Focused Versus Enhanced Cognitive Behavioral Therapy for Treating Women With Bulimia Nervosa
Primary Purpose
Eating Disorders
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cognitive behavioral therapy - focused (CBT-EF)
Cognitive behavioral therapy - broad (EB)
Sponsored by
About this trial
This is an interventional treatment trial for Eating Disorders focused on measuring Bulimia nervosa, Cognitive Behavioral Therapy, Personality Disorders
Eligibility Criteria
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
Sites / Locations
- Center for Anxiety and Related Disorders, Boston University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
CBT-EF
CBT-EB
Arm Description
Participants will receive cognitive behavioral therapy - focused
Participants will receive cognitive behavioral therapy - broad
Outcomes
Primary Outcome Measures
Eating disorder symptoms
Secondary Outcome Measures
Depression symptoms
Anxiety symptoms
Interpersonal relationships
Full Information
NCT ID
NCT00494858
First Posted
June 28, 2007
Last Updated
July 18, 2016
Sponsor
Boston University
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00494858
Brief Title
Focused Versus Enhanced Cognitive Behavioral Therapy for Treating Women With Bulimia Nervosa
Official Title
Treatment of Bulimia Nervosa: Dysregulated Subtype
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston University
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorders
Keywords
Bulimia nervosa, Cognitive Behavioral Therapy, Personality Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CBT-EF
Arm Type
Active Comparator
Arm Description
Participants will receive cognitive behavioral therapy - focused
Arm Title
CBT-EB
Arm Type
Experimental
Arm Description
Participants will receive cognitive behavioral therapy - broad
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy - focused (CBT-EF)
Intervention Description
Focused CBT concentrates only on BN symptoms. There will be 20 sessions over the course of 5 months.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy - broad (EB)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Eating disorder symptoms
Time Frame
Measured throughout the study
Secondary Outcome Measure Information:
Title
Depression symptoms
Time Frame
Measured throughout the study
Title
Anxiety symptoms
Time Frame
Measured throughout the study
Title
Interpersonal relationships
Time Frame
Measured throughout the study
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather Thompson-Brenner, PhD
Organizational Affiliation
Center for Anxiety and Related Disorders, Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Anxiety and Related Disorders, Boston University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Focused Versus Enhanced Cognitive Behavioral Therapy for Treating Women With Bulimia Nervosa
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