Eating DisordersPhase 4NCT00060762
Effectiveness of Binge Eating Disorder Treatments
A Phase 4 study testing Interpersonal Therapy, Behavioral Weight Loss Treatment and Guided Self Help in people with Eating Disorders, run by Stanford University at 3 sites in United States.
Trial summary
This study will evaluate the long-term effectiveness of interpersonal psychotherapy, behavioral weight loss interventions, and guided self help treatments in treating binge eating disorder (BED). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Eating Disorders
- What is being tested?
- Interpersonal Therapy, Behavioral Weight Loss Treatment and Guided Self Help
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2002to Mar 2007
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DSM-IV criteria for Binge Eating Disorder
- Body Mass Index (BMI) between 27 and 45
Who cannot join
- Body Mass index > 45
- Current psychosis
- Current bipolar disorder
- Alcohol or drug dependence within last 6-months
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Rutgers University Eating Disorder Clinic
Piscataway, New Jersey, 08854
Washington University School of Medicine
St Louis, Missouri, 63100
W. Stewart Agras
Stanford, California, 94305
About this study
Official title: Effectiveness of Psychological Treatments for BED
This study will evaluate the long-term effectiveness of interpersonal psychotherapy, behavioral weight loss interventions, and guided self help treatments in treating binge eating disorder (BED).
Read the detailed description
BED is a serious condition that is associated with psychiatric comorbidity, psychosocial impairment, and obesity. Interpersonal psychotherapy (IPT), behavioral weight loss (BWL) interventions, and guided self help (GSH) treatments for BED have been evaluated, but the safest and most effective treatment has not yet been identified. This study will determine which of these three treatments is most effective in treating BED.
Participants are stratified by negative affect subtype and are randomly assigned for 6 months to one of three treatment groups: IPT, BWL, or GSH. IPT focuses on current interpersonal problems which are hypothesized to increase negative affect and lead to binge eating. BWL interventions involve the adoption of weight loss inducing behaviors. GSH is a shortened version of cognitive behavioral therapy that focuses directly on eating behavior. IPT and BWL patients have 20 treatment sessions; those receiving GSH have 10 sessions. Assessments are made pre-treatment, post-treatment, and at 6, 12, 18, and 24 months after treatment is complete.
- Conditions
- Eating Disorders
- Being tested
- Interpersonal Therapy, Behavioral Weight Loss Treatment, Guided Self Help
- Keywords
- Weight Loss
- Medical subject headings
- Feeding and Eating Disorders, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpersonal TherapyBehavioural
Also called IPT
20 sessions of interpersonal therapy were provided over a 6-month period
Behavioral Weight Loss TreatmentBehavioural
Also called BWL; Weight loss treatment
20 sessions of behavioral weight loss treatment were provided over a 6-month period
Guided Self HelpBehavioural
Also called GSH
10 sessions of guided self help were provided over a 6-month period
| Study group | Role | What they receive |
|---|---|---|
| Interpersonal Therapy | Experimental | Interpersonal Therapy is a psychotherapy aimed at resolving interpersonal difficulties Receives: Behavioral: Interpersonal Therapy |
| Behavioral Weight Loss Treatment | Active comparator | Behavioral Weight Loss Treatment is aimed solely at weight loss, however it has been shown to decrease binge eating Receives: Behavioral: Behavioral Weight Loss Treatment |
| Guided Self Help | Active comparator | Guided Self-Help is a brief psychotherapy based on cognitive-behavioral treatment Receives: Behavioral: Guided Self Help |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binge eating
Rate of binge eating
Measured: Pre-treatment, 6, 12, and 24-months
Secondary outcomes (1)
Eating disorder psychopathology
Assessed by the Eating Disorder Examination
Measured: pre-treatment, 6, 12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2003 (estimated)
- Study startApr 2002
- Primary completionMar 2007
- Study completionMar 2007
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 Eating DisordersStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- William S Agras, MD, Study director, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00060762
- Sponsor's protocol ID
- R01MH063863
- Other IDs
- R01MH063863, DSIR 83-ATAS
- Status last verified
- May 2014
- First submitted
- 12 May 2003
- Last updated
- 15 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wilson GT, Wilfley DE, Agras WS, Bryson SW. Psychological treatments of binge eating disorder. Arch Gen Psychiatry. 2010 Jan;67(1):94-101. doi: 10.1001/archgenpsychiatry.2009.170.
PubMed 20048227
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Psychological Treatments for BED
- ClinicalTrials.gov ID
- NCT00060762
- Acronym / sponsor ID
- R01MH063863
- Conditions
- Eating Disorders
- Keywords
- Weight Loss
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Apr 2002
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 13 May 2003 (estimated)
- 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.
This study will evaluate the long-term effectiveness of interpersonal psychotherapy, behavioral weight loss interventions, and guided self help treatments in treating binge eating disorder (BED).
Detailed description
BED is a serious condition that is associated with psychiatric comorbidity, psychosocial impairment, and obesity. Interpersonal psychotherapy (IPT), behavioral weight loss (BWL) interventions, and guided self help (GSH) treatments for BED have been evaluated, but the safest and most effective treatment has not yet been identified. This study will determine which of these three treatments is most effective in treating BED.
Participants are stratified by negative affect subtype and are randomly assigned for 6 months to one of three treatment groups: IPT, BWL, or GSH. IPT focuses on current interpersonal problems which are hypothesized to increase negative affect and lead to binge eating. BWL interventions involve the adoption of weight loss inducing behaviors. GSH is a shortened version of cognitive behavioral therapy that focuses directly on eating behavior. IPT and BWL patients have 20 treatment sessions; those receiving GSH have 10 sessions. Assessments are made pre-treatment, post-treatment, and at 6, 12, 18, and 24 months after treatment is complete.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Interpersonal Therapy | Experimental | Behavioral: Interpersonal TherapyInterpersonal Therapy is a psychotherapy aimed at resolving interpersonal difficulties |
| Behavioral Weight Loss Treatment | Active comparator | Behavioral: Behavioral Weight Loss TreatmentBehavioral Weight Loss Treatment is aimed solely at weight loss, however it has been shown to decrease binge eating |
| Guided Self Help | Active comparator | Behavioral: Guided Self HelpGuided Self-Help is a brief psychotherapy based on cognitive-behavioral treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- DSM-IV criteria for Binge Eating Disorder
- Body Mass Index (BMI) between 27 and 45
Key exclusion criteria (4 listed)
- Body Mass index > 45
- Current psychosis
- Current bipolar disorder
- Alcohol or drug dependence within last 6-months
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 |
|---|---|---|
| Interpersonal TherapyAlso: IPT20 sessions of interpersonal therapy were provided over a 6-month period | Behavioural | Interpersonal Therapy |
| Behavioral Weight Loss TreatmentAlso: BWL; Weight loss treatment20 sessions of behavioral weight loss treatment were provided over a 6-month period | Behavioural | Behavioral Weight Loss Treatment |
| Guided Self HelpAlso: GSH10 sessions of guided self help were provided over a 6-month period | Behavioural | Guided Self Help |
Primary outcome
Binge eating
Time frame: Pre-treatment, 6, 12, and 24-months
Rate of binge eating
1 secondary outcome
Eating disorder psychopathology
Time frame: pre-treatment, 6, 12, 24 months
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 15 May 2014.
- Results publication: PubMed 20048227Wilson GT, Wilfley DE, Agras WS, Bryson SW. Psychological treatments of binge eating disorder. Arch Gen Psychiatry. 2010 Jan;67(1):94-101. doi: 10.1001/archgenpsychiatry.2009.170.
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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.
William S Agras, MD study director
Stanford University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Interpersonal Therapy, Behavioral Weight Loss Treatment and Guided Self Help in people with Eating Disorders, run by Stanford University 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 2 inclusion and 4 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 15 May 2014. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Binge eating (time frame: Pre-treatment, 6, 12, and 24-months). 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 NCT00060762, 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 15 May 2014.