Body ImageNCT03259347
Eating Disorders Programs: An Indicated Trial
A study testing Group-based Therapy in people with Body Image and Eating Disorders, run by Oregon Research Institute at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Body Image, Eating Disorders
- What is being tested?
- Group-based Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 534 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jun 2012to 1 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant indicates sub-threshold or threshold eating disorder.
- Participant is available to participate in the intervention sessions.
- Participants must be MRI eligible.
Who cannot join
- Participant does not indicate sub-threshold or threshold eating disorder.
- Participant is unable to attend intervention sessions.
- Participant cannot participate if MRI ineligible.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The University of Texas
Austin, Texas, 78712
Oregon Research Institute
Eugene, Oregon, 97403
Drexel University
Philadelphia, Pennsylvania, 19104
About this study
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.
- Conditions
- Body Image, Eating Disorders
- Being tested
- Group-based Therapy
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group-based TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Group-based Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at baseline, week 8, and Month 6
Secondary outcomes (5)
Assessments using Ideal-Body Stereotype Scale-Revised
Evaluate the participants' perception of the ideal-body stereotype
Measured: 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: 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: 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: Measured at baseline, week 8, and Month 6
Assessments using Beliefs About Appearance Scale
Evaluate participants' perceptions and beliefs on physical appearance.
Measured: Measured at baseline, week 8, and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2017
- Study start1 Jun 2012
- Primary completion1 Apr 2018
- Study completion1 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Body ImageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 534 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03259347
- Sponsor's protocol ID
- IndPrevPilot
- Other IDs
- 1R01MH086582-01A1
- Status last verified
- May 2018
- First submitted
- 29 Mar 2017
- Last updated
- 2 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eating Disorders Programs: An Indicated Trial
- ClinicalTrials.gov ID
- NCT03259347
- Acronym / sponsor ID
- IndPrevPilot
- Conditions
- Body Image, Eating Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 534 participants (estimated)
- Lead sponsor
- Oregon Research InstituteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Jun 2012 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 1 Apr 2018 (actual)
- First posted
- 23 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Counter-attitudinal therapy | Experimental | Behavioral: Group-based TherapyCounter-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. |
| Educational-support group | Active comparator | Behavioral: Group-based TherapyThe 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participant indicates sub-threshold or threshold eating disorder.
- Participant is available to participate in the intervention sessions.
- Participants must be MRI eligible.
Key exclusion criteria (3 listed)
- Participant does not indicate sub-threshold or threshold eating disorder.
- Participant is unable to attend intervention sessions.
- Participant cannot participate if MRI ineligible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group-based TherapyYoung 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. | Behavioural | Counter-attitudinal therapy, Educational-support group |
Primary outcome
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.
5 secondary outcomes
Assessments using Ideal-Body Stereotype Scale-Revised
Time frame: Measured at baseline, week 8, and Month 6
Assessments using Satisfaction and Dissatisfaction with Body Parts Scale
Time frame: Measured at baseline, week 8, and Month 6
Assessments using Dutch Restrained Eating Scale
Time frame: Measured at baseline, week 8, and Month 6
Assessments using Positive Affect and Negative Affect Scale-Revised
Time frame: Measured at baseline, week 8, and Month 6
Assessments using Beliefs About Appearance Scale
Time frame: Measured at baseline, week 8, and Month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2018.
- Derived from this study: PubMed 30570303Stice 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group-based Therapy in people with Body Image and Eating Disorders, run by Oregon Research Institute at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03259347, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2018.