Eating Disorders Programs: An Indicated Trial

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.

Study Overview

• Status: Completed
• Conditions: Body Image; Eating Disorders
• Intervention / Treatment: Behavioral: Group-based Therapy

• Study Type: Interventional
• Enrollment (Anticipated): 534
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Eugene, Oregon, United States, 97403
      • Oregon Research Institute
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Drexel University
  • Texas
    • Austin, Texas, United States, 78712
      • The University Of Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Counter-attitudinal therapy; 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.	Behavioral: Group-based Therapy; 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.
ACTIVE_COMPARATOR: Educational-support group; 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.	Behavioral: Group-based Therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Measured at baseline, week 8, and Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessments using Ideal-Body Stereotype Scale-Revised	Evaluate the participants' perception of the ideal-body stereotype	Measured at baseline, week 8, and Month 6
Assessments using Satisfaction and Dissatisfaction with Body Parts Scale	Evaluate participants' level of satisfaction and dissatisfaction with specific parts of their bodies	Measured at baseline, week 8, and Month 6
Assessments using Dutch Restrained Eating Scale	Evaluate participants ability to exercise restraint in regards to food	Measured at baseline, week 8, and Month 6
Assessments using Positive Affect and Negative Affect Scale-Revised	Measure participants' affect and monitor any changes that may occur.	Measured at baseline, week 8, and Month 6
Assessments using Beliefs About Appearance Scale	Evaluate participants' perceptions and beliefs on physical appearance.	Measured at baseline, week 8, and Month 6

Collaborators and Investigators

• Sponsor: Oregon Research Institute
• Collaborators: National Institute of Mental Health (NIMH)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2012
• Primary Completion (ACTUAL): April 1, 2018
• Study Completion (ACTUAL): April 1, 2018

Study Registration Dates

• First Submitted: March 29, 2017
• First Submitted That Met QC Criteria: August 22, 2017
• First Posted (ACTUAL): August 23, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 2, 2018
• Last Update Submitted That Met QC Criteria: May 1, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Feeding and Eating Disorders
• Other Study ID Numbers: IndPrevPilot; 1R01MH086582-01A1 (NIH)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No