Pilot Intervention for Social Biases in Eating Disorders

Anorexia Nervosa Clinical Trial

— SBPI  

Official title:

Pilot Intervention for Attribution Biases in Eating Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04877158
• Other study ID #: STU-042016-079
• Status: Completed
• Phase: N/A
• Start date: January 31, 2018
• Est. completion date: July 20, 2019

Study information

• Verified date: May 2021
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: July 20, 2019
• Est. primary completion date: July 20, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Binge-Eating Disorder
• Bulimia
• Bulimia Nervosa
• Disease
• Eating Disorders
• Feeding and Eating Disorders

Intervention

Behavioral:
• Self-Blame and Perspective-Taking Intervention
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.

Locations

Country	Name	City	State
United States	UTSW	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline, 4 weeks after intervention
Primary	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.	Baseline, 4 weeks after intervention
Primary	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.	Baseline, 4 weeks after intervention
Primary	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.	4 weeks after starting intervention
Primary	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.	5-9 weeks after intervention
Primary	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.	Baseline, 4 weeks after intervention
Secondary	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.	Baseline, 4 weeks after intervention
Secondary	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.	Baseline, 3-5 months after intervention
Secondary	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)	Baseline, 4 weeks after intervention
Secondary	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.	Baseline, 3-5 months after intervention
Secondary	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.	Baseline, 3-5 months after intervention
Secondary	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).	Baseline, 3-5 months after intervention
Secondary	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.	Baseline, 3-5 months after intervention
Secondary	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.	Baseline, 3-5 months after intervention