Focused Versus Enhanced Cognitive Behavioral Therapy for Treating Women With Bulimia Nervosa
Treatment of Bulimia Nervosa: Dysregulated Subtype
Study Overview
Status
Conditions
Detailed Description
Bulimia nervosa (BN) is a common eating disorder that is characterized by periods of bingeing and purging. People with the dysregulated subtype of BN experience behavioral impulsivity; disruption of cognitive, affective, behavioral, and neurophysiological processes (dysregulation); interpersonal dysfunction; and poor treatment response. To date, no therapies have been tested for this specific population, and it is unknown whether therapy that directly focuses on treating BN symptoms or one that addresses both eating and personality disorder symptoms is more effective. Cognitive behavioral therapy (CBT), which concentrates on modifying patients' behaviors and ways of thinking, has been effective in treating BN. This study will compare the effectiveness of two types of CBT, focused and broad, in treating adult women with the dysregulated subtype of BN.
Participants in this single-blind study will be randomly assigned to receive 20 sessions of either broad (enhanced) or focused CBT. Participants will meet with a therapist once or twice weekly until 20 sessions have occurred. Broad CBT will address symptoms of BN, as well as those of the personality disorder. Focused CBT will concentrate only on BN symptoms. Before treatment begins, participants will complete a set of questionnaires pertaining to their experiences with BN, depression, anxiety, and interpersonal relationships. The questionnaires will be used throughout the study to assess participants' progress. Participants will also attend a clinical interview lasting approximately 3.5 hours. Questions will concern BN, other eating disorder symptoms, depression, anxiety, and interpersonal relationships. Blood samples and vital signs will also be taken at the time of the clinical interview and as needed later in the treatment process.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Center for Anxiety and Related Disorders, Boston University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Substance dependence
- Diagnosis of bipolar I disorder
- Psychosis
- Mental retardation
- Receiving psychosocial treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: CBT-EF
Participants will receive cognitive behavioral therapy - focused
|
Focused CBT concentrates only on BN symptoms.
There will be 20 sessions over the course of 5 months.
|
|
Experimental: CBT-EB
Participants will receive cognitive behavioral therapy - broad
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Eating disorder symptoms
Time Frame: Measured throughout the study
|
Measured throughout the study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Depression symptoms
Time Frame: Measured throughout the study
|
Measured throughout the study
|
|
Anxiety symptoms
Time Frame: Measured throughout the study
|
Measured throughout the study
|
|
Interpersonal relationships
Time Frame: Measured throughout the study
|
Measured throughout the study
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Heather Thompson-Brenner, PhD, Center for Anxiety and Related Disorders, Boston University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- K23MH071641 (U.S. NIH Grant/Contract)
- DATR AK-TNAI2 (Other Grant/Funding Number: Special grant NIMH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.