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Binge Eating Disorder Treatment Study

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ClinicalTrials.gov Identifier: NCT00848367
Recruitment Status : Completed
First Posted : February 20, 2009
Results First Posted : December 11, 2013
Last Update Posted : February 7, 2014
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Binge Eating Disorder
Intervention Behavioral: Group Psychodynamic Interpersonal Psychotherapy
Enrollment 102
Recruitment Details Participants were self-referred from advertisements distributed around Ottawa and surrounding area, or referred from the Regional Center for the Treatment of Eating Disorders at The Ottawa Hospital (Sept. 2007 to Mar.2009).
Pre-assignment Details  
Arm/Group Title Low Attachment Anxiety Condition High Attachment Anxiety Condition
Hide Arm/Group Description In our study sample, the range of scores for the Need for Approval subscale of the Attachment Style Questionnaire was 1.86-5.71 (the possible range of this subscale is 1-7). Participants in this group scored lower than the cut off of 3.59 on the Need for Approval subscale of the Attachment Style questionnaire. They were assigned to therapy groups homogeneously composed of participants with low attachment anxiety (i.e. others that scored below the cut off). The type of therapy administered to this group was Group Psychodynamic Interpersonal Psychotherapy (GPIP; Tasca, G., Mikail, S. & Hewitt, P. Group Psychodynamic Interpersonal Psychotherapy: A Manual for Time Limited Treatment of Binge Eating Disorder. (2002).) Participants received 16 weekly 90 minute sessions of GPIP from a male or female therapist. In our study sample, the range of scores for the Need for Approval subscale of the Attachment Style Questionnaire was 1.86-5.71 (the possible range of this subscale is 1-7). Participants in this group scored greater than the cut off of 3.59 on the Need for Approval subscale of the Attachment Style questionnaire. They were assigned to therapy groups homogeneously composed of participants with high attachment anxiety (i.e. others that scored above the cut off). The type of therapy provided was called Group Psychodynamic Interpersonal Psychotherapy (GPIP; Tasca, G., Mikail, S. & Hewitt, P. Group Psychodynamic Interpersonal Psychotherapy: A Manual for Time Limited Treatment of Binge Eating Disorder. (2002).) Participants received 16 weekly 90 minute sessions of GPIP from a male or female therapist.
Period Title: Overall Study
Started 52 50
Completed 43 41
Not Completed 9 9
Arm/Group Title High Attachment Anxiety Condition Low Attachment Anxiety Condition Total
Hide Arm/Group Description These participants scored greater than the cut off of 3.59 on the Need for Approval subscale of the Attachment Style questionnaire. They were assigned to therapy groups homogeneously composed of participants with high attachment anxiety. These participants scored lower than the cut off of 3.59 on the Need for Approval subscale of the Attachment Style questionnaire. They were assigned to therapy groups homogeneously composed of participants with low attachment anxiety. Total of all reporting groups
Overall Number of Baseline Participants 50 52 102
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 52 participants 102 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
50
 100.0%
49
  94.2%
99
  97.1%
>=65 years
0
   0.0%
3
   5.8%
3
   2.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 52 participants 102 participants
42.29  (10.54) 46.23  (12.67) 44.32  (11.79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 52 participants 102 participants
Female
50
 100.0%
52
 100.0%
102
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 50 participants 52 participants 102 participants
50 52 102
1.Primary Outcome
Title Frequency of Binge Eating in the Past 28 Days
Hide Description [Not Specified]
Time Frame Pre and Post treatment, 6 months and 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Attachment Anxiety Condition Low Attachment Anxiety Condition
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 41 43
Mean (Standard Deviation)
Unit of Measure: days
Freq. of binge eating in the Past 28 days: Pre 16.06  (6.57) 14.48  (4.69)
Freq. of binge eating in the Past 28 days: Post 6.26  (6.45) 7.40  (8.18)
Freq. of binge eating in the Past 28 days: 6mo 6.40  (8.66) 6.56  (8.49)
Freq. of binge eating in the Past 28 days: 12mo 5.67  (6.14) 4.10  (5.03)
2.Secondary Outcome
Title Depression Symptoms
Hide Description 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.
Time Frame Pre and Post treatment, 6 months and 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Attachment Anxiety Condition Low Attachment Anxiety Condition
Hide Arm/Group Description:
These participants scored greater than the cut off of 3.59 on the Need for Approval subscale of the Attachment Style questionnaire. They were assigned to therapy groups homogeneously composed of participants with high attachment anxiety.
These participants scored lower than the cut off of 3.59 on the Need for Approval subscale of the Attachment Style questionnaire. They were assigned to therapy groups homogeneously composed of participants with low attachment anxiety.
Overall Number of Participants Analyzed 50 52
Mean (Standard Deviation)
Unit of Measure: units on a scale
Depression Symptoms: Pre 25.82  (10.58) 16.42  (10.49)
Depression Symptoms: Post 15.51  (11.48) 10.26  (8.31)
Depression Symptoms: 6 month 12.62  (9.52) 8.30  (7.08)
Depression Symptoms: 12 month 17.32  (9.78) 9.75  (10.26)
Time Frame [Not Specified]
Adverse Event Reporting Description We have written 0 as the Total Number of Participants at Risk since the trial consists of group therapy to which there are no risks associated.
 
Arm/Group Title High Attachment Anxiety Condition Low Attachment Anxiety Condition
Hide Arm/Group Description 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. 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.
All-Cause Mortality
High Attachment Anxiety Condition Low Attachment Anxiety Condition
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
High Attachment Anxiety Condition Low Attachment Anxiety Condition
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
High Attachment Anxiety Condition Low Attachment Anxiety Condition
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Giorgio Tasca
Organization: Ottawa Hospital Research Institute
Phone: 1-613-737-8085
Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00848367     History of Changes
Other Study ID Numbers: 2007254-01H
First Submitted: February 19, 2009
First Posted: February 20, 2009
Results First Submitted: June 4, 2013
Results First Posted: December 11, 2013
Last Update Posted: February 7, 2014