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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00848367
Other study ID # 2007254-01H
Secondary ID
Status Completed
Phase N/A
First received February 19, 2009
Last updated January 10, 2014
Start date April 2007
Est. completion date December 2011

Study information

Verified date January 2014
Source Ottawa Hospital Research Institute
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Completed
Enrollment 102
Est. completion date December 2011
Est. primary completion date September 2010
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Intervention

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.

Locations

Country Name City State
Canada Regional Centre for the Treatment of Eating Disorders Ottawa Ontario

Sponsors (2)

Lead Sponsor Collaborator
Ottawa Hospital Research Institute Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Tasca GA, Ritchie K, Demidenko N, Balfour L, Krysanski V, Weekes K, Barber A, Keating L, Bissada H. Matching women with binge eating disorder to group treatment based on attachment anxiety: outcomes and moderating effects. Psychother Res. 2013;23(3):301-1 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency of Binge Eating in the Past 28 Days Pre and Post treatment, 6 months and 1 year No
Secondary Depression Symptoms 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 No
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