparison Rating Scale (SCRS) is an 11-item scale used to assess perception of social rank and social comparison tendencies in the present trial. The scale consists of a series of bipolar adjectives (e.g., inferior/superior) separated by the numbers 1 through 10. For each adjective pair, participants are asked to rank themselves in comparison to others. A score around 60 indicates a person, on average, sees themselves approximately equal to others. Higher scores indicate higher levels of favorable social comparison and higher perceived social rank.
Measured: Baseline assessments occurred after screening and prior to the delivery of any interventions.
Social Comparison Rating Scale (SCRS).
The Social Comparison Rating Scale (SCRS) is an 11-item scale used to assess perception of social rank and social comparison tendencies in the present trial. The scale consists of a series of bipolar adjectives (e.g., inferior/superior) separated by the numbers 1 through 10. For each adjective pair, participants are asked to rank themselves in comparison to others. A score around 60 indicates a person, on average, sees themselves approximately equal to others. Higher scores indicate higher levels of favorable social comparison and higher perceived social rank.
Measured: Postintervention assessments were conducted approximately 4 weeks following the baseline assessment.
Social Comparison Rating Scale (SCRS).
The Social Comparison Rating Scale (SCRS) is an 11-item scale used to assess perception of social rank and social comparison tendencies in the present trial. The scale consists of a series of bipolar adjectives (e.g., inferior/superior) separated by the numbers 1 through 10. For each adjective pair, participants are asked to rank themselves in comparison to others. A score around 60 indicates a person, on average, sees themselves approximately equal to others. Higher scores indicate higher levels of favorable social comparison and higher perceived social rank.
Measured: Follow-up assessments began approximately 8 weeks after the postintervention assessment.
Self-Objectification Questionnaire (SOQ)
The Self-Objectification Questionnaire (SOQ) is a 10-item self-report inventory designed to assess the relative importance of body competence versus body appearance in sense of self. Participants rank appearance- versus competence-based attributes from 0 to 9 with higher scores representing higher importance. An overall trait self-objectification score is computed by summing competence and appearance ratings and subtracting the sum of competence ratings from the sum of appearance ratings. Resulting scores range from -25 to 25. Higher scores denote higher levels of trait self-objectification.
Measured: Baseline assessments occurred after screening and prior to the delivery of any interventions.
Self-Objectification Questionnaire (SOQ)
The Self-Objectification Questionnaire (SOQ) is a 10-item self-report inventory designed to assess the relative importance of body competence versus body appearance in sense of self. Participants rank appearance- versus competence-based attributes from 0 to 9 with higher scores representing higher importance. An overall trait self-objectification score is computed by summing competence and appearance ratings and subtracting the sum of competence ratings from the sum of appearance ratings. Resulting scores range from -25 to 25. Higher scores denote higher levels of trait self-objectification.
Measured: Postintervention assessments were conducted approximately 4 weeks following the baseline assessment.
Self-Objectification Questionnaire (SOQ)
The Self-Objectification Questionnaire (SOQ) is a 10-item self-report inventory designed to assess the relative importance of body competence versus body appearance in sense of self. Participants rank appearance- versus competence-based attributes from 0 to 9 with higher scores representing higher importance. An overall trait self-objectification score is computed by summing competence and appearance ratings and subtracting the sum of competence ratings from the sum of appearance ratings. Resulting scores range from -25 to 25. Higher scores denote higher levels of trait self-objectification.
Measured: Follow-up assessments began approximately 8 weeks after the postintervention assessment.
Ideal Body Stereotype Scale - Revised.
The Ideal Body Stereotype Scale - Revised was used to assess the extent to which participants internalized the cultural feminine thin-ideal. The IBSS-R is a self-report inventory which asks participants to report their level of agreement with 6 statements which indicate what attractive women look like on a 5-point scale ranging from strongly disagree (1) to strongly agree (5). Responses are averaged to compute a total score. Scores ranges from 1 to 5; higher scores indicate higher levels of thin-ideal internalization.
Measured: Baseline assessments occurred after screening and prior to the delivery of any interventions.
Ideal Body Stereotype Scale - Revised.
The Ideal Body Stereotype Scale - Revised was used to assess the extent to which participants internalized the cultural feminine thin-ideal. The IBSS-R is a self-report inventory which asks participants to report their level of agreement with 6 statements which indicate what attractive women look like on a 5-point scale ranging from strongly disagree (1) to strongly agree (5). Responses are averaged to compute a total score. Scores ranges from 1 to 5; higher scores indicate higher levels of thin-ideal internalization.
Measured: Postintervention assessments were conducted approximately 4 weeks following the baseline assessment.
Ideal Body Stereotype Scale - Revised.
The Ideal Body Stereotype Scale - Revised was used to assess the extent to which participants internalized the cultural feminine thin-ideal. The IBSS-R is a self-report inventory which asks participants to report their level of agreement with 6 statements which indicate what attractive women look like on a 5-point scale ranging from strongly disagree (1) to strongly agree (5). Responses are averaged to compute a total score. Scores ranges from 1 to 5; higher scores indicate higher levels of thin-ideal internalization.
Measured: Follow-up assessments began approximately 8 weeks after the postintervention assessment.
State Trait Anxiety Inventory - Form Y.
The State Trait Anxiety Inventory- Form Y (STAI) is a 20-item self-report measure used to assess level of trait anxiety in the present study. Each item consists of a statement which assesses feelings of anxiety or relaxation on a 4-point scale ranging from 1 (not at all) to 4 (very much so). Responses to individual items are summed to create an overall score. Scores range from 20 to 80. Higher scores indicate higher levels of anxiety.
Measured: Baseline assessments occurred after screening and prior to the delivery of any interventions.
State Trait Anxiety Inventory - Form Y.
The State Trait Anxiety Inventory- Form Y (STAI) is a 20-item self-report measure used to assess level of trait anxiety in the present study. Each item consists of a statement which assesses feelings of anxiety or relaxation on a 4-point scale ranging from 1 (not at all) to 4 (very much so). Responses to individual items are summed to create an overall score. Scores range from 20 to 80. Higher scores indicate higher levels of anxiety.
Measured: Postintervention assessments were conducted approximately 4 weeks following the baseline assessment.
State Trait Anxiety Inventory - Form Y.
The State Trait Anxiety Inventory- Form Y (STAI) is a 20-item self-report measure used to assess level of trait anxiety in the present study. Each item consists of a statement which assesses feelings of anxiety or relaxation on a 4-point scale ranging from 1 (not at all) to 4 (very much so). Responses to individual items are summed to create an overall score. Scores range from 20 to 80. Higher scores indicate higher levels of anxiety.
Measured: Follow-up assessments began approximately 8 weeks after the postintervention assessment.
Positive and Negative Affect Scale - Positive Affect
The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect.
Measured: Baseline assessments occurred after screening and prior to the delivery of any interventions.
Positive and Negative Affect Scale - Positive Affect
The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect.
Measured: Postintervention assessments were conducted approximately 4 weeks following the baseline assessment.
Positive and Negative Affect Scale - Positive Affect
The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect.
Measured: Follow-up assessments began approximately 8 weeks after the postintervention assessment.
Mean R Wave Amplitude
Mean R wave amplitude was determined via a 3-lead ECG and was measured in millivolts (mV). The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. A total of 5 minutes and 30 seconds of ECG data were collected to allow for artifact trimming. Artifacts were flagged by experimenters during data collection. Mean R wave amplitude represents ventricular depolarization. Higher magnitudes indicated increased polarity associated with an increased force of ventricular contraction.
Measured: Baseline assessments occurred after screening and prior to the delivery of any interventions.
Mean R Wave Amplitude
Mean R wave amplitude was determined via a 3-lead ECG and was measured in millivolts (mV). The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. A total of 5 minutes and 30 seconds of ECG data were collected to allow for artifact trimming. Artifacts were flagged by experimenters during data collection. Mean R wave amplitude represents ventricular depolarization and is measured in millivolts. Higher magnitudes indicated increased polarity associated with an increased force of ventricular contraction.
Measured: Postintervention assessments were conducted approximately 4 weeks following the baseline assessment.
Mean R Wave Amplitude
Mean R wave amplitude was determined via a 3-lead ECG and was measured in millivolts (mV). The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. A total of 5 minutes and 30 seconds of ECG data were collected to allow for artifact trimming. Artifacts were flagged by experimenters during data collection. Mean R wave amplitude represents ventricular depolarization and is measured in millivolts. Higher magnitudes indicated increased polarity associated with an increased force of ventricular contraction.
Measured: Follow-up assessments began approximately 8 weeks after the postintervention assessment.
QT Interval Length
QTc prolongation was measured in msec and was assessed via 3-lead ECG. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. For detection, typical QRS width was set at 80ms and R waves were at least 300ms apart. QTc was corrected with Bazett's formula. QT interval length represents the length of ventricular depolarization and repolarization and is measured in msec.
Measured: Baseline assessments occurred after screening and prior to the delivery of any interventions.
QT Interval Length
QTc prolongation was measured in msec and was assessed via 3-lead ECG. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. For detection, typical QRS width was set at 80ms and R waves were at least 300ms apart. QTc was corrected with Bazett's formula. QT interval length represents the length of ventricular depolarization and repolarization and is measured in msec.
Measured: Postintervention assessments were conducted approximately 4 weeks following the baseline assessment.
QT Interval Length
Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses.
Measured: Follow-up assessments began approximately 8 weeks after the postintervention assessment.
Vagal Cardiac Tone - High Frequency Spectral Power
High frequency spectral power was assessed via heart rate variability (HRV) power spectral analysis of 3-lead ECG data and was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. Maximum frequency was set at 0.5 Hz with number of frequencies at 500. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. Increased high frequency spectral power represents increased vagal input to the heart.
Measured: Baseline assessments occurred after screening and prior to the delivery of any interventions.
Vagal Cardiac Tone - High Frequency Spectral Power
High frequency spectral power was assessed via heart rate variability (HRV) power spectral analysis of 3-lead ECG data and was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. Maximum frequency was set at 0.5 Hz with number of frequencies at 500. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. Increased high frequency spectral power represents increased vagal input to the heart.
Measured: Postintervention assessments were conducted approximately 4 weeks following the baseline assessment.
Vagal Cardiac Tone - High Frequency Spectral Power
High frequency spectral power was assessed via heart rate variability (HRV) power spectral analysis of 3-lead ECG data and was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. Maximum frequency was set at 0.5 Hz with number of frequencies at 500. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. Increased high frequency spectral power represents increased vagal input to the heart.
Measured: Follow-up assessments began approximately 8 weeks after the postintervention assessment.
Sympathetic Cardiac Tone - Low Frequency High Frequency Spectral Power Ratio
Low frequency to high frequency spectral power was assessed via heart rate variability (HRV) power spectral analysis of 3-lead ECG. This index was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. Maximum frequency was set at 0.5 Hz with number of frequencies at 500. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. The ratio is designed to assess degree of sympathetic innervation to the heart.
Measured: Baseline assessments occurred after screening and prior to the delivery of any interventions.
Sympathetic Cardiac Tone - Low Frequency High Frequency Spectral Power Ratio
Low frequency to high frequency spectral power was assessed via heart rate variability (HRV) power spectral analysis of 3-lead ECG. This index was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. Maximum frequency was set at 0.5 Hz with number of frequencies at 500. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. The ratio is designed to assess degree of sympathetic innervation to the heart.
Measured: Postintervention assessments were conducted approximately 4 weeks following the baseline assessment.
Sympathetic Cardiac Tone - Low Frequency High Frequency Spectral Power Ratio
Low frequency to high frequency spectral power was assessed via heart rate variability (HRV) power spectral analysis of 3-lead ECG. This index was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. Maximum frequency was set at 0.5 Hz with number of frequencies at 500. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. The ratio is designed to assess degree of sympathetic innervation to the heart.
Measured: Follow-up assessments began approximately 8 weeks after the postintervention assessment.
Positive and Negative Affect Scale - Negative Affect
The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect.
Measured: Baseline assessments occurred after screening and prior to the delivery of any interventions.
Positive and Negative Affect Scale - Negative Affect
The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect.
Measured: Postintervention assessments were conducted approximately 4 weeks following the baseline assessment.
Positive and Negative Affect Scale - Negative Affect
The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect.
Measured: Follow-up assessments began approximately 8 weeks after the postintervention assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study start18 Nov 2018
- Primary completion15 Apr 2021
- Study completion15 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Eating DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled clinical trial with 3 treatment interventions
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cornell College
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Dr. Melinda Green, Cornell College
- Investigators
- Melinda A Green, PhD, Principal investigator, Green Counseling Services PLLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03796091
- Sponsor's protocol ID
- 1516-105-GRE
- Other IDs
- R15MH113044
- Status last verified
- Nov 2022
- First submitted
- 31 Dec 2018
- Last updated
- 9 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available to other researchers upon request and subject to signed confidentiality agreement.
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Trial of a Dissonance Based Eating Disorder Program
- ClinicalTrials.gov ID
- NCT03796091
- Acronym / sponsor ID
- 1516-105-GRE
- Conditions
- Eating Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Cornell CollegeUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 18 Nov 2018 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 15 Apr 2021 (actual)
- First posted
- 8 Jan 2019 (actual)
- Results
- Posted 9 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical trial is to investigate whether symptoms of disordered eating change among participants who complete an intervention. Participants will be randomly assigned to one of three intervention conditions and will undergo assessments of symptoms before, after, and 2 months after each intervention. Investigators are evaluating which interventions are most effective in reducing eating disorder symptoms and disorder-related psychological and cardiac risk factors.
Detailed description
Assessment Sessions (Preintervention, Postintervention, 2-month follow-up): Participants in all conditions will participate in a series of 3 assessment sessions. Prior to each session, participants will complete online questions assessing eating disorder symptoms and associated psychological risk factors. This process will take approximately 40 minutes. Next participants will report to the laboratory at their scheduled appointment time to have their cardiac function assessed via blood pressure measurements and electrocardiography (EKG or ECG). Participants' height and weight will also be recorded.
Prior to each assessment session, participants should:
- Complete the online survey (if not completed prior to each laboratory appointment this will need to be completed at the lab appointment)
- Fast (not consume any food or beverages other than water) for at least 3 hours.
- Refrain from using nicotine for at least 3 hours.
- Refrain from vigorous physical exercise for at least 24 hours.
- Not show any symptoms of acute physical illness for 48 hours. It is important for participants to follow these directions so researchers can gather the most accurate data. If participants forget to follow these guidelines, or if an illness occurs, participants should contact their experimenter to reschedule.
On the day of an assessment session, participants will drive to the assessment location. Participants will receive directions via e-mail prior to each session. During the assessment session, participants will lie down on a laboratory cot for 10 minutes while preparation for electrocardiography (EKG or ECG) occurs. Electrodes will be applied to the chest and torso and lead wires will be attached to the electrodes. Participants' blood pressure will be assessed several times throughout this interval. Next, the experimenter will collect a 5 minute and 30 second recording of participants' cardiovascular data via electrocardiography (ECG or EKG). This data will later be analyzed to examine cardiac function.Next experimenters will assess participants' height and weight.
After each assessment session, participants' eating disorder symptoms, psychological risk factors, and cardiac indices will be evaluated by the research team. If the team determines that symptoms or cardiac indices are atypical and indicate a further need for evaluation, the participant will be contacted via both e-mail and phone to be informed results are atypical and the participant will be referred for further evaluation by a medical provider. If the participant is a minor, this information will be provided both to the participant and to the participant's parent and/or the participant's legal guardian. If participants' symptoms or risk factors worsen significantly over the duration of the trial, participants will also be contacted and provided with referral recommendations.
All participants will receive a comprehensive symptom report at the end of the trial. Referral resources will be provided again at that time if significant eating disorder symptoms remain.
Treatment Conditions: Participants will be randomly assigned to 1 of 3 treatment conditions.
Brochure Treatment Condition: Participants randomly assigned to the educational brochure will receive two educational brochures which discuss eating disorder symptoms. The brochures will also include treatment referral information and recommended resources for persons struggling with disordered eating. The brochure will take approximately 10 minutes to read; follow-up with treatment or self-help referral resources is completely voluntary.
Group Therapy Treatment Conditions: Participants randomly assigned to one of the two group treatment intervention conditions will complete a 4-week group treatment program with 3-8 other women and 2 trained treatment co-facilitators. For approximately 1 hour each week, participants will meet in this group to complete a series of readings, written activities, and verbal activities designed to reduce disordered eating. During the 4 intervention sessions, participants will be asked to analyze the weight and appearance-related messages received from the media, peers, family, romantic partners, and other sources. Participants will also be asked to record, analyze, and evaluate weight and appearance-related thoughts, emotions, and behaviors. Participants will engage in a variety of exercises designed to evaluate the meaning of thinness in our culture and its personal impact. These exercises are designed to combat the detrimental impact of messages which promote thinness.
Other risk factors will also be addressed, depending upon program. Participants may talk about the pressures women receive to focus on appearance. The relationship between these appearance-related pressures and eating disorder symptoms will be explored. Participants will explore the way they compare themselves to others and participate in a series of discussions and activities designed to decrease appearance-based comparisons with others.
After the 4-week program is complete, participants in both intervention conditions will continue to work on homework assignments related to the program for a period of 2-months until the final assessment session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized, controlled clinical trial with 3 treatment interventions
| Arm | Type | Receives |
|---|---|---|
| Educational Brochure | Active comparator | Behavioral: Educational BrochureParticipants will read an educational brochure from the National Eating Disorder Association and will receive referral resources. |
| Body Project Traditional | Active comparator | Behavioral: Body Project TraditionalParticipants will complete group therapy for 1-hour per week for 4 weeks consisting of the Body Project group therapy program (Stice \& Shaw, 2001). |
| Body Project Expanded | Active comparator | Behavioral: Body Project ExpandedParticipants will complete group therapy for 1-hour per week for 4 weeks consisting of the Body Project Expanded group therapy program (Green et al., 2017). |
Who may qualify
- Ages
- 15 to 34 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
Key exclusion criteria (3 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational BrochureParticipants will read an educational brochure from the National Eating Disorders Association and will receive treatment referral resources. | Behavioural | Educational Brochure |
| Body Project TraditionalParticipants will complete a 1-hour per week group therapy program for 4 weeks consisting of the Body Project Traditional group therapy program (see Stice \& Shaw, 2001). | Behavioural | Body Project Traditional |
| Body Project ExpandedParticipants will complete a 1-hour per week group therapy program for 4 weeks consisting of the Body Project Expanded group therapy program (see Green et al., 2017). | Behavioural | Body Project Expanded |
Primary outcome
Rosenberg Self-Esteem Scale (RSE).
Time frame: Baseline assessments occurred after screening and prior to the delivery of any interventions.
The Rosenberg Self-Esteem Scale is designed to assess global feelings of self-worth. The RSE includes 10 items (e.g. "I feel that I'm a person of worth'') rated on a four-point scale (1 = strongly disagree, 4 = strongly agree). A total score represents the sum of individual item responses. Scores range from 10 to 40 and higher scores indicate higher levels of self-esteem.
Rosenberg Self-Esteem Scale (RSE).
Time frame: Postintervention assessments were conducted approximately 4 weeks following the baseline assessment.
The Rosenberg Self-Esteem Scale is designed to assess global feelings of self-worth. The RSE includes 10 items (e.g. "I feel that I'm a person of worth'') rated on a four-point scale (1 = strongly disagree, 4 = strongly agree). A total score represents the sum of individual item responses. Scores range from 10 to 40 and higher scores indicate higher levels of self-esteem.
Rosenberg Self-Esteem Scale (RSE).
Time frame: Follow-up assessments began approximately 8 weeks after the postintervention assessment.
The Rosenberg Self-Esteem Scale is designed to assess global feelings of self-worth. The RSE includes 10 items (e.g. "I feel that I'm a person of worth'') rated on a four-point scale (1 = strongly disagree, 4 = strongly agree). A total score represents the sum of individual item responses. Scores range from 10 to 40 and higher scores indicate higher levels of self-esteem.
Eating Disorder Examination Questionnaire (EDE-Q).
Time frame: Baseline assessments occurred after screening and prior to the delivery of any interventions.
The 28-item Eating Disorder Examination Questionnaire global score was used to measure eating disorder symptomatology. Participants report symptomatology over the past 28 days on a 7-point Likert scale from 0 (no days) to 6 (everyday). The EDE-Q contains 4 subscales: Restraint, Weight Concern, Eating Concern, and Shape Concern. Subscale scores are calculated by finding the averages of the subscale items. A global score is also calculated by averaging the subscale scores. Scores range from 0 to 6; higher scores indicate higher levels of eating disorder pathology.
Eating Disorder Examination Questionnaire (EDE-Q).
Time frame: Postintervention assessments were conducted approximately 4 weeks following the baseline assessment.
The 28-item Eating Disorder Examination Questionnaire global score was used to measure eating disorder symptomatology. Participants report symptomatology over the past 28 days on a 7-point Likert scale from 0 (no days) to 6 (everyday). The EDE-Q contains 4 subscales: Restraint, Weight Concern, Eating Concern, and Shape Concern. Subscale scores are calculated by finding the averages of the subscale items. A global score is also calculated by averaging the subscale scores. Scores range from 0 to 6; higher scores indicate higher levels of eating disorder pathology.
Eating Disorder Examination Questionnaire (EDE-Q).
Time frame: Follow-up assessments began approximately 8 weeks after the postintervention assessment.
The 28-item Eating Disorder Examination Questionnaire global score was used to measure eating disorder symptomatology. Participants report symptomatology over the past 28 days on a 7-point Likert scale from 0 (no days) to 6 (everyday). The EDE-Q contains 4 subscales: Restraint, Weight Concern, Eating Concern, and Shape Concern. Subscale scores are calculated by finding the averages of the subscale items. A global score is also calculated by averaging the subscale scores. Scores range from 0 to 6; higher scores indicate higher levels of eating disorder pathology.
Body Shape Questionnaire (BSQ).
Time frame: Baseline assessments occurred after screening and prior to the delivery of any interventions.
The Body Shape Questionnaire (BSQ) was used to measure body dissatisfaction in the present trial. The BSQ is a 34-item scale. Items are measured on a 6-point Likert scale designed to assess the frequency of negative body-related thoughts (1= never, 6 = always). Individual items are summed to compute an overall score. Scores on this scale range from 34 to 204. Higher scores indicate higher frequency of negative body-related thoughts and higher levels of body dissatisfaction.
Body Shape Questionnaire (BSQ).
Time frame: Postintervention assessments were conducted approximately 4 weeks following the baseline assessment.
The Body Shape Questionnaire (BSQ) was used to measure body dissatisfaction in the present trial. The BSQ is a 34-item scale. Items are measured on a 6-point Likert scale designed to assess the frequency of negative body-related thoughts (1= never, 6 = always). Individual items are summed to compute an overall score. Scores on this scale range from 34 to 204. Higher scores indicate higher frequency of negative body-related thoughts and higher levels of body dissatisfaction.
Body Shape Questionnaire (BSQ).
Time frame: Follow-up assessments began approximately 8 weeks after the postintervention assessment.
The Body Shape Questionnaire (BSQ) was used to measure body dissatisfaction in the present trial. The BSQ is a 34-item scale. Items are measured on a 6-point Likert scale designed to assess the frequency of negative body-related thoughts (1= never, 6 = always). Individual items are summed to compute an overall score. Scores on this scale range from 34 to 204. Higher scores indicate higher frequency of negative body-related thoughts and higher levels of body dissatisfaction.
Social Comparison Rating Scale (SCRS).
Time frame: Baseline assessments occurred after screening and prior to the delivery of any interventions.
The Social Comparison Rating Scale (SCRS) is an 11-item scale used to assess perception of social rank and social comparison tendencies in the present trial. The scale consists of a series of bipolar adjectives (e.g., inferior/superior) separated by the numbers 1 through 10. For each adjective pair, participants are asked to rank themselves in comparison to others. A score around 60 indicates a person, on average, sees themselves approximately equal to others. Higher scores indicate higher levels of favorable social comparison and higher perceived social rank.
Social Comparison Rating Scale (SCRS).
Time frame: Postintervention assessments were conducted approximately 4 weeks following the baseline assessment.
The Social Comparison Rating Scale (SCRS) is an 11-item scale used to assess perception of social rank and social comparison tendencies in the present trial. The scale consists of a series of bipolar adjectives (e.g., inferior/superior) separated by the numbers 1 through 10. For each adjective pair, participants are asked to rank themselves in comparison to others. A score around 60 indicates a person, on average, sees themselves approximately equal to others. Higher scores indicate higher levels of favorable social comparison and higher perceived social rank.
Social Comparison Rating Scale (SCRS).
Time frame: Follow-up assessments began approximately 8 weeks after the postintervention assessment.
The Social Comparison Rating Scale (SCRS) is an 11-item scale used to assess perception of social rank and social comparison tendencies in the present trial. The scale consists of a series of bipolar adjectives (e.g., inferior/superior) separated by the numbers 1 through 10. For each adjective pair, participants are asked to rank themselves in comparison to others. A score around 60 indicates a person, on average, sees themselves approximately equal to others. Higher scores indicate higher levels of favorable social comparison and higher perceived social rank.
Self-Objectification Questionnaire (SOQ)
Time frame: Baseline assessments occurred after screening and prior to the delivery of any interventions.
The Self-Objectification Questionnaire (SOQ) is a 10-item self-report inventory designed to assess the relative importance of body competence versus body appearance in sense of self. Participants rank appearance- versus competence-based attributes from 0 to 9 with higher scores representing higher importance. An overall trait self-objectification score is computed by summing competence and appearance ratings and subtracting the sum of competence ratings from the sum of appearance ratings. Resulting scores range from -25 to 25. Higher scores denote higher levels of trait self-objectification.
Self-Objectification Questionnaire (SOQ)
Time frame: Postintervention assessments were conducted approximately 4 weeks following the baseline assessment.
The Self-Objectification Questionnaire (SOQ) is a 10-item self-report inventory designed to assess the relative importance of body competence versus body appearance in sense of self. Participants rank appearance- versus competence-based attributes from 0 to 9 with higher scores representing higher importance. An overall trait self-objectification score is computed by summing competence and appearance ratings and subtracting the sum of competence ratings from the sum of appearance ratings. Resulting scores range from -25 to 25. Higher scores denote higher levels of trait self-objectification.
Self-Objectification Questionnaire (SOQ)
Time frame: Follow-up assessments began approximately 8 weeks after the postintervention assessment.
The Self-Objectification Questionnaire (SOQ) is a 10-item self-report inventory designed to assess the relative importance of body competence versus body appearance in sense of self. Participants rank appearance- versus competence-based attributes from 0 to 9 with higher scores representing higher importance. An overall trait self-objectification score is computed by summing competence and appearance ratings and subtracting the sum of competence ratings from the sum of appearance ratings. Resulting scores range from -25 to 25. Higher scores denote higher levels of trait self-objectification.
Ideal Body Stereotype Scale - Revised.
Time frame: Baseline assessments occurred after screening and prior to the delivery of any interventions.
The Ideal Body Stereotype Scale - Revised was used to assess the extent to which participants internalized the cultural feminine thin-ideal. The IBSS-R is a self-report inventory which asks participants to report their level of agreement with 6 statements which indicate what attractive women look like on a 5-point scale ranging from strongly disagree (1) to strongly agree (5). Responses are averaged to compute a total score. Scores ranges from 1 to 5; higher scores indicate higher levels of thin-ideal internalization.
Ideal Body Stereotype Scale - Revised.
Time frame: Postintervention assessments were conducted approximately 4 weeks following the baseline assessment.
The Ideal Body Stereotype Scale - Revised was used to assess the extent to which participants internalized the cultural feminine thin-ideal. The IBSS-R is a self-report inventory which asks participants to report their level of agreement with 6 statements which indicate what attractive women look like on a 5-point scale ranging from strongly disagree (1) to strongly agree (5). Responses are averaged to compute a total score. Scores ranges from 1 to 5; higher scores indicate higher levels of thin-ideal internalization.
Ideal Body Stereotype Scale - Revised.
Time frame: Follow-up assessments began approximately 8 weeks after the postintervention assessment.
The Ideal Body Stereotype Scale - Revised was used to assess the extent to which participants internalized the cultural feminine thin-ideal. The IBSS-R is a self-report inventory which asks participants to report their level of agreement with 6 statements which indicate what attractive women look like on a 5-point scale ranging from strongly disagree (1) to strongly agree (5). Responses are averaged to compute a total score. Scores ranges from 1 to 5; higher scores indicate higher levels of thin-ideal internalization.
State Trait Anxiety Inventory - Form Y.
Time frame: Baseline assessments occurred after screening and prior to the delivery of any interventions.
The State Trait Anxiety Inventory- Form Y (STAI) is a 20-item self-report measure used to assess level of trait anxiety in the present study. Each item consists of a statement which assesses feelings of anxiety or relaxation on a 4-point scale ranging from 1 (not at all) to 4 (very much so). Responses to individual items are summed to create an overall score. Scores range from 20 to 80. Higher scores indicate higher levels of anxiety.
State Trait Anxiety Inventory - Form Y.
Time frame: Postintervention assessments were conducted approximately 4 weeks following the baseline assessment.
The State Trait Anxiety Inventory- Form Y (STAI) is a 20-item self-report measure used to assess level of trait anxiety in the present study. Each item consists of a statement which assesses feelings of anxiety or relaxation on a 4-point scale ranging from 1 (not at all) to 4 (very much so). Responses to individual items are summed to create an overall score. Scores range from 20 to 80. Higher scores indicate higher levels of anxiety.
State Trait Anxiety Inventory - Form Y.
Time frame: Follow-up assessments began approximately 8 weeks after the postintervention assessment.
The State Trait Anxiety Inventory- Form Y (STAI) is a 20-item self-report measure used to assess level of trait anxiety in the present study. Each item consists of a statement which assesses feelings of anxiety or relaxation on a 4-point scale ranging from 1 (not at all) to 4 (very much so). Responses to individual items are summed to create an overall score. Scores range from 20 to 80. Higher scores indicate higher levels of anxiety.
Positive and Negative Affect Scale - Positive Affect
Time frame: Baseline assessments occurred after screening and prior to the delivery of any interventions.
The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect.
Positive and Negative Affect Scale - Positive Affect
Time frame: Postintervention assessments were conducted approximately 4 weeks following the baseline assessment.
The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect.
Positive and Negative Affect Scale - Positive Affect
Time frame: Follow-up assessments began approximately 8 weeks after the postintervention assessment.
The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect.
Mean R Wave Amplitude
Time frame: Baseline assessments occurred after screening and prior to the delivery of any interventions.
Mean R wave amplitude was determined via a 3-lead ECG and was measured in millivolts (mV). The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. A total of 5 minutes and 30 seconds of ECG data were collected to allow for artifact trimming. Artifacts were flagged by experimenters during data collection. Mean R wave amplitude represents ventricular depolarization. Higher magnitudes indicated increased polarity associated with an increased force of ventricular contraction.
Mean R Wave Amplitude
Time frame: Postintervention assessments were conducted approximately 4 weeks following the baseline assessment.
Mean R wave amplitude was determined via a 3-lead ECG and was measured in millivolts (mV). The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. A total of 5 minutes and 30 seconds of ECG data were collected to allow for artifact trimming. Artifacts were flagged by experimenters during data collection. Mean R wave amplitude represents ventricular depolarization and is measured in millivolts. Higher magnitudes indicated increased polarity associated with an increased force of ventricular contraction.
Mean R Wave Amplitude
Time frame: Follow-up assessments began approximately 8 weeks after the postintervention assessment.
Mean R wave amplitude was determined via a 3-lead ECG and was measured in millivolts (mV). The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. A total of 5 minutes and 30 seconds of ECG data were collected to allow for artifact trimming. Artifacts were flagged by experimenters during data collection. Mean R wave amplitude represents ventricular depolarization and is measured in millivolts. Higher magnitudes indicated increased polarity associated with an increased force of ventricular contraction.
QT Interval Length
Time frame: Baseline assessments occurred after screening and prior to the delivery of any interventions.
QTc prolongation was measured in msec and was assessed via 3-lead ECG. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. For detection, typical QRS width was set at 80ms and R waves were at least 300ms apart. QTc was corrected with Bazett's formula. QT interval length represents the length of ventricular depolarization and repolarization and is measured in msec.
QT Interval Length
Time frame: Postintervention assessments were conducted approximately 4 weeks following the baseline assessment.
QTc prolongation was measured in msec and was assessed via 3-lead ECG. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. For detection, typical QRS width was set at 80ms and R waves were at least 300ms apart. QTc was corrected with Bazett's formula. QT interval length represents the length of ventricular depolarization and repolarization and is measured in msec.
QT Interval Length
Time frame: Follow-up assessments began approximately 8 weeks after the postintervention assessment.
Mean scores and standard deviations were reported as a function of group and time. Single mean imputation was used to impute all missing scores to reflect a sample size of n=60 per condition (N=180 total) based on participants admitted at the beginning of the trial. The outcome analyses were based on imputed values and therefore, overall number of participants analyzed equals 60 per condition in the outcome analyses.
Vagal Cardiac Tone - High Frequency Spectral Power
Time frame: Baseline assessments occurred after screening and prior to the delivery of any interventions.
High frequency spectral power was assessed via heart rate variability (HRV) power spectral analysis of 3-lead ECG data and was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. Maximum frequency was set at 0.5 Hz with number of frequencies at 500. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. Increased high frequency spectral power represents increased vagal input to the heart.
Vagal Cardiac Tone - High Frequency Spectral Power
Time frame: Postintervention assessments were conducted approximately 4 weeks following the baseline assessment.
High frequency spectral power was assessed via heart rate variability (HRV) power spectral analysis of 3-lead ECG data and was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. Maximum frequency was set at 0.5 Hz with number of frequencies at 500. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. Increased high frequency spectral power represents increased vagal input to the heart.
Vagal Cardiac Tone - High Frequency Spectral Power
Time frame: Follow-up assessments began approximately 8 weeks after the postintervention assessment.
High frequency spectral power was assessed via heart rate variability (HRV) power spectral analysis of 3-lead ECG data and was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. ECG data were analyzed via PowerLab LabChart 8 software. Maximum frequency was set at 0.5 Hz with number of frequencies at 500. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. Increased high frequency spectral power represents increased vagal input to the heart.
Sympathetic Cardiac Tone - Low Frequency High Frequency Spectral Power Ratio
Time frame: Baseline assessments occurred after screening and prior to the delivery of any interventions.
Low frequency to high frequency spectral power was assessed via heart rate variability (HRV) power spectral analysis of 3-lead ECG. This index was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. Maximum frequency was set at 0.5 Hz with number of frequencies at 500. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. The ratio is designed to assess degree of sympathetic innervation to the heart.
Sympathetic Cardiac Tone - Low Frequency High Frequency Spectral Power Ratio
Time frame: Postintervention assessments were conducted approximately 4 weeks following the baseline assessment.
Low frequency to high frequency spectral power was assessed via heart rate variability (HRV) power spectral analysis of 3-lead ECG. This index was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. Maximum frequency was set at 0.5 Hz with number of frequencies at 500. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. The ratio is designed to assess degree of sympathetic innervation to the heart.
Sympathetic Cardiac Tone - Low Frequency High Frequency Spectral Power Ratio
Time frame: Follow-up assessments began approximately 8 weeks after the postintervention assessment.
Low frequency to high frequency spectral power was assessed via heart rate variability (HRV) power spectral analysis of 3-lead ECG. This index was reported in normalized units. The ECG signal was acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup included an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. Maximum frequency was set at 0.5 Hz with number of frequencies at 500. LF spectral power ranged from 0.04-0.15 Hz. HF spectral power ranged from 0.15-0.45 Hz. The ratio is designed to assess degree of sympathetic innervation to the heart.
Positive and Negative Affect Scale - Negative Affect
Time frame: Baseline assessments occurred after screening and prior to the delivery of any interventions.
The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect.
Positive and Negative Affect Scale - Negative Affect
Time frame: Postintervention assessments were conducted approximately 4 weeks following the baseline assessment.
The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect.
Positive and Negative Affect Scale - Negative Affect
Time frame: Follow-up assessments began approximately 8 weeks after the postintervention assessment.
The Positive and Negative Affect Schedule is a 20-item self-report questionnaire that used to measure positive and negative affect. Items are rated on a 5-point scale ranging from 1 (very slightly) to 5 (extremely) which measures the extent to which the client has experienced that affect over the past week. The 10 positive and 10 negative items are summed separately to create a positive affect score and a negative affect score respectively. Each score ranges between 0 and 50 with higher scores indicating higher positive or negative affect.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Data will be made available to other researchers upon request and subject to signed confidentiality agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melinda A Green, PhD principal investigator
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1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Brochure, Body Project Traditional and Body Project Expanded in people with Eating Disorder, run by Cornell College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rosenberg Self-Esteem Scale (RSE). (time frame: Baseline assessments occurred after screening and prior to the delivery of any interventions.). The study lists 39 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2022.