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Binge Eating Disorder Treatment Study

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00848367
Enrollment
102
Registered
2009-02-20
Start date
2007-04-30
Completion date
2011-12-31
Last updated
2014-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Binge Eating Disorder

Brief 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).

Interventions

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.

Sponsors

Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
Ottawa Hospital Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Frequency of Binge Eating in the Past 28 DaysPre and Post treatment, 6 months and 1 year

Secondary

MeasureTime frameDescription
Depression SymptomsPre 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.

Countries

Canada

Participant flow

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).

Participants by arm

ArmCount
High Attachment Anxiety Condition
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.
50
Low Attachment Anxiety Condition
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.
52
Total102

Baseline characteristics

CharacteristicLow Attachment Anxiety ConditionHigh Attachment Anxiety ConditionTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
3 Participants0 Participants3 Participants
Age, Categorical
Between 18 and 65 years
49 Participants50 Participants99 Participants
Age, Continuous46.23 years
STANDARD_DEVIATION 12.67
42.29 years
STANDARD_DEVIATION 10.54
44.32 years
STANDARD_DEVIATION 11.79
Region of Enrollment
Canada
52 participants50 participants102 participants
Sex: Female, Male
Female
52 Participants50 Participants102 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

Frequency of Binge Eating in the Past 28 Days

Time frame: Pre and Post treatment, 6 months and 1 year

ArmMeasureGroupValue (MEAN)Dispersion
High Attachment Anxiety ConditionFrequency of Binge Eating in the Past 28 DaysFreq. of binge eating in the Past 28 days: Pre16.06 daysStandard Deviation 6.57
High Attachment Anxiety ConditionFrequency of Binge Eating in the Past 28 DaysFreq. of binge eating in the Past 28 days: Post6.26 daysStandard Deviation 6.45
High Attachment Anxiety ConditionFrequency of Binge Eating in the Past 28 DaysFreq. of binge eating in the Past 28 days: 6mo6.40 daysStandard Deviation 8.66
High Attachment Anxiety ConditionFrequency of Binge Eating in the Past 28 DaysFreq. of binge eating in the Past 28 days: 12mo5.67 daysStandard Deviation 6.14
Low Attachment Anxiety ConditionFrequency of Binge Eating in the Past 28 DaysFreq. of binge eating in the Past 28 days: 12mo4.10 daysStandard Deviation 5.03
Low Attachment Anxiety ConditionFrequency of Binge Eating in the Past 28 DaysFreq. of binge eating in the Past 28 days: Pre14.48 daysStandard Deviation 4.69
Low Attachment Anxiety ConditionFrequency of Binge Eating in the Past 28 DaysFreq. of binge eating in the Past 28 days: 6mo6.56 daysStandard Deviation 8.49
Low Attachment Anxiety ConditionFrequency of Binge Eating in the Past 28 DaysFreq. of binge eating in the Past 28 days: Post7.40 daysStandard Deviation 8.18
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.

Time frame: Pre and Post treatment, 6 months and 1 year

ArmMeasureGroupValue (MEAN)Dispersion
High Attachment Anxiety ConditionDepression SymptomsDepression Symptoms: Post15.51 units on a scaleStandard Deviation 11.48
High Attachment Anxiety ConditionDepression SymptomsDepression Symptoms: 6 month12.62 units on a scaleStandard Deviation 9.52
High Attachment Anxiety ConditionDepression SymptomsDepression Symptoms: 12 month17.32 units on a scaleStandard Deviation 9.78
High Attachment Anxiety ConditionDepression SymptomsDepression Symptoms: Pre25.82 units on a scaleStandard Deviation 10.58
Low Attachment Anxiety ConditionDepression SymptomsDepression Symptoms: Pre16.42 units on a scaleStandard Deviation 10.49
Low Attachment Anxiety ConditionDepression SymptomsDepression Symptoms: Post10.26 units on a scaleStandard Deviation 8.31
Low Attachment Anxiety ConditionDepression SymptomsDepression Symptoms: 12 month9.75 units on a scaleStandard Deviation 10.26
Low Attachment Anxiety ConditionDepression SymptomsDepression Symptoms: 6 month8.30 units on a scaleStandard Deviation 7.08

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026