Eating DisordersSBPINCT04877158
Pilot Intervention for Social Biases in Eating Disorders
A study testing Self-Blame and Perspective-Taking Intervention in people with Eating Disorders and Anorexia Nervosa, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Both behavioral, psychological, and cognitive differences related to social cognitive function have been related to illness-state in eating disorders, but interventions that directly target these problems are limited. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Eating Disorders, Anorexia Nervosa, Bulimia Nervosa
- What is being tested?
- Self-Blame and Perspective-Taking Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2018to 20 Jul 2019
- 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 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- eating disorder, current or recent
- female
- appropriate for partial hospital, intensive outpatient or outpatient treatment
Who cannot join
- medically unstable
- in inpatient or residential treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Intervention for Attribution Biases in Eating Disorders
Both behavioral, psychological, and cognitive differences related to social cognitive function have been related to illness-state in eating disorders, but interventions that directly target these problems are limited. This pilot intervention explores whether a brief art-therapy team-building intervention coupled with psychoeducation about social behavior can change self-concept or clinical symptoms in patients with eating disorders. Participants will complete pre-treatment assessments related to social behaviors and clinical symptoms, attend four two-hour group sessions, and provide two follow-up post-treatment assessments at 1-4 weeks after the treatment and 3-5 months later. Comparisons between the pre-intervention data and the first follow-up will be the primary outcome measures. The primary hypotheses are that participants will show increases in self-esteem and positive self-attributions and decreases in eating disorder symptoms after the intervention. The secondary hypothesis is that other clinical symptoms (depression, anxiety) will be improved after the intervention. Feedback from participants about their experience with the study will assess perceived benefits as well as acquisition of the psychoeducation targets.
Read the detailed description
This project will recruit subjects with eating disorders in the Dallas Fort Worth area. Pre-assessment measures of anxiety, self-esteem, depression, eating disorder symptoms, and attributional style will be completed before the intervention. Participants attend four weekly sessions of a group psychoeducational intervention. The intervention includes an art therapy experiential activity, psychoeducation on social function, reflection and discussion of sample videos and scripts, homework assignments, and guided discussions. Post-assessments will be completed 1-4 weeks and 3-5 months after the interventions is completed.
- Intake and Screen: Screening checklist for ED symptoms. Demographic Sheet; Clinical History (low BMI); Mini-International Neuropsychiatric Interview for DSM-V (MINI); Eating Disorder Assessment for DSM-V (EDA-5); Wechsler Abbreviated Scale of Intelligence (WASI)
- Pre/Post Measures (Done at three time points, Pre:1-4 weeks before intervention; Post1: 1-4 weeks after intervention; and Post2: 3-5 months after intervention).
- Internal, Personal, and Situational Attribution Questionnaire, (IPSAQ)
- State Self-Esteem Scale (SSE)
- Trait Self-Esteem Scale (TSE)
- Eating Disorder Examination Questionnaire, (EDE-Q)
- The Quick Inventory of Depression, Clinician-Rated (QIDS)
- Structured Interview Guide for Hamilton Anxiety Scale (SIGH-A)
- Feedback about the intervention is obtained from queries immediately after the last session and at the follow-up visits.
- Being tested
- Self-Blame and Perspective-Taking Intervention
- Medical subject headings
- Feeding and Eating Disorders, Anorexia Nervosa, Bulimia Nervosa, Binge-Eating Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Blame and Perspective-Taking InterventionBehavioural
The intervention is a group therapy that consists of experiential art tasks followed by psychoeducation about social behaviors with weekly homework. There are four sessions, each one week apart.
| Study group | Role | What they receive |
|---|---|---|
| Self-Blame and Perspective-Taking Intervention | Experimental | These participants are enrolled with intent to participate in the group therapy intervention. Receives: Behavioral: Self-Blame and Perspective-Taking Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self- attribution (externalizing bias score) from Pre-assessment to Post-assessment 1
Internal Personal Situational Attributions Questionnaire (IPSAQ) measures externalizing bias (EB) that is calculated by subtracting the number of internal attributions for negative events from the number of internal attributions for positive events. A positive EB score indicates strong self-serving bias (blaming oneself less for negative events than for positive events).
Measured: Baseline, 4 weeks after intervention
Change in state self-esteem score from Pre-assessment to Post-assessment 1
State Self-Esteem Scale measures a participant's self-esteem at a given point in time. Possible scores range from 0-5 with higher scores indicating better outcome.
Measured: Baseline, 4 weeks after intervention
Change in trait self-esteem score from Pre-assessment to Post-assessment 1
Rosenberg trait self-esteem scale measures trait self-esteem (TSE). Possible scores range from 0-4 (from 1: strongly disagree, to 4: strongly agree), with higher scores indicating higher TSE.
Measured: Baseline, 4 weeks after intervention
Study components feedback score
The Attribution Bias Intervention Questionnaire addressed study component feedback using both a rating scales and free form written commentary. Possible scores range from 1 to 10 with higher scores indicating more positive values.
Measured: 4 weeks after starting intervention
Patient satisfaction score
The Attribution Bias Feedback Form measured patient satisfaction (the impact and value of study) with free-form verbal responses as well as a single rating scale. Possible scores range from 1 to 5 with higher scores indicating more satisfaction with the intervention.
Measured: 5-9 weeks after intervention
Change in eating disorder symptoms score from Pre- assessment to Post-assessment 1
The Eating Disorder Examination Questionnaire measures the severity of eating disorder symptoms. Possible scores on global eating disorder pathology range from 0 to 6 with higher scores indicating more severity of eating disorder, with scores of 2 or less typical of normative eating behavior/cognitions and scores of 2 to 6 are consistent with eating disorder symptoms, with higher scores suggesting more types of disordered eating are present.
Measured: Baseline, 4 weeks after intervention
Secondary outcomes (8)
Change in depression symptoms scores from Pre-assessment to Post-assessment 1
QIDS (Quick Inventory of Depressive Symptoms) measures depression symptoms. Possible scores range from 0-27, with scores of 5 or lower indicative of no depression, scores from 6 to 10 indicating mild depression, 11 to 15 indicating moderate depression, 16 to 20 reflecting severe depression, and total scores greater than 21 indicating very severe depression.
Measured: Baseline, 4 weeks after intervention
Change in depression symptoms scores from Pre-assessment to Post-assessment 2
QIDS (Quick Inventory of Depressive Symptoms) measures depression symptoms. Possible scores range from 0-27, with scores of 5 or lower indicative of no depression, scores from 6 to 10 indicating mild depression, 11 to 15 indicating moderate depression, 16 to 20 reflecting severe depression, and total scores greater than 21 indicating very severe depression.
Measured: Baseline, 3-5 months after intervention
Change in anxiety symptoms score from Pre-assessment to Post-assessment 1
SIGH-A (Structured Clinical Interview for Hamilton Anxiety Scale) measures Anxiety symptoms. Possible scores range from 0-56 with score of 0 means no anxiety symptom. ( <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Lower scores indicate better outcome)
Measured: Baseline, 4 weeks after intervention
Change in anxiety symptoms score from Pre-assessment to Post-assessment 2
SIGH-A (Structured Clinical Interview for Hamilton Anxiety Scale) measures anxiety symptoms. Possible scores range from 0-56 with score of 0 means no anxiety symptom ; <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Lower scores indicate better outcome.
Measured: Baseline, 3-5 months after intervention
Change in eating disorder symptoms score from Pre-assessment to Post-assessment 2
The Eating Disorder Examination Questionnaire measures the severity of eating disorder symptoms. Possible scores on global eating disorder pathology range from 0 to 6 with higher scores indicating more severity of eating disorder, with scores of 2 or less typical of normative eating behavior/cognitions and scores of 2 to 6 are consistent with eating disorder symptoms, with higher scores suggesting more types of disordered eating are present.
Measured: Baseline, 3-5 months after intervention
Change in self- attribution (externalizing bias score) from Pre-assessment to Post-assessment 2
Internal Personal Situational Attributions Questionnaire (IPSAQ) measures externalizing bias (EB) that is calculated by subtracting the number of internal attributions for negative events from the number of internal attributions for positive events. A positive EB score therefore indicates strong self-serving bias (blaming oneself less for negative events than for positive events).
Measured: Baseline, 3-5 months after intervention
Change in state self-esteem score from Pre-assessment to Post-assessment 2
State self-esteem scale measures a participant's self-esteem at a given point in time. Possible scores range from 0-5 with higher scores indicating better outcome.
Measured: Baseline, 3-5 months after intervention
Change in trait self-esteem score from Pre-assessment to Post-assessment 2
Rosenberg trait self-esteem scale measures Trait Self-Esteem (TSE). Possible scores range from 0-4 (from 1: strongly disagree, to 4: strongly agree), with higher scores indicating higher TSE.
Measured: Baseline, 3-5 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start31 Jan 2018
- Primary completion20 Jul 2019
- Study completion20 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Self-concept measures (Attribution Biases, Self-Esteem) and psychological symptoms (Eating, depression, anxiety) will be assessed before and after completion of the group.
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carrie McAdams, University of Texas Southwestern Medical Center
- Investigators
- Carrie McAdams, MD PhD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04877158
- Sponsor's protocol ID
- STU-042016-079
- Acronym
- SBPI
- Status last verified
- May 2021
- First submitted
- 3 May 2021
- Last updated
- 7 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hagan WS, Mericle S, Hunt BJ, Harper JA, Palka JM, Pelfrey S, McAdams CJ. Qualitative patient experiences from the Self-Blame and Perspective-Taking Intervention for eating disorders. J Eat Disord. 2021 Oct 14;9(1):127. doi: 10.1186/s40337-021-00483-9.
PubMed 34649621
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Intervention for Attribution Biases in Eating Disorders
- ClinicalTrials.gov ID
- NCT04877158
- Acronym / sponsor ID
- SBPI / STU-042016-079
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 31 Jan 2018 (actual)
- Primary completion
- 20 Jul 2019 (actual)
- Study completion
- 20 Jul 2019 (actual)
- First posted
- 7 May 2021 (actual)
- 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.
Both behavioral, psychological, and cognitive differences related to social cognitive function have been related to illness-state in eating disorders, but interventions that directly target these problems are limited. This pilot intervention explores whether a brief art-therapy team-building intervention coupled with psychoeducation about social behavior can change self-concept or clinical symptoms in patients with eating disorders. Participants will complete pre-treatment assessments related to social behaviors and clinical symptoms, attend four two-hour group sessions, and provide two follow-up post-treatment assessments at 1-4 weeks after the treatment and 3-5 months later. Comparisons between the pre-intervention data and the first follow-up will be the primary outcome measures. The primary hypotheses are that participants will show increases in self-esteem and positive self-attributions and decreases in eating disorder symptoms after the intervention. The secondary hypothesis is that other clinical symptoms (depression, anxiety) will be improved after the intervention. Feedback from participants about their experience with the study will assess perceived benefits as well as acquisition of the psychoeducation targets.
Detailed description
This project will recruit subjects with eating disorders in the Dallas Fort Worth area. Pre-assessment measures of anxiety, self-esteem, depression, eating disorder symptoms, and attributional style will be completed before the intervention. Participants attend four weekly sessions of a group psychoeducational intervention. The intervention includes an art therapy experiential activity, psychoeducation on social function, reflection and discussion of sample videos and scripts, homework assignments, and guided discussions. Post-assessments will be completed 1-4 weeks and 3-5 months after the interventions is completed.
- Intake and Screen: Screening checklist for ED symptoms. Demographic Sheet; Clinical History (low BMI); Mini-International Neuropsychiatric Interview for DSM-V (MINI); Eating Disorder Assessment for DSM-V (EDA-5); Wechsler Abbreviated Scale of Intelligence (WASI)
- Pre/Post Measures (Done at three time points, Pre:1-4 weeks before intervention; Post1: 1-4 weeks after intervention; and Post2: 3-5 months after intervention).
- Internal, Personal, and Situational Attribution Questionnaire, (IPSAQ)
- State Self-Esteem Scale (SSE)
- Trait Self-Esteem Scale (TSE)
- Eating Disorder Examination Questionnaire, (EDE-Q)
- The Quick Inventory of Depression, Clinician-Rated (QIDS)
- Structured Interview Guide for Hamilton Anxiety Scale (SIGH-A)
- Feedback about the intervention is obtained from queries immediately after the last session and at the follow-up visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Self-concept measures (Attribution Biases, Self-Esteem) and psychological symptoms (Eating, depression, anxiety) will be assessed before and after completion of the group.
| Arm | Type | Receives |
|---|---|---|
| Self-Blame and Perspective-Taking Intervention | Experimental | Behavioral: Self-Blame and Perspective-Taking InterventionThese participants are enrolled with intent to participate in the group therapy intervention. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- eating disorder, current or recent
- female
- appropriate for partial hospital, intensive outpatient or outpatient treatment
Key exclusion criteria (2 listed)
- medically unstable
- in inpatient or residential treatment
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 |
|---|---|---|
| Self-Blame and Perspective-Taking InterventionThe intervention is a group therapy that consists of experiential art tasks followed by psychoeducation about social behaviors with weekly homework. There are four sessions, each one week apart. | Behavioural | Self-Blame and Perspective-Taking Intervention |
Primary outcome
Change in self- attribution (externalizing bias score) from Pre-assessment to Post-assessment 1
Time frame: Baseline, 4 weeks after intervention
Internal Personal Situational Attributions Questionnaire (IPSAQ) measures externalizing bias (EB) that is calculated by subtracting the number of internal attributions for negative events from the number of internal attributions for positive events. A positive EB score indicates strong self-serving bias (blaming oneself less for negative events than for positive events).
Change in state self-esteem score from Pre-assessment to Post-assessment 1
Time frame: Baseline, 4 weeks after intervention
State Self-Esteem Scale measures a participant's self-esteem at a given point in time. Possible scores range from 0-5 with higher scores indicating better outcome.
Change in trait self-esteem score from Pre-assessment to Post-assessment 1
Time frame: Baseline, 4 weeks after intervention
Rosenberg trait self-esteem scale measures trait self-esteem (TSE). Possible scores range from 0-4 (from 1: strongly disagree, to 4: strongly agree), with higher scores indicating higher TSE.
Study components feedback score
Time frame: 4 weeks after starting intervention
The Attribution Bias Intervention Questionnaire addressed study component feedback using both a rating scales and free form written commentary. Possible scores range from 1 to 10 with higher scores indicating more positive values.
Patient satisfaction score
Time frame: 5-9 weeks after intervention
The Attribution Bias Feedback Form measured patient satisfaction (the impact and value of study) with free-form verbal responses as well as a single rating scale. Possible scores range from 1 to 5 with higher scores indicating more satisfaction with the intervention.
Change in eating disorder symptoms score from Pre- assessment to Post-assessment 1
Time frame: Baseline, 4 weeks after intervention
The Eating Disorder Examination Questionnaire measures the severity of eating disorder symptoms. Possible scores on global eating disorder pathology range from 0 to 6 with higher scores indicating more severity of eating disorder, with scores of 2 or less typical of normative eating behavior/cognitions and scores of 2 to 6 are consistent with eating disorder symptoms, with higher scores suggesting more types of disordered eating are present.
8 secondary outcomes
Change in depression symptoms scores from Pre-assessment to Post-assessment 1
Time frame: Baseline, 4 weeks after intervention
Change in depression symptoms scores from Pre-assessment to Post-assessment 2
Time frame: Baseline, 3-5 months after intervention
Change in anxiety symptoms score from Pre-assessment to Post-assessment 1
Time frame: Baseline, 4 weeks after intervention
Change in anxiety symptoms score from Pre-assessment to Post-assessment 2
Time frame: Baseline, 3-5 months after intervention
Change in eating disorder symptoms score from Pre-assessment to Post-assessment 2
Time frame: Baseline, 3-5 months after intervention
Change in self- attribution (externalizing bias score) from Pre-assessment to Post-assessment 2
Time frame: Baseline, 3-5 months after intervention
Change in state self-esteem score from Pre-assessment to Post-assessment 2
Time frame: Baseline, 3-5 months after intervention
Change in trait self-esteem score from Pre-assessment to Post-assessment 2
Time frame: Baseline, 3-5 months after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
- Derived from this study: PubMed 34649621Hagan WS, Mericle S, Hunt BJ, Harper JA, Palka JM, Pelfrey S, McAdams CJ. Qualitative patient experiences from the Self-Blame and Perspective-Taking Intervention for eating disorders. J Eat Disord. 2021 Oct 14;9(1):127. doi: 10.1186/s40337-021-00483-9.
- 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.
Carrie McAdams, MD PhD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Blame and Perspective-Taking Intervention in people with Eating Disorders and Anorexia Nervosa, run by University of Texas Southwestern Medical Center 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 3 inclusion and 2 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 7 May 2021. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 self- attribution (externalizing bias score) from Pre-assessment to Post-assessment 1 (time frame: Baseline, 4 weeks after intervention). The study lists 6 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 NCT04877158, which also lists 1 linked publication.
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 7 May 2021.