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Eating Disorders Programs: An Indicated Trial

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ClinicalTrials.gov Identifier: NCT03259347
Recruitment Status : Active, not recruiting
First Posted : August 23, 2017
Last Update Posted : August 23, 2017
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Oregon Research Institute

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.

Condition or disease Intervention/treatment Phase
Body Image Eating Disorders Behavioral: Group-based Therapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 534 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Eating Disorders Programs: An Indicated Trial
Actual Study Start Date : June 1, 2012
Estimated Primary Completion Date : April 1, 2018
Estimated Study Completion Date : April 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders
U.S. FDA Resources

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.



Primary Outcome Measures :
  1. Change from Baseline Eating Disorder Diagnostic responses using the Eating Disorder Examination questionnaire at 8 weeks and 6 months [ Time Frame: Measured at baseline, week 8, and Month 6 ]
    Evaluate change (if any) by using the Eating Disorder Examination questionnaire at the 8 week and 6 month mark.


Secondary Outcome Measures :
  1. Assessments using Ideal-Body Stereotype Scale-Revised [ Time Frame: Measured at baseline, week 8, and Month 6 ]
    Evaluate the participants' perception of the ideal-body stereotype

  2. Assessments using Satisfaction and Dissatisfaction with Body Parts Scale [ Time Frame: Measured at baseline, week 8, and Month 6 ]
    Evaluate participants' level of satisfaction and dissatisfaction with specific parts of their bodies

  3. Assessments using Dutch Restrained Eating Scale [ Time Frame: Measured at baseline, week 8, and Month 6 ]
    Evaluate participants ability to exercise restraint in regards to food

  4. Assessments using Positive Affect and Negative Affect Scale-Revised [ Time Frame: Measured at baseline, week 8, and Month 6 ]
    Measure participants' affect and monitor any changes that may occur.

  5. Assessments using Beliefs About Appearance Scale [ Time Frame: Measured at baseline, week 8, and Month 6 ]
    Evaluate participants' perceptions and beliefs on physical appearance.



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03259347


Locations
United States, Oregon
Oregon Research Institute
Eugene, Oregon, United States, 97403
United States, Pennsylvania
Drexel University
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
The University of Texas
Austin, Texas, United States, 78712
Sponsors and Collaborators
Oregon Research Institute
National Institute of Mental Health (NIMH)

Responsible Party: Oregon Research Institute
ClinicalTrials.gov Identifier: NCT03259347     History of Changes
Other Study ID Numbers: IndPrevPilot
1R01MH086582-01A1 ( U.S. NIH Grant/Contract )
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: August 23, 2017
Last Verified: August 2017

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

Additional relevant MeSH terms:
Disease
Feeding and Eating Disorders
Pathologic Processes
Mental Disorders