- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00848367
Binge Eating Disorder Treatment Study
January 10, 2014 updated by: Ottawa Hospital Research Institute
Optimizing Outcomes for Binge Eating, Depression and Weight Loss for Obese Women With Binge Eating Disorder by Matching to Group Psychological Treatments Based on Level of Attachment Anxiety
The main objective of the proposed study is to determine whether the effectiveness of a group therapy treatment for Binge Eating Disorder (BED) is improved and attrition reduced by optimally matching women with BED who have high attachment anxiety to Group Psychodynamic Interpersonal Psychotherapy (GPIP).
This study represents the next phase in a program of research stemming from a previously conducted randomized controlled trial (RCT).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
102
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Ontario
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Ottawa, Ontario, Canada, K1H 8L6
- Regional Centre for the Treatment of Eating Disorders
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
•Overweight Women 18 years of age or older who binge eat at least twice per week for the past month.
Exclusion Criteria:
- unable speak English
- history of an eating disorder other than Binge Eating Disorder
- concurrent Diagnostic and Statistical Manual-IV (DSM-IV) diagnosis of bipolar disorder, psychosis, drug or alcohol problem
- pregnant or planning on becoming pregnant within the next year
- are currently or plan to become enrolled in a weight loss program within the next year
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: High attachment anxiety condition
16 weeks of Group Psychodynamic Interpersonal Psychotherapy for patients with Binge Eating Disorder, matching them by attachment anxiety dimensions in order to enhance the impact of the therapy.
It is hypothesized that by optimally matching patients to groups, they will have better clinical and health outcomes.
|
This intervention will consist of 16 weekly 90 minute sessions of Group Psychodynamic Interpersonal Psychotherapy (GPIP).
GPIP was developed and empirically tested in a randomized controlled trial (RCT) at our Centre.
GPIP will be preceded by an individual pre-group preparation session conducted by a psychologist trained in GPIP to orient the patient to the therapy.
Patients are given a rationale for the treatment.
|
EXPERIMENTAL: Low attachment anxiety condition
16 weeks of Group Psychodynamic Interpersonal Psychotherapy for patients with Binge Eating Disorder, matching them by attachment anxiety dimensions in order to enhance the impact of the therapy.
It is hypothesized that by optimally matching patients to groups, they will have better clinical and health outcomes.
|
This intervention will consist of 16 weekly 90 minute sessions of Group Psychodynamic Interpersonal Psychotherapy (GPIP).
GPIP was developed and empirically tested in a randomized controlled trial (RCT) at our Centre.
GPIP will be preceded by an individual pre-group preparation session conducted by a psychologist trained in GPIP to orient the patient to the therapy.
Patients are given a rationale for the treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Frequency of Binge Eating in the Past 28 Days
Time Frame: Pre and Post treatment, 6 months and 1 year
|
Pre and Post treatment, 6 months and 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression Symptoms
Time Frame: Pre and Post treatment, 6 months and 1 year
|
Early response to treatment is indicated by a reduction in depression symptoms measured by The Beck Depression Inventory II (BDI-II; Beck, Steer, & Brown, 1996).
The BDI-II is scored by summing the ratings for the 21 items.
Each item is rated on a 4-point scale ranging from 0 to 3. The range for this scale is 0-63.
Higher scores represent more depressive symptoms.
We included cases that were missing up to 8 missing items and calculated scores for participants with missing items by taking the weighted mean and multiplying by 21.
|
Pre and Post treatment, 6 months and 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Giorgio Tasca, Ph.D.C.Psych, University of Ottawa, Ottawa Hospital-General Campus
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2007
Primary Completion (ACTUAL)
September 1, 2010
Study Completion (ACTUAL)
December 1, 2011
Study Registration Dates
First Submitted
February 19, 2009
First Submitted That Met QC Criteria
February 19, 2009
First Posted (ESTIMATE)
February 20, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
February 7, 2014
Last Update Submitted That Met QC Criteria
January 10, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2007254-01H
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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