NCT03259347

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
534

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

March 29, 2017

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 23, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

May 2, 2018

Status Verified

May 1, 2018

Enrollment Period

5.8 years

First QC Date

March 29, 2017

Last Update Submit

May 1, 2018

Conditions

Body ImageEating Disorders

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Assessments using Ideal-Body Stereotype Scale-Revised

    Measured at baseline, week 8, and Month 6

  • Assessments using Satisfaction and Dissatisfaction with Body Parts Scale

    Measured at baseline, week 8, and Month 6

  • Assessments using Dutch Restrained Eating Scale

    Measured at baseline, week 8, and Month 6

  • Assessments using Positive Affect and Negative Affect Scale-Revised

    Measured at baseline, week 8, and Month 6

  • Assessments using Beliefs About Appearance Scale

    Measured at baseline, week 8, and Month 6

Study Arms (2)

Counter-attitudinal therapy

EXPERIMENTAL

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

Educational-support group

ACTIVE COMPARATOR

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

Interventions

Group-based TherapyBEHAVIORAL

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.

Counter-attitudinal therapyEducational-support group

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Oregon Research Institute

Eugene, Oregon, 97403, United States

Location

Drexel University

Philadelphia, Pennsylvania, 19104, United States

Location

The University of Texas

Austin, Texas, 78712, United States

Location

Related Publications (1)

  • 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.

    PMID: 30570303DERIVED

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2017

First Posted

August 23, 2017

Study Start

June 1, 2012

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

May 2, 2018

Record last verified: 2018-05

Locations

US(3)