Binge Eating Disorder Treatment Study

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00848367
First received: February 19, 2009
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

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).


Condition Intervention
Binge Eating Disorder
Behavioral: Group Psychodynamic Interpersonal Psychotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Frequency of Binge Eating in the Past 28 Days [ Time Frame: Pre and Post treatment, 6 months and 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Depression Symptoms [ Time Frame: Pre and Post treatment, 6 months and 1 year ] [ Designated as safety issue: No ]
    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.


Enrollment: 102
Study Start Date: April 2007
Study Completion Date: December 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: Group Psychodynamic Interpersonal Psychotherapy
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.
Behavioral: Group Psychodynamic Interpersonal Psychotherapy
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00848367

Locations
Canada, Ontario
Regional Centre for the Treatment of Eating Disorders
Ottawa, Ontario, Canada, K1H 8L6
Sponsors and Collaborators
Ottawa Hospital Research Institute
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Giorgio Tasca, Ph.D.C.Psych University of Ottawa, Ottawa Hospital-General Campus
  More Information

Additional Information:
Publications:
Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00848367     History of Changes
Other Study ID Numbers: 2007254-01H
Study First Received: February 19, 2009
Results First Received: June 4, 2013
Last Updated: January 10, 2014
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Binge-Eating Disorder
Bulimia
Disease
Eating Disorders
Hyperphagia
Mental Disorders
Pathologic Processes
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on October 21, 2014