Trial Outcomes & Findings for Binge Eating Disorder Treatment Study (NCT NCT00848367)
NCT ID: NCT00848367
Last Updated: 2014-02-07
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
102 participants
Primary outcome timeframe
Pre and Post treatment, 6 months and 1 year
Results posted on
2014-02-07
Participant Flow
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).
Participant milestones
| Measure |
Low Attachment Anxiety Condition
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.
|
High Attachment Anxiety Condition
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.
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|---|---|---|
|
Overall Study
STARTED
|
52
|
50
|
|
Overall Study
COMPLETED
|
43
|
41
|
|
Overall Study
NOT COMPLETED
|
9
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Binge Eating Disorder Treatment Study
Baseline characteristics by cohort
| Measure |
High Attachment Anxiety Condition
n=50 Participants
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.
|
Low Attachment Anxiety Condition
n=52 Participants
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
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
50 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
42.29 years
STANDARD_DEVIATION 10.54 • n=5 Participants
|
46.23 years
STANDARD_DEVIATION 12.67 • n=7 Participants
|
44.32 years
STANDARD_DEVIATION 11.79 • n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
50 participants
n=5 Participants
|
52 participants
n=7 Participants
|
102 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre and Post treatment, 6 months and 1 yearOutcome measures
| Measure |
High Attachment Anxiety Condition
n=41 Participants
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.
|
Low Attachment Anxiety Condition
n=43 Participants
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.
|
|---|---|---|
|
Frequency of Binge Eating in the Past 28 Days
Freq. of binge eating in the Past 28 days: 6mo
|
6.40 days
Standard Deviation 8.66
|
6.56 days
Standard Deviation 8.49
|
|
Frequency of Binge Eating in the Past 28 Days
Freq. of binge eating in the Past 28 days: 12mo
|
5.67 days
Standard Deviation 6.14
|
4.10 days
Standard Deviation 5.03
|
|
Frequency of Binge Eating in the Past 28 Days
Freq. of binge eating in the Past 28 days: Pre
|
16.06 days
Standard Deviation 6.57
|
14.48 days
Standard Deviation 4.69
|
|
Frequency of Binge Eating in the Past 28 Days
Freq. of binge eating in the Past 28 days: Post
|
6.26 days
Standard Deviation 6.45
|
7.40 days
Standard Deviation 8.18
|
SECONDARY outcome
Timeframe: Pre and Post treatment, 6 months and 1 yearEarly 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.
Outcome measures
| Measure |
High Attachment Anxiety Condition
n=50 Participants
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.
|
Low Attachment Anxiety Condition
n=52 Participants
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.
|
|---|---|---|
|
Depression Symptoms
Depression Symptoms: Pre
|
25.82 units on a scale
Standard Deviation 10.58
|
16.42 units on a scale
Standard Deviation 10.49
|
|
Depression Symptoms
Depression Symptoms: Post
|
15.51 units on a scale
Standard Deviation 11.48
|
10.26 units on a scale
Standard Deviation 8.31
|
|
Depression Symptoms
Depression Symptoms: 6 month
|
12.62 units on a scale
Standard Deviation 9.52
|
8.30 units on a scale
Standard Deviation 7.08
|
|
Depression Symptoms
Depression Symptoms: 12 month
|
17.32 units on a scale
Standard Deviation 9.78
|
9.75 units on a scale
Standard Deviation 10.26
|
Adverse Events
High Attachment Anxiety Condition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Low Attachment Anxiety Condition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place