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Pilot Intervention for Social Biases in Eating Disorders (SBPI)

Primary Purpose

Eating Disorders, Anorexia Nervosa, Bulimia Nervosa

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Self-Blame and Perspective-Taking Intervention
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eating Disorders

Eligibility Criteria

18 Years - 64 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • UTSW

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Self-Blame and Perspective-Taking Intervention

Arm Description

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

Outcomes

Primary Outcome Measures

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).
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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)
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.
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.
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).
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.
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.

Full Information

First Posted
May 3, 2021
Last Updated
May 3, 2021
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04877158
Brief Title
Pilot Intervention for Social Biases in Eating Disorders
Acronym
SBPI
Official Title
Pilot Intervention for Attribution Biases in Eating Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
January 31, 2018 (Actual)
Primary Completion Date
July 20, 2019 (Actual)
Study Completion Date
July 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorders, Anorexia Nervosa, Bulimia Nervosa, Binge-Eating Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Self-Blame and Perspective-Taking Intervention
Arm Type
Experimental
Arm Description
These participants are enrolled with intent to participate in the group therapy intervention.
Intervention Type
Behavioral
Intervention Name(s)
Self-Blame and Perspective-Taking Intervention
Intervention Description
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 Outcome Measure Information:
Title
Change in self- attribution (externalizing bias score) from Pre-assessment to Post-assessment 1
Description
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).
Time Frame
Baseline, 4 weeks after intervention
Title
Change in state self-esteem score from Pre-assessment to Post-assessment 1
Description
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.
Time Frame
Baseline, 4 weeks after intervention
Title
Change in trait self-esteem score from Pre-assessment to Post-assessment 1
Description
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.
Time Frame
Baseline, 4 weeks after intervention
Title
Study components feedback score
Description
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.
Time Frame
4 weeks after starting intervention
Title
Patient satisfaction score
Description
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.
Time Frame
5-9 weeks after intervention
Title
Change in eating disorder symptoms score from Pre- assessment to Post-assessment 1
Description
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.
Time Frame
Baseline, 4 weeks after intervention
Secondary Outcome Measure Information:
Title
Change in depression symptoms scores from Pre-assessment to Post-assessment 1
Description
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.
Time Frame
Baseline, 4 weeks after intervention
Title
Change in depression symptoms scores from Pre-assessment to Post-assessment 2
Description
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.
Time Frame
Baseline, 3-5 months after intervention
Title
Change in anxiety symptoms score from Pre-assessment to Post-assessment 1
Description
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)
Time Frame
Baseline, 4 weeks after intervention
Title
Change in anxiety symptoms score from Pre-assessment to Post-assessment 2
Description
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.
Time Frame
Baseline, 3-5 months after intervention
Title
Change in eating disorder symptoms score from Pre-assessment to Post-assessment 2
Description
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.
Time Frame
Baseline, 3-5 months after intervention
Title
Change in self- attribution (externalizing bias score) from Pre-assessment to Post-assessment 2
Description
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).
Time Frame
Baseline, 3-5 months after intervention
Title
Change in state self-esteem score from Pre-assessment to Post-assessment 2
Description
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.
Time Frame
Baseline, 3-5 months after intervention
Title
Change in trait self-esteem score from Pre-assessment to Post-assessment 2
Description
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.
Time Frame
Baseline, 3-5 months after intervention

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female participants only
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carrie McAdams, MD PhD
Organizational Affiliation
University of Texas Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UTSW
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8828
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34649621
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.
Results Reference
derived

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Pilot Intervention for Social Biases in Eating Disorders

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