Eating Disorder SymptomNCT03040076
Testing if Reductions in Negative Affect Yield Decreased Emotional Eating Symptoms
A study testing Cognitive Bias Treatment and Relaxation Condition in people with Eating Disorder Symptom and Emotional Maladjustment, run by Florida State University at 1 site in United States.
Trial summary
The purpose of this study to test a computerized treatment designed to help people with high levels of emotional eating, which is when people eat to cope with negative emotions and/or stressful situations. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Eating Disorder Symptom, Emotional Maladjustment, Negative Thoughts
- What is being tested?
- Cognitive Bias Treatment and Relaxation Condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2017to 3 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female between the ages of 18 and 45 years of age
- An emotional eating score more than one SD above the mean (>2.9) on the Dutch Eating Behavior Questionnaire (DEBQ) emotional eating scale (van Strien, Frijters, Bergers, \& Defares, 1986).
- Regular computer and internet access
- Rate liking of vanilla frozen yogurt as a 6 or higher on a 10 point scale.
Who cannot join
- Body mass index (BMI; kg/m2) less than 18.5 (World Health Organization, 2000), given known cognitive impairments that can result from being underweight (Fowler et al., 2006).
- Current psychotic, manic, or substance use disorders, as these may interfere with their ability to cognitively engage in the intervention.
- Food allergies that would prevent consumption of vanilla frozen yogurt.
Trial locations and contacts
1 site in 1 country.
United States1 site
Eating Behaviors Research Clinic, Department of Psychology, Florida State University
Tallahassee, Florida, 32308
About this study
Official title: Testing if Reductions in Negative Affect Yield Decreased Emotional Eating Symptoms: A Cognitive Bias Intervention
The purpose of this study to test a computerized treatment designed to help people with high levels of emotional eating, which is when people eat to cope with negative emotions and/or stressful situations. The investigators are interested in comparing two different ways of coping with negative emotions, relaxation training or training in how to think differently about such situations. Additionally, the researchers' study seeks to understand more about the psychological factors that may contribute to someone having difficulty with emotional eating.
Read the detailed description
Emotional eating, or eating as a mechanism for coping with negative affect, is present across a spectrum of eating disorders and is associated with poor health outcomes, namely obesity. Research suggests that individuals with emotional eating experience urges to eat in response to multiple negative emotions, including anxiety, depression, and anger. While emotional eating is related to binge eating, it can be examined in a more dimensional fashion because it is not associated with a specific size criterion or a requirement of loss of control over eating. As such, emotional eating is a useful analog through which to understand mechanisms of binge eating and test the preliminary efficacy of treatment interventions. Interventions that target mechanisms of regulating negative affect may reduce both negative affect and emotional eating, increasing their transdiagnostic value. Research suggests that a large gap exists between the prevalence of psychopathology and access to psychological treatment, and this gap extends to individuals with eating disorders. A potential solution to these challenges is the use of computerized methodologies that may be easier to disseminate, allow for a gradient of treatment intensity, and do not rely upon training treatment providers. Computer-administered CBM interventions address the need for more easily disseminated treatments. CBM interventions are based in research suggesting that negative interpretation biases cause negative emotionality and subsequent symptom expression. Negative interpretation biases are the tendency to draw threatening conclusions about ambiguous information. Thus, CBM paradigms train people to make neutral or positive attributions about situations they would typically view through the lens of their negative biases. CBM interventions have been tested across a range of psychopathology, including anxiety disorders, depression, and anger, and using a variety of different bias modification techniques. Two recent CBM studies have been tested within the field of eating disorders. Although results were promising, both studies were marked by methodological limitations and neither addressed emotional eating specifically. The purpose of the present study is to test a CBM intervention designed to help individuals with elevated emotional eating improve their ability to regulate negative affect. In doing so, the investigators will determine if modifying the interpretation of ambiguous situations that would typically result in negative affect can reduce negative affect in individuals with high emotional eating. The researchers will in turn determine if those individuals have decreased food consumption under conditions that would otherwise elicit negative emotions. This project extends initial research on CBMs in eating disorders, as well as research suggesting that basic emotion regulation training can decrease emotional eating.
- Being tested
- Cognitive Bias Treatment, Relaxation Condition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Bias TreatmentBehavioural
Two computerized tasks will be administered during four intervention sessions. During the first task, the Word Sentence Association Paradigm, participants see a threat or benign word and then an ambiguous sentence. Participants press one if they believe the word and sentence are related and two if they believe the word and sentence are not related. Participants are given feedback that they responded correctly if they state that a benign word is related to the sentence or they state that a threat word is not related to the sentence. The second task is the Ambiguous Scenarios Task. In each trial, an ambiguous scenario, ending in a benign word, appears on the screen. After the scenario is presented, participants respond to a comprehension question and are given feedback on their performance.
Relaxation ConditionBehavioural
Participants assigned to the active control group will complete four sessions of progressive muscle relaxation training. Two alternating relaxation scripts will be used. The scripts will be presented as Youtube videos with a blank black screen and will instruct participants to keep their eyes closed for the duration of the training. Participants will access the videos through Qualtrics to ensure that data can be gathered about their compliance. The relaxation scripts used in the present study will be modified versions of those currently being tested by other researchers utilizing cognitive bias modification paradigms. The relaxation training sessions will be matched to the length of the treatment condition and therefore will last approximately 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Bias Treatment | Experimental | Intervention condition Receives: Behavioral: Cognitive Bias Treatment |
| Relaxation Condition | Active comparator | Active control condition Receives: Behavioral: Relaxation Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Emotional Overeating Questionnaire Scores
Emotional eating will be measured using the 6-item Emotional Overeating Questionnaire (EOQ; Masheb \& Grilo, 2006), in which participants report on the frequency of eating in response to five negative emotions and one positive emotion. The instructions and item scaling will be modified to decrease the timeframe assessed from 28 days to 5 days, in order to be sensitive to changes during the present intervention. Each item will be assessed on a 5-point scale (0= no days to 5 = every day). Further, the instructions will be modified to not specifically reference eating an objectively large amount of food. This change is made in order to ensure consistency with how emotional eating is conceptualized in the literature (i.e., no specific size criterion). Change in scores at each of the time points will be used to determine symptom improvement.
Measured: Assessed at baseline (time zero), mid-treatment (8 days after baseline), and post-treatment (2 weeks after baseline).
Change in Positive and Negative Affect Schedule Scores
Negative affect will be assessed using the negative affect scale of the Positive and Negative Affect Schedule (PANAS; Watson, Clark, \& Tellegen, 1988), which is a 10-item measure of negative emotions on a scale of 1 ("very slightly or not at all) to 5 ("extremely"). The instructions can be modified as needed to reflect the desired timeframe of assessment (Watson et al., 1988) and therefore, we will instruct participants to consider the past five days.Change in scores at each of the time points will be used to determine symptom improvement.
Measured: Assessed at baseline (time zero), mid-treatment (8 days after baseline), and post-treatment (2 weeks after baseline).
Change in Word Sentence Association Paradigm Scores
A modified version of the treatment condition Word Sentence Association Paradigm (WSAP; Amir \& Taylor, 2012b; Beard \& Amir, 2008; Hindash \& Amir, 2012) will be used to assess interpretation bias. The ambiguous sentences will be distinct from those used in the bias modification program in order to allow for a more generalized assessment of change in biases. However, to permit an accurate assessment of changes in bias, the WSAP task will be the same at pre-, mid and post treatment. Scores on the WSAP task are calculated as the ratio of percent threatening to percent benign interpretations across the trials. Change in scores at each of the time points will be used to determine symptom improvement.
Measured: Assessed at baseline (time zero), mid-treatment (8 days after baseline), and post-treatment (2 weeks after baseline).
Secondary outcomes (7)
Body Mass Index
Body mass index (BMI) will be computed using participants' height, measured with a wall-mounted ruler, and weight, measured with an electronic scale.
Measured: Assessed at baseline (time zero).
Eating Pathology Symptoms Inventory
Eating disorder symptoms will be measured using the 8-item binge eating subscale of the Eating Pathology Symptoms Inventory (EPSI; Forbush et al., 2013), which measures features of binge eating (e.g., consumption of large quantities of food, mindless eating) on a 5-point Likert scale from "never" to "very often." The EPSI scale is designed to assess behavior over the past 28 days (Forbush et al., 2013); however, to be sensitive to the timeframe of the present study, the instructions will be modified to ask participants to consider the past week.
Measured: Assessed at baseline (time zero) and post-treatment (2 weeks after baseline).
Depression and Anxiety Stress Scale
Depression, anxiety, and stress symptoms will be measured using the Depression and Anxiety Stress Scale (DASS; Lovibond \& Lovibond, 1995a). The DASS is a 42-item measure that assesses such symptoms over the preceding week on a 0 to 3 scale from "did not apply to me at all" to "applied to me very much, or most of the time."
Measured: Assessed at baseline (time zero) and post-treatment (2 weeks after baseline).
State-Trait Anger Expression Inventory, Second Edition
Anger symptoms will be measured using the trait anger scale of the State-Trait Anger Expression Inventory, Second Edition (STAXI-2; Spielberger, 1999). Only the trait scale will be used in the present study given our interest in assessing overall anger symptoms, not momentary anger levels, as a moderating variable. The trait scale consists of 10 items that assess frequency of anger a 4-point scale from "almost never" to "almost always," but is not measured across a specific timeframe (Spielberger \& Reheiser, 2009).
Measured: Assessed at baseline (time zero) and post-treatment (2 weeks after baseline).
Difficulties in Emotion Regulation Scale
Emotion dysregulation will be assessed using the Difficulties in Emotion Regulation Scale (DERS; Gratz \& Roemer, 2004). The DERS is a 36-item measure of six aspects of emotion dysregulation; all items are measured on a 1 ("almost never") to 5 ("almost always") scale and are not anchored to a specific timeframe.
Measured: Assessed at baseline (time zero) and post-treatment (2 weeks after baseline).
Visual Analogue Scale Ratings
Before, during, and after a behavioral task designed to measure food consumption following stress, participants will complete Visual Analogue Scale (VAS; Rolls et al., 1992) ratings of hunger and fullness, as well as state affect (e.g., sad, anxious, frustrated, angry) by marking a 100-mm line (ends labeled from not at all to extremely).
Measured: Assessed at post-treatment (2 weeks after baseline).
Frozen Yogurt Consumption
Food intake will be measured as the difference in weight of the frozen yogurt before and after the test meal (Geliebter et al., 2012) that is part of the behavioral stress task. The investigators will also record the time taken (out of fifteen minutes) participants used to consume the food.
Measured: Assessed at post-treatment (2 weeks after baseline).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2017 (estimated)
- Study start28 Mar 2017
- Primary completion3 May 2017
- Study completion3 May 2017
Why it stopped: Data collection suggested that more work was needed to validate the theoretical connections between the constructs of interest, before doing a treatment trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for Eating Disorder SymptomStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pamela K Keel, Ph.D., Principal investigator, Department of Psychology, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03040076
- Sponsor's protocol ID
- 2016.19855
- Other IDs
- 2016
- Status last verified
- Dec 2016
- First submitted
- 4 Jan 2017
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arnow B, Kenardy J, Agras WS. The Emotional Eating Scale: the development of a measure to assess coping with negative affect by eating. Int J Eat Disord. 1995 Jul;18(1):79-90. doi: 10.1002/1098-108x(199507)18:13.0.co;2-v.
PubMed 7670446Van Strien T, Frijters JE, Bergers G, Defares PB. The Dutch Eating Behavior Questionnaire (DEBQ) for assessment of restrained, emotional, and external eating behavior. International Journal of Eating Disorders 5(2): 295-315, 1986.
Masheb RM, Grilo CM. Emotional overeating and its associations with eating disorder psychopathology among overweight patients with binge eating disorder. Int J Eat Disord. 2006 Mar;39(2):141-6. doi: 10.1002/eat.20221.
PubMed 16231349Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
PubMed 3397865Forbush KT, Wildes JE, Pollack LO, Dunbar D, Luo J, Patterson K, Petruzzi L, Pollpeter M, Miller H, Stone A, Bright A, Watson D. Development and validation of the Eating Pathology Symptoms Inventory (EPSI). Psychol Assess. 2013 Sep;25(3):859-78. doi: 10.1037/a0032639. Epub 2013 Jul 1.
PubMed 23815116Spielberger CD, Reheiser EC. Assessment of emotions: Anxiety, anger, depression, and curiosity. Applied Psychology: Health and Well-Being 1(3): 271-302, 2009.
Amir N, Taylor CT. Interpretation training in individuals with generalized social anxiety disorder: a randomized controlled trial. J Consult Clin Psychol. 2012 Jun;80(3):497-511. doi: 10.1037/a0026928. Epub 2012 Jan 16.
PubMed 22250851Beard C, Amir N. A multi-session interpretation modification program: changes in interpretation and social anxiety symptoms. Behav Res Ther. 2008 Oct;46(10):1135-41. doi: 10.1016/j.brat.2008.05.012. Epub 2008 Jun 27.
PubMed 18675400Hindash AHC, Amir N. Negative interpretation bias in individuals with depressive symptoms. Cognitive Therapy and Research 36(5): 502-511, 2012.
Amir N, Bomyea J, Beard C. The effect of single-session interpretation modification on attention bias in socially anxious individuals. J Anxiety Disord. 2010 Mar;24(2):178-82. doi: 10.1016/j.janxdis.2009.10.005. Epub 2009 Oct 27.
PubMed 19926442Cardi V, Esposito M, Bird G, Rhind C, Yiend J, Schifano S, Hirsch C, Treasure J. A preliminary investigation of a novel training to target cognitive biases towards negative social stimuli in Anorexia Nervosa. J Affect Disord. 2015 Dec 1;188:188-93. doi: 10.1016/j.jad.2015.08.019. Epub 2015 Aug 28.
PubMed 26363616Hayes S, Hirsch CR, Krebs G, Mathews A. The effects of modifying interpretation bias on worry in generalized anxiety disorder. Behav Res Ther. 2010 Mar;48(3):171-8. doi: 10.1016/j.brat.2009.10.006. Epub 2009 Oct 14.
PubMed 19857859Hirsch CR, Hayes S, Mathews A. Looking on the bright side: accessing benign meanings reduces worry. J Abnorm Psychol. 2009 Feb;118(1):44-54. doi: 10.1037/a0013473.
PubMed 19222313Rolls BJ, Andersen AE, Moran TH, McNelis AL, Baier HC, Fedoroff IC. Food intake, hunger, and satiety after preloads in women with eating disorders. Am J Clin Nutr. 1992 Jun;55(6):1093-103. doi: 10.1093/ajcn/55.6.1093.
PubMed 1595580Kirschbaum C, Pirke KM, Hellhammer DH. The 'Trier Social Stress Test'--a tool for investigating psychobiological stress responses in a laboratory setting. Neuropsychobiology. 1993;28(1-2):76-81. doi: 10.1159/000119004.
PubMed 8255414
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing if Reductions in Negative Affect Yield Decreased Emotional Eating Symptoms: A Cognitive Bias Intervention
- ClinicalTrials.gov ID
- NCT03040076
- Acronym / sponsor ID
- 2016.19855
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Data collection suggested that more work was needed to validate the theoretical connections between the constructs of interest, before doing a treatment trial.
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 28 Mar 2017 (actual)
- Primary completion
- 3 May 2017 (actual)
- Study completion
- 3 May 2017 (actual)
- First posted
- 2 Feb 2017 (estimated)
- Results
- Not posted in the source record
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 study to test a computerized treatment designed to help people with high levels of emotional eating, which is when people eat to cope with negative emotions and/or stressful situations. The investigators are interested in comparing two different ways of coping with negative emotions, relaxation training or training in how to think differently about such situations. Additionally, the researchers' study seeks to understand more about the psychological factors that may contribute to someone having difficulty with emotional eating.
Detailed description
Emotional eating, or eating as a mechanism for coping with negative affect, is present across a spectrum of eating disorders and is associated with poor health outcomes, namely obesity. Research suggests that individuals with emotional eating experience urges to eat in response to multiple negative emotions, including anxiety, depression, and anger. While emotional eating is related to binge eating, it can be examined in a more dimensional fashion because it is not associated with a specific size criterion or a requirement of loss of control over eating. As such, emotional eating is a useful analog through which to understand mechanisms of binge eating and test the preliminary efficacy of treatment interventions. Interventions that target mechanisms of regulating negative affect may reduce both negative affect and emotional eating, increasing their transdiagnostic value. Research suggests that a large gap exists between the prevalence of psychopathology and access to psychological treatment, and this gap extends to individuals with eating disorders. A potential solution to these challenges is the use of computerized methodologies that may be easier to disseminate, allow for a gradient of treatment intensity, and do not rely upon training treatment providers. Computer-administered CBM interventions address the need for more easily disseminated treatments. CBM interventions are based in research suggesting that negative interpretation biases cause negative emotionality and subsequent symptom expression. Negative interpretation biases are the tendency to draw threatening conclusions about ambiguous information. Thus, CBM paradigms train people to make neutral or positive attributions about situations they would typically view through the lens of their negative biases. CBM interventions have been tested across a range of psychopathology, including anxiety disorders, depression, and anger, and using a variety of different bias modification techniques. Two recent CBM studies have been tested within the field of eating disorders. Although results were promising, both studies were marked by methodological limitations and neither addressed emotional eating specifically. The purpose of the present study is to test a CBM intervention designed to help individuals with elevated emotional eating improve their ability to regulate negative affect. In doing so, the investigators will determine if modifying the interpretation of ambiguous situations that would typically result in negative affect can reduce negative affect in individuals with high emotional eating. The researchers will in turn determine if those individuals have decreased food consumption under conditions that would otherwise elicit negative emotions. This project extends initial research on CBMs in eating disorders, as well as research suggesting that basic emotion regulation training can decrease emotional eating.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Bias Treatment | Experimental | Behavioral: Cognitive Bias TreatmentIntervention condition |
| Relaxation Condition | Active comparator | Behavioral: Relaxation ConditionActive control condition |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female between the ages of 18 and 45 years of age
- An emotional eating score more than one SD above the mean (>2.9) on the Dutch Eating Behavior Questionnaire (DEBQ) emotional eating scale (van Strien, Frijters, Bergers, \& Defares, 1986).
- Regular computer and internet access
- Rate liking of vanilla frozen yogurt as a 6 or higher on a 10 point scale.
Key exclusion criteria (3 listed)
- Body mass index (BMI; kg/m2) less than 18.5 (World Health Organization, 2000), given known cognitive impairments that can result from being underweight (Fowler et al., 2006).
- Current psychotic, manic, or substance use disorders, as these may interfere with their ability to cognitively engage in the intervention.
- Food allergies that would prevent consumption of vanilla frozen yogurt.
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 |
|---|---|---|
| Cognitive Bias TreatmentTwo computerized tasks will be administered during four intervention sessions. During the first task, the Word Sentence Association Paradigm, participants see a threat or benign word and then an ambiguous sentence. Participants press one if they believe the word and sentence are related and two if they believe the word and sentence are not related. Participants are given feedback that they responded correctly if they state that a benign word is related to the sentence or they state that a threat word is not related to the sentence. The second task is the Ambiguous Scenarios Task. In each trial, an ambiguous scenario, ending in a benign word, appears on the screen. After the scenario is presented, participants respond to a comprehension question and are given feedback on their performance. | Behavioural | Cognitive Bias Treatment |
| Relaxation ConditionParticipants assigned to the active control group will complete four sessions of progressive muscle relaxation training. Two alternating relaxation scripts will be used. The scripts will be presented as Youtube videos with a blank black screen and will instruct participants to keep their eyes closed for the duration of the training. Participants will access the videos through Qualtrics to ensure that data can be gathered about their compliance. The relaxation scripts used in the present study will be modified versions of those currently being tested by other researchers utilizing cognitive bias modification paradigms. The relaxation training sessions will be matched to the length of the treatment condition and therefore will last approximately 30 minutes. | Behavioural | Relaxation Condition |
Primary outcome
Change in Emotional Overeating Questionnaire Scores
Time frame: Assessed at baseline (time zero), mid-treatment (8 days after baseline), and post-treatment (2 weeks after baseline).
Emotional eating will be measured using the 6-item Emotional Overeating Questionnaire (EOQ; Masheb \& Grilo, 2006), in which participants report on the frequency of eating in response to five negative emotions and one positive emotion. The instructions and item scaling will be modified to decrease the timeframe assessed from 28 days to 5 days, in order to be sensitive to changes during the present intervention. Each item will be assessed on a 5-point scale (0= no days to 5 = every day). Further, the instructions will be modified to not specifically reference eating an objectively large amount of food. This change is made in order to ensure consistency with how emotional eating is conceptualized in the literature (i.e., no specific size criterion). Change in scores at each of the time points will be used to determine symptom improvement.
Change in Positive and Negative Affect Schedule Scores
Time frame: Assessed at baseline (time zero), mid-treatment (8 days after baseline), and post-treatment (2 weeks after baseline).
Negative affect will be assessed using the negative affect scale of the Positive and Negative Affect Schedule (PANAS; Watson, Clark, \& Tellegen, 1988), which is a 10-item measure of negative emotions on a scale of 1 ("very slightly or not at all) to 5 ("extremely"). The instructions can be modified as needed to reflect the desired timeframe of assessment (Watson et al., 1988) and therefore, we will instruct participants to consider the past five days.Change in scores at each of the time points will be used to determine symptom improvement.
Change in Word Sentence Association Paradigm Scores
Time frame: Assessed at baseline (time zero), mid-treatment (8 days after baseline), and post-treatment (2 weeks after baseline).
A modified version of the treatment condition Word Sentence Association Paradigm (WSAP; Amir \& Taylor, 2012b; Beard \& Amir, 2008; Hindash \& Amir, 2012) will be used to assess interpretation bias. The ambiguous sentences will be distinct from those used in the bias modification program in order to allow for a more generalized assessment of change in biases. However, to permit an accurate assessment of changes in bias, the WSAP task will be the same at pre-, mid and post treatment. Scores on the WSAP task are calculated as the ratio of percent threatening to percent benign interpretations across the trials. Change in scores at each of the time points will be used to determine symptom improvement.
7 secondary outcomes
Body Mass Index
Time frame: Assessed at baseline (time zero).
Eating Pathology Symptoms Inventory
Time frame: Assessed at baseline (time zero) and post-treatment (2 weeks after baseline).
Depression and Anxiety Stress Scale
Time frame: Assessed at baseline (time zero) and post-treatment (2 weeks after baseline).
State-Trait Anger Expression Inventory, Second Edition
Time frame: Assessed at baseline (time zero) and post-treatment (2 weeks after baseline).
Difficulties in Emotion Regulation Scale
Time frame: Assessed at baseline (time zero) and post-treatment (2 weeks after baseline).
Visual Analogue Scale Ratings
Time frame: Assessed at post-treatment (2 weeks after baseline).
Frozen Yogurt Consumption
Time frame: Assessed at post-treatment (2 weeks after baseline).
Results and safety
The study was stopped early (reason given: Data collection suggested that more work was needed to validate the theoretical connections between the constructs of interest, before doing a treatment trial.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- Background: PubMed 7670446Arnow B, Kenardy J, Agras WS. The Emotional Eating Scale: the development of a measure to assess coping with negative affect by eating. Int J Eat Disord. 1995 Jul;18(1):79-90. doi: 10.1002/1098-108x(199507)18:13.0.co;2-v.
- BackgroundVan Strien T, Frijters JE, Bergers G, Defares PB. The Dutch Eating Behavior Questionnaire (DEBQ) for assessment of restrained, emotional, and external eating behavior. International Journal of Eating Disorders 5(2): 295-315, 1986.
- Background: PubMed 16231349Masheb RM, Grilo CM. Emotional overeating and its associations with eating disorder psychopathology among overweight patients with binge eating disorder. Int J Eat Disord. 2006 Mar;39(2):141-6. doi: 10.1002/eat.20221.
- Background: PubMed 3397865Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
- Background: PubMed 23815116Forbush KT, Wildes JE, Pollack LO, Dunbar D, Luo J, Patterson K, Petruzzi L, Pollpeter M, Miller H, Stone A, Bright A, Watson D. Development and validation of the Eating Pathology Symptoms Inventory (EPSI). Psychol Assess. 2013 Sep;25(3):859-78. doi: 10.1037/a0032639. Epub 2013 Jul 1.
- BackgroundSpielberger CD, Reheiser EC. Assessment of emotions: Anxiety, anger, depression, and curiosity. Applied Psychology: Health and Well-Being 1(3): 271-302, 2009.
- Background: PubMed 22250851Amir N, Taylor CT. Interpretation training in individuals with generalized social anxiety disorder: a randomized controlled trial. J Consult Clin Psychol. 2012 Jun;80(3):497-511. doi: 10.1037/a0026928. Epub 2012 Jan 16.
- Background: PubMed 18675400Beard C, Amir N. A multi-session interpretation modification program: changes in interpretation and social anxiety symptoms. Behav Res Ther. 2008 Oct;46(10):1135-41. doi: 10.1016/j.brat.2008.05.012. Epub 2008 Jun 27.
- BackgroundHindash AHC, Amir N. Negative interpretation bias in individuals with depressive symptoms. Cognitive Therapy and Research 36(5): 502-511, 2012.
- Background: PubMed 19926442Amir N, Bomyea J, Beard C. The effect of single-session interpretation modification on attention bias in socially anxious individuals. J Anxiety Disord. 2010 Mar;24(2):178-82. doi: 10.1016/j.janxdis.2009.10.005. Epub 2009 Oct 27.
- Background: PubMed 26363616Cardi V, Esposito M, Bird G, Rhind C, Yiend J, Schifano S, Hirsch C, Treasure J. A preliminary investigation of a novel training to target cognitive biases towards negative social stimuli in Anorexia Nervosa. J Affect Disord. 2015 Dec 1;188:188-93. doi: 10.1016/j.jad.2015.08.019. Epub 2015 Aug 28.
- Background: PubMed 19857859Hayes S, Hirsch CR, Krebs G, Mathews A. The effects of modifying interpretation bias on worry in generalized anxiety disorder. Behav Res Ther. 2010 Mar;48(3):171-8. doi: 10.1016/j.brat.2009.10.006. Epub 2009 Oct 14.
- Individual participant dataSharing planned: No
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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.
Pamela K Keel, Ph.D. principal investigator
Department of Psychology, Florida State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Bias Treatment and Relaxation Condition in people with Eating Disorder Symptom and Emotional Maladjustment, run by Florida State University 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 4 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: stopped early, as of the sponsor's last update on 26 Jun 2018. 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?
The study was stopped early (reason given: Data collection suggested that more work was needed to validate the theoretical connections between the constructs of interest, before doing a treatment trial.). Results are not available in the source record.
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?
Change in Emotional Overeating Questionnaire Scores (time frame: Assessed at baseline (time zero), mid-treatment (8 days after baseline), and post-treatment (2 weeks after baseline).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03040076, which also lists 35 linked publications.
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 26 Jun 2018.