Focused Versus Enhanced Cognitive Behavioral Therapy for Treating Women With Bulimia Nervosa
Treatment of Bulimia Nervosa: Dysregulated Subtype
2 other identifiers
interventional
50
1 country
1
Brief Summary
This study will compare the effectiveness of two types of cognitive behavioral therapy in treating adult women with the dysregulated subtype of bulimia nervosa.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2007
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2007
CompletedStudy Start
First participant enrolled
July 1, 2007
CompletedFirst Posted
Study publicly available on registry
July 2, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedJuly 20, 2016
July 1, 2016
5.4 years
June 28, 2007
July 18, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Eating disorder symptoms
Measured throughout the study
Secondary Outcomes (3)
Depression symptoms
Measured throughout the study
Anxiety symptoms
Measured throughout the study
Interpersonal relationships
Measured throughout the study
Study Arms (2)
CBT-EF
ACTIVE COMPARATORParticipants will receive cognitive behavioral therapy - focused
CBT-EB
EXPERIMENTALParticipants will receive cognitive behavioral therapy - broad
Interventions
Focused CBT concentrates only on BN symptoms. There will be 20 sessions over the course of 5 months.
Broad CBT addresses symptoms of BN, as well as those of the personality disorder. CBT-EB incorporates ED interventions from CBT-EF but also has modules focused on addressing mood intolerance and interpersonal difficulties. There will be 20 sessions over 5 months.
Eligibility Criteria
You may qualify if:
- Diagnosis of bulimia nervosa
- Presence of borderline personality disorder features
- History of one mood or anxiety episode within 2 years prior to study entry
- If taking psychiatric medication, dose has been stable for at least 6 weeks at time of study entry
You may not qualify if:
- Substance dependence
- Diagnosis of bipolar I disorder
- Psychosis
- Mental retardation
- Receiving psychosocial treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boston Universitylead
- National Institute of Mental Health (NIMH)collaborator
Study Sites (1)
Center for Anxiety and Related Disorders, Boston University
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Heather Thompson-Brenner, PhD
Center for Anxiety and Related Disorders, Boston University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2007
First Posted
July 2, 2007
Study Start
July 1, 2007
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
July 20, 2016
Record last verified: 2016-07