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Completed

NCT Number: NCT04877158

Pilot Intervention for Social 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.

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Key information

Conditions

Eating Disorders Anorexia Nervosa Binge-Eating Disorder Bulimia Nervosa Feeding and Eating Disorders Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UTSW

Dallas, Texas, 75390-8828, United States

About this study

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).

  • 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)

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

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

    Time frame: Baseline, 4 weeks after intervention

    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.

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

    Time frame: Baseline, 3-5 months after intervention

    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.

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

    Time frame: Baseline, 4 weeks after intervention

    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)

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

    Time frame: Baseline, 3-5 months after intervention

    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.

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

    Time frame: Baseline, 3-5 months 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.

  6. Change in self- attribution (externalizing bias score) from Pre-assessment to Post-assessment 2

    Time frame: Baseline, 3-5 months 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 therefore indicates strong self-serving bias (blaming oneself less for negative events than for positive events).

  7. Change in state self-esteem score from Pre-assessment to Post-assessment 2

    Time frame: Baseline, 3-5 months 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.

  8. Change in trait self-esteem score from Pre-assessment to Post-assessment 2

    Time frame: Baseline, 3-5 months 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.

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

Pilot Intervention for Attribution Biases in Eating Disorders

Acronym: SBPI

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 7, 2021
Registry last updated
May 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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