Clinical trial NCT04877158: Pilot Intervention for Social Biases in Eating Disorders
Official title: Pilot Intervention for Attribution Biases in Eating Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Disorders
Anorexia Nervosa
Bulimia Nervosa
Binge-Eating Disorder
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2021-05-07
Enrollment: 29
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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.

A. 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)

B. 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).

1. Internal, Personal, and Situational Attribution Questionnaire, (IPSAQ)
2. State Self-Esteem Scale (SSE)
3. Trait Self-Esteem Scale (TSE)
4. Eating Disorder Examination Questionnaire, (EDE-Q)
5. The Quick Inventory of Depression, Clinician-Rated (QIDS)
6. Structured Interview Guide for Hamilton Anxiety Scale (SIGH-A)

C. Feedback about the intervention is obtained from queries immediately after the last session and at the follow-up visits.

Eligibility criteria: Inclusion Criteria:

* eating disorder, current or recent
* female
* appropriate for partial hospital, intensive outpatient or outpatient treatment

Exclusion Criteria:

* medically unstable
* in inpatient or residential treatment

Primary outcomes:
measure: Change in self- attribution (externalizing bias score) from Pre-assessment to Post-assessment 1
timeFrame: Baseline, 4 weeks after intervention
measure: Change in state self-esteem score from Pre-assessment to Post-assessment 1
timeFrame: Baseline, 4 weeks after intervention
measure: Change in trait self-esteem score from Pre-assessment to Post-assessment 1
timeFrame: Baseline, 4 weeks after intervention
measure: Study components feedback score
timeFrame: 4 weeks after starting intervention
measure: Patient satisfaction score
timeFrame: 5-9 weeks after intervention
measure: Change in eating disorder symptoms score from Pre- assessment to Post-assessment 1
timeFrame: Baseline, 4 weeks after intervention
Secondary outcomes:
measure: Change in depression symptoms scores from Pre-assessment to Post-assessment 1
timeFrame: Baseline, 4 weeks after intervention
measure: Change in depression symptoms scores from Pre-assessment to Post-assessment 2
timeFrame: Baseline, 3-5 months after intervention
measure: Change in anxiety symptoms score from Pre-assessment to Post-assessment 1
timeFrame: Baseline, 4 weeks after intervention
measure: Change in anxiety symptoms score from Pre-assessment to Post-assessment 2
timeFrame: Baseline, 3-5 months after intervention
measure: Change in eating disorder symptoms score from Pre-assessment to Post-assessment 2
timeFrame: Baseline, 3-5 months after intervention
measure: Change in self- attribution (externalizing bias score) from Pre-assessment to Post-assessment 2
timeFrame: Baseline, 3-5 months after intervention
measure: Change in state self-esteem score from Pre-assessment to Post-assessment 2
timeFrame: Baseline, 3-5 months after intervention
measure: Change in trait self-esteem score from Pre-assessment to Post-assessment 2
timeFrame: Baseline, 3-5 months after intervention
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UTSW
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Carrie McAdams, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.