Eating Disorders Programs: An Indicated Trial

Study Overview
=================
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.

Official Title
-----------------
Eating Disorders Programs: An Indicated Trial

Conditions
-----------------
Body Image, Eating Disorders

Intervention / Treatment
-----------------
* Behavioral: Group-based Therapy


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Counter-attitudinal therapy<br>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<br>* 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.<br>|
| Active Comparator: Educational-support group<br>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<br>* 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.<br>|

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 |