CClinicalTrials.gg
CompletedNCT03259347Updated May 2, 2018

Eating Disorders Programs: An Indicated Trial

An interventional study of Group-based Therapy in Body Image and Eating Disorders, sponsored by Oregon Research Institute. Completed at 3 sites in United States. Open to female participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-02.

Sponsored by Oregon Research Institute · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
534
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Body Image
  • Eating Disorders
03

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
534 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • BehavioralGroup-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.

05

What researchers measure

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.

    Time frame: Measured at baseline, week 8, and Month 6

Secondary outcomes

  1. Assessments using Ideal-Body Stereotype Scale-Revised

    Evaluate the participants' perception of the ideal-body stereotype

    Time frame: Measured at baseline, week 8, and Month 6

  2. Assessments using Satisfaction and Dissatisfaction with Body Parts Scale

    Evaluate participants' level of satisfaction and dissatisfaction with specific parts of their bodies

    Time frame: Measured at baseline, week 8, and Month 6

  3. Assessments using Dutch Restrained Eating Scale

    Evaluate participants ability to exercise restraint in regards to food

    Time frame: Measured at baseline, week 8, and Month 6

  4. Assessments using Positive Affect and Negative Affect Scale-Revised

    Measure participants' affect and monitor any changes that may occur.

    Time frame: Measured at baseline, week 8, and Month 6

  5. Assessments using Beliefs About Appearance Scale

    Evaluate participants' perceptions and beliefs on physical appearance.

    Time frame: Measured at baseline, week 8, and Month 6

06

Study locations

3 sites
  • Oregon Research Institute
    Eugene, Oregon 97403, United States
  • Drexel University
    Philadelphia, Pennsylvania 19104, United States
  • The University of Texas
    Austin, Texas 78712, United States
07

References and documents

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. PubMed 30570303 ↗
08

Registry details

Key details

Study ID
NCT03259347
Lead sponsor
Oregon Research Institute
Collaborators
National Institute of Mental Health (NIMH)
Responsible party
Sponsor
First posted
Aug 23, 2017
Start date
Jun 1, 2012
Primary completion
Apr 1, 2018
Completion
Apr 1, 2018
Last update
May 2, 2018

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion