Binge Eating DisorderPhase 1/2NCT01208272
Psychological Treatment of Overweight Binge Eaters
A Phase 1/2 study testing Cognitive Behavioral Therapy (CBT) and Interpersonal Therapy (IPT) in people with Binge Eating Disorder and Cognitive Therapy/Methods, run by Washington University School of Medicine at 2 sites in United States.
Trial summary
Cognitive-behavioral therapy (CBT) has documented efficacy for the treatment of binge eating disorder (BED). Interpersonal psychotherapy (IPT) has been shown to reduce binge eating but its long-term impact and time course on other BED-related symptoms remain largely unknown. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Binge Eating Disorder, Cognitive Therapy/Methods, Mental Disorders/Epidemiology
- What is being tested?
- Cognitive Behavioral Therapy (CBT) and Interpersonal Therapy (IPT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 1994to Mar 1999
- Phase
- Phase 1/2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- DSM-IV research criteria for binge-eating disorder
- Average of greater than or equal to 2 days of binge eating per week for at least 6 months' duration
- Marked stress regarding binge eating
- At least 3 to 5 associated behavioral features (e.g. eating when not physically hungry) Other study criteria
- 18-65 years old
- Body mass index, 27-48 kg/m squared
Who cannot join
- Pregnant or planning to become pregnant
- Taking weight-affecting or psychotropic medications
- Psychiatric conditions warranting immediate treatment
- Current enrollment in psychotherapy or a weight loss program
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Yale University
New Haaven, Connecticut, 06511-3516
Yale University
New Haven, Connecticut, 06511-3516
About this study
Official title: A Randomized Comparison of Group-Behavioral Therapy and Group Interpersonal Psychotherapy for the Treatment of Overweight Individuals With Binge-Eating Disorder
Cognitive-behavioral therapy (CBT) has documented efficacy for the treatment of binge eating disorder (BED). Interpersonal psychotherapy (IPT) has been shown to reduce binge eating but its long-term impact and time course on other BED-related symptoms remain largely unknown. This study compares the effects of group CBT and group IPT across BED-related symptoms among overweight individuals with BED.
Read the detailed description
Cognitive-behavioral therapy (CBT) has documented efficacy for the treatment of binge eating disorder (BED). Interpersonal psychotherapy (IPT) has been shown to reduce binge eating but its long-term impact and time course on other BED-related symptoms remain largely unknown. This study compares the effects of group CBT and group IPT across BED-related symptoms among overweight individuals with BED. METHODS: One hundred sixty-two overweight patients meeting DSM-IV criteria for BED were randomly assigned to 20 weekly sessions of either group CBT or group IPT. Assessments of binge eating and associated eating disorder psychopathology, general psychological functioning, and weight occurred before treatment, at posttreatment, and at 4-month intervals up to 12 months following treatment. RESULTS: Binge-eating recovery rates were equivalent for CBT and IPT at posttreatment (64 [79%] of 81 vs 59 [73%] of 81) and at 1-year follow-up (48 [59%] of 81 vs 50 [62%] of 81). Binge eating increased slightly through follow-up but remained significantly below pretreatment levels. Across treatments, patients had similar significant reductions in associated eating disorders and psychiatric symptoms and maintenance of gains through follow-up. Dietary restraint decreased more quickly in CBT but IPT had equivalent levels by later follow-ups. Patients' relative weight decreased significantly but only slightly, with the greatest reduction among patients sustaining recovery from binge eating from posttreatment to 1-year follow-up. CONCLUSIONS: Group IPT is a viable alternative to group CBT for the treatment of overweight patients with BED. Although lacking a nonspecific control condition limits conclusions about treatment specificity, both treatments showed initial and long-term efficacy for the core and related symptoms of BED.
- Conditions
- Binge Eating Disorder, Cognitive Therapy/Methods, Mental Disorders/Epidemiology, Obesity/Epidemiology, Obesity/Therapy
- Being tested
- Cognitive Behavioral Therapy (CBT), Interpersonal Therapy (IPT)
- Keywords
- Body Mass Index, Bulimia/therapy, Comorbidity, Interpersonal Relations, Psychotherapy/methods
- Medical subject headings
- Binge-Eating Disorder, Mental Disorders, Obesity, Bulimia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy (CBT)Behavioural
Interpersonal Therapy (IPT)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Binge Eating Disorder/Therapy | Experimental | Not described Receives: Behavioral: Cognitive Behavioral Therapy (CBT); Behavioral: Interpersonal Therapy (IPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the short and long-term efficacy of two treatments for binge eating among the overweight: Group Cognitive-Behavior (CBT) and Group Interpersonal Therapy (IPT).
Assessments of binge eating and associated eating disorder paychopathology, general psychological functioning, and weight occurred before treatment, at post treatment, and at 4-month intervals up to 12 months following treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2010 (estimated)
- Study startApr 1994
- Primary completionMar 1998
- Study completionMar 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Binge Eating DisorderStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Denise E Wilfley, Ph.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01208272
- Sponsor's protocol ID
- R29MH051384
- Status last verified
- Sep 2010
- First submitted
- 31 Aug 2010
- Last updated
- 23 Sep 2010
- Results posted
- No
Publications
Wilfley DE, Welch RR, Stein RI, Spurrell EB, Cohen LR, Saelens BE, Dounchis JZ, Frank MA, Wiseman CV, Matt GE. A randomized comparison of group cognitive-behavioral therapy and group interpersonal psychotherapy for the treatment of overweight individuals with binge-eating disorder. Arch Gen Psychiatry. 2002 Aug;59(8):713-21. doi: 10.1001/archpsyc.59.8.713.
PubMed 12150647Hilbert A, Bishop ME, Stein RI, Tanofsky-Kraff M, Swenson AK, Welch RR, Wilfley DE. Long-term efficacy of psychological treatments for binge eating disorder. Br J Psychiatry. 2012 Mar;200(3):232-7. doi: 10.1192/bjp.bp.110.089664. Epub 2012 Jan 26.
PubMed 22282429
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of Group-Behavioral Therapy and Group Interpersonal Psychotherapy for the Treatment of Overweight Individuals With Binge-Eating Disorder
- ClinicalTrials.gov ID
- NCT01208272
- Acronym / sponsor ID
- R29MH051384
- Conditions
- Binge Eating Disorder, Cognitive Therapy/Methods, Mental Disorders/Epidemiology, Obesity/Epidemiology, Obesity/Therapy
- Keywords
- Body Mass Index, Bulimia/therapy, Comorbidity, Interpersonal Relations, Psychotherapy/methods
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Apr 1994
- Primary completion
- Mar 1998 (actual)
- Study completion
- Mar 1999 (actual)
- First posted
- 23 Sep 2010 (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.
Cognitive-behavioral therapy (CBT) has documented efficacy for the treatment of binge eating disorder (BED). Interpersonal psychotherapy (IPT) has been shown to reduce binge eating but its long-term impact and time course on other BED-related symptoms remain largely unknown. This study compares the effects of group CBT and group IPT across BED-related symptoms among overweight individuals with BED.
Detailed description
Cognitive-behavioral therapy (CBT) has documented efficacy for the treatment of binge eating disorder (BED). Interpersonal psychotherapy (IPT) has been shown to reduce binge eating but its long-term impact and time course on other BED-related symptoms remain largely unknown. This study compares the effects of group CBT and group IPT across BED-related symptoms among overweight individuals with BED. METHODS: One hundred sixty-two overweight patients meeting DSM-IV criteria for BED were randomly assigned to 20 weekly sessions of either group CBT or group IPT. Assessments of binge eating and associated eating disorder psychopathology, general psychological functioning, and weight occurred before treatment, at posttreatment, and at 4-month intervals up to 12 months following treatment. RESULTS: Binge-eating recovery rates were equivalent for CBT and IPT at posttreatment (64 [79%] of 81 vs 59 [73%] of 81) and at 1-year follow-up (48 [59%] of 81 vs 50 [62%] of 81). Binge eating increased slightly through follow-up but remained significantly below pretreatment levels. Across treatments, patients had similar significant reductions in associated eating disorders and psychiatric symptoms and maintenance of gains through follow-up. Dietary restraint decreased more quickly in CBT but IPT had equivalent levels by later follow-ups. Patients' relative weight decreased significantly but only slightly, with the greatest reduction among patients sustaining recovery from binge eating from posttreatment to 1-year follow-up. CONCLUSIONS: Group IPT is a viable alternative to group CBT for the treatment of overweight patients with BED. Although lacking a nonspecific control condition limits conclusions about treatment specificity, both treatments showed initial and long-term efficacy for the core and related symptoms of BED.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Binge Eating Disorder/Therapy | Experimental | Behavioral: Cognitive Behavioral Therapy (CBT), Behavioral: Interpersonal Therapy (IPT) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- DSM-IV research criteria for binge-eating disorder
- Average of greater than or equal to 2 days of binge eating per week for at least 6 months' duration
- Marked stress regarding binge eating
- At least 3 to 5 associated behavioral features (e.g. eating when not physically hungry) Other study criteria
- 18-65 years old
Key exclusion criteria (4 listed)
- Pregnant or planning to become pregnant
- Taking weight-affecting or psychotropic medications
- Psychiatric conditions warranting immediate treatment
- Current enrollment in psychotherapy or a weight loss program
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 |
|---|---|---|
| Cognitive Behavioral Therapy (CBT) | Behavioural | Binge Eating Disorder/Therapy |
| Interpersonal Therapy (IPT) | Behavioural | Binge Eating Disorder/Therapy |
Primary outcome
To investigate the short and long-term efficacy of two treatments for binge eating among the overweight: Group Cognitive-Behavior (CBT) and Group Interpersonal Therapy (IPT).
Assessments of binge eating and associated eating disorder paychopathology, general psychological functioning, and weight occurred before treatment, at post treatment, and at 4-month intervals up to 12 months following treatment.
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 23 Sep 2010.
- Results publication: PubMed 12150647Wilfley DE, Welch RR, Stein RI, Spurrell EB, Cohen LR, Saelens BE, Dounchis JZ, Frank MA, Wiseman CV, Matt GE. A randomized comparison of group cognitive-behavioral therapy and group interpersonal psychotherapy for the treatment of overweight individuals with binge-eating disorder. Arch Gen Psychiatry. 2002 Aug;59(8):713-21. doi: 10.1001/archpsyc.59.8.713.
- Derived from this study: PubMed 22282429Hilbert A, Bishop ME, Stein RI, Tanofsky-Kraff M, Swenson AK, Welch RR, Wilfley DE. Long-term efficacy of psychological treatments for binge eating disorder. Br J Psychiatry. 2012 Mar;200(3):232-7. doi: 10.1192/bjp.bp.110.089664. Epub 2012 Jan 26.
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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.
Denise E Wilfley, Ph.D. principal investigator
Washington University School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cognitive Behavioral Therapy (CBT) and Interpersonal Therapy (IPT) in people with Binge Eating Disorder and Cognitive Therapy/Methods, run by Washington University School of Medicine at 2 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 6 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 23 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To investigate the short and long-term efficacy of two treatments for binge eating among the overweight: Group Cognitive-Behavior (CBT) and Group Interpersonal Therapy (IPT).. 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 NCT01208272, which also lists 2 linked publications.
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 23 Sep 2010.