Focused Versus Enhanced Cognitive Behavioral Therapy for Treating Women With Bulimia Nervosa
Recruitment status was Recruiting
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Purpose
This study will compare the effectiveness of two types of cognitive behavioral therapy in treating adult women with the dysregulated subtype of bulimia nervosa.
| Condition | Intervention | Phase |
|---|---|---|
|
Eating Disorders |
Behavioral: Cognitive behavioral therapy - focused (CBT-EF) Behavioral: Cognitive behavioral therapy - broad (EB) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Treatment of Bulimia Nervosa: Dysregulated Subtype |
- Eating disorder symptoms [ Time Frame: Measured throughout the study ] [ Designated as safety issue: No ]
- Depression symptoms [ Time Frame: Measured throughout the study ] [ Designated as safety issue: No ]
- Anxiety symptoms [ Time Frame: Measured throughout the study ] [ Designated as safety issue: No ]
- Interpersonal relationships [ Time Frame: Measured throughout the study ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 74 |
| Study Start Date: | July 2007 |
| Estimated Study Completion Date: | May 2011 |
| Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: CBT-EF
Participants will receive cognitive behavioral therapy - focused
|
Behavioral: Cognitive behavioral therapy - focused (CBT-EF)
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
|
Behavioral: Cognitive behavioral therapy - broad (EB)
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Heather Thompson-Brenner, PhD | 617-353-9610 | ht141@hotmail.com |
| Contact: Dana Satir, MA | 617-353-9610 | dana.satir@gmail.com |
| United States, Massachusetts | |
| Center for Anxiety and Related Disorders, Boston University | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Heather Thompson-Brenner, PhD 617-353-9610 ht141@hotmail.com | |
| Contact: Dana Satir, MA 617-353-9610 dana.satir@gmail.com | |
| Principal Investigator: Heather Thompson-Brenner, PhD | |
| Principal Investigator: | Heather Thompson-Brenner, PhD | Center for Anxiety and Related Disorders, Boston University |
More Information
No publications provided
| Responsible Party: | Heather Thompson-Brenner, Center for Anxiety and Related Disorders |
| ClinicalTrials.gov Identifier: | NCT00494858 History of Changes |
| Other Study ID Numbers: | K23 MH071641, DATR AK-TNAI2 |
| Study First Received: | June 28, 2007 |
| Last Updated: | April 29, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Mental Health (NIMH):
|
Bulimia nervosa Cognitive Behavioral Therapy Personality Disorders |
Additional relevant MeSH terms:
|
Bulimia Eating Disorders Bulimia Nervosa Hyperphagia |
Signs and Symptoms, Digestive Signs and Symptoms Mental Disorders |
ClinicalTrials.gov processed this record on June 18, 2013