Pilot Intervention for Social Biases in Eating Disorders

NCT04877158 | Completed

• 1 other identifier: STU-042016-079
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Eating Disorders; Anorexia Nervosa; Bulimia Nervosa; Binge-Eating Disorder

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (8)

• Change in depression symptoms scores from Pre-assessment to Post-assessment 1

  Baseline, 4 weeks after intervention

• Change in depression symptoms scores from Pre-assessment to Post-assessment 2

  Baseline, 3-5 months after intervention

• Change in anxiety symptoms score from Pre-assessment to Post-assessment 1

  Baseline, 4 weeks after intervention

• Change in anxiety symptoms score from Pre-assessment to Post-assessment 2

  Baseline, 3-5 months after intervention

• Change in eating disorder symptoms score from Pre-assessment to Post-assessment 2

  Baseline, 3-5 months after intervention

Study Arms (1)

Self-Blame and Perspective-Taking Intervention

EXPERIMENTAL

These participants are enrolled with intent to participate in the group therapy intervention.

Behavioral: Self-Blame and Perspective-Taking Intervention

Interventions

Self-Blame and Perspective-Taking Intervention BEHAVIORAL

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.

Self-Blame and Perspective-Taking Intervention

Eligibility Criteria

• Age: 18 Years - 64 Years
• Gender Eligibility Details: Female participants only
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• medically unstable
• in inpatient or residential treatment

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UTSW

Dallas, Texas, 75390-8828, United States

Location

Related Publications (1)

• 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.

  PMID: 34649621 DERIVED

MeSH Terms

Conditions

Feeding and Eating Disorders; Anorexia Nervosa; Bulimia Nervosa; Binge-Eating Disorder

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Carrie McAdams, MD PhD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: Self-concept measures (Attribution Biases, Self-Esteem) and psychological symptoms (Eating, depression, anxiety) will be assessed before and after completion of the group.

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 7, 2021
• Study Start: January 31, 2018
• Primary Completion: July 20, 2019
• Study Completion: July 20, 2019
• Last Updated: May 7, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)