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Eating Disorders Programs: An Indicated Trial

Primary Purpose

Body Image, Eating Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group-based Therapy
Sponsored by
Oregon Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Body Image

Eligibility Criteria

18 Years - 30 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Participant indicates sub-threshold or threshold eating disorder.
  • Participant is available to participate in the intervention sessions.
  • Participants must be MRI eligible.

Exclusion Criteria:

  • Participant does not indicate sub-threshold or threshold eating disorder.
  • Participant is unable to attend intervention sessions.
  • Participant cannot participate if MRI ineligible.

Sites / Locations

  • Oregon Research Institute
  • Drexel University
  • The University of Texas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Counter-attitudinal therapy

Educational-support group

Arm Description

Counter-attitudinal therapy (CAT) is dissonance-based group intervention. CAT consists of behavioral, written, and verbal exercises in which participants discuss the costs of pursuing the thin ideal and behaviors that are used to pursue the thin ideal. The intervention is 8 sessions long (1-hr each) and is administered by a trained facilitator who uses an intervention script. Participants will be asked to complete weekly home exercises throughout the course of the intervention.

The educational support group intervention that is representative of typical treatment groups offered at universities and community settings. For the current study, the educational support group was designed to match the dissonance group on treatment modality (group-based), duration (8 1-hr sessions), and use of an intervention script administered by a trained facilitator. In the intervention sessions, participants will be provided with a basic education about eating disorders, support for themselves and fellow group members, and learn mindfulness techniques.Participants will be asked to complete weekly homework assignments.

Outcomes

Primary Outcome Measures

Change from Baseline Eating Disorder Diagnostic responses using the Eating Disorder Examination questionnaire at 8 weeks and 6 months
Evaluate change (if any) by using the Eating Disorder Examination questionnaire at the 8 week and 6 month mark.

Secondary Outcome Measures

Assessments using Ideal-Body Stereotype Scale-Revised
Evaluate the participants' perception of the ideal-body stereotype
Assessments using Satisfaction and Dissatisfaction with Body Parts Scale
Evaluate participants' level of satisfaction and dissatisfaction with specific parts of their bodies
Assessments using Dutch Restrained Eating Scale
Evaluate participants ability to exercise restraint in regards to food
Assessments using Positive Affect and Negative Affect Scale-Revised
Measure participants' affect and monitor any changes that may occur.
Assessments using Beliefs About Appearance Scale
Evaluate participants' perceptions and beliefs on physical appearance.

Full Information

First Posted
March 29, 2017
Last Updated
May 1, 2018
Sponsor
Oregon Research Institute
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT03259347
Brief Title
Eating Disorders Programs: An Indicated Trial
Official Title
Eating Disorders Programs: An Indicated Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
June 1, 2012 (Actual)
Primary Completion Date
April 1, 2018 (Actual)
Study Completion Date
April 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oregon Research Institute
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this study is to assess the effectiveness of two body acceptance programs for women. Participants may experience reduction of eating pathology and prevention of future obesity and eating disorders; may derive a sense of altruism and contribution to furthering understanding of a public health problem.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Image, Eating Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
534 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Counter-attitudinal therapy
Arm Type
Experimental
Arm Description
Counter-attitudinal therapy (CAT) is dissonance-based group intervention. CAT consists of behavioral, written, and verbal exercises in which participants discuss the costs of pursuing the thin ideal and behaviors that are used to pursue the thin ideal. The intervention is 8 sessions long (1-hr each) and is administered by a trained facilitator who uses an intervention script. Participants will be asked to complete weekly home exercises throughout the course of the intervention.
Arm Title
Educational-support group
Arm Type
Active Comparator
Arm Description
The educational support group intervention that is representative of typical treatment groups offered at universities and community settings. For the current study, the educational support group was designed to match the dissonance group on treatment modality (group-based), duration (8 1-hr sessions), and use of an intervention script administered by a trained facilitator. In the intervention sessions, participants will be provided with a basic education about eating disorders, support for themselves and fellow group members, and learn mindfulness techniques.Participants will be asked to complete weekly homework assignments.
Intervention Type
Behavioral
Intervention Name(s)
Group-based Therapy
Intervention Description
Young women with body dissatisfaction will be randomized to one of two conditions: 1) an educational-support group condition; or 2) a counter-attitudinal therapy condition. We will test if a brief dissonance-based eating disorder prevention program produces intervention effects when delivered to participants with sub-threshold and threshold eating disorders.
Primary Outcome Measure Information:
Title
Change from Baseline Eating Disorder Diagnostic responses using the Eating Disorder Examination questionnaire at 8 weeks and 6 months
Description
Evaluate change (if any) by using the Eating Disorder Examination questionnaire at the 8 week and 6 month mark.
Time Frame
Measured at baseline, week 8, and Month 6
Secondary Outcome Measure Information:
Title
Assessments using Ideal-Body Stereotype Scale-Revised
Description
Evaluate the participants' perception of the ideal-body stereotype
Time Frame
Measured at baseline, week 8, and Month 6
Title
Assessments using Satisfaction and Dissatisfaction with Body Parts Scale
Description
Evaluate participants' level of satisfaction and dissatisfaction with specific parts of their bodies
Time Frame
Measured at baseline, week 8, and Month 6
Title
Assessments using Dutch Restrained Eating Scale
Description
Evaluate participants ability to exercise restraint in regards to food
Time Frame
Measured at baseline, week 8, and Month 6
Title
Assessments using Positive Affect and Negative Affect Scale-Revised
Description
Measure participants' affect and monitor any changes that may occur.
Time Frame
Measured at baseline, week 8, and Month 6
Title
Assessments using Beliefs About Appearance Scale
Description
Evaluate participants' perceptions and beliefs on physical appearance.
Time Frame
Measured at baseline, week 8, and Month 6

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participant indicates sub-threshold or threshold eating disorder. Participant is available to participate in the intervention sessions. Participants must be MRI eligible. Exclusion Criteria: Participant does not indicate sub-threshold or threshold eating disorder. Participant is unable to attend intervention sessions. Participant cannot participate if MRI ineligible.
Facility Information:
Facility Name
Oregon Research Institute
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97403
Country
United States
Facility Name
Drexel University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
The University of Texas
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30570303
Citation
Stice E, Rohde P, Shaw H, Gau JM. Randomized trial of a dissonance-based group treatment for eating disorders versus a supportive mindfulness group treatment. J Consult Clin Psychol. 2019 Jan;87(1):79-90. doi: 10.1037/ccp0000365.
Results Reference
derived

Learn more about this trial

Eating Disorders Programs: An Indicated Trial

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