Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2026-01-02 @ 2:44 AM
Study NCT ID:
NCT04877158
Status:
COMPLETED
Last Update Posted:
2021-05-07
First Post:
2021-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Intervention for Social Biases in Eating Disorders
Sponsor:
University of Texas Southwestern Medical Center
Organization:
Study Overview
Official Title:
Pilot Intervention for Attribution Biases in Eating Disorders
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SBPI
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: