Focused Versus Enhanced Cognitive Behavioral Therapy for Treating Women With Bulimia Nervosa
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| ClinicalTrials.gov Identifier: NCT00494858 |
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Recruitment Status :
Completed
First Posted : July 2, 2007
Last Update Posted : July 20, 2016
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Eating Disorders | Behavioral: Cognitive behavioral therapy - focused (CBT-EF) Behavioral: Cognitive behavioral therapy - broad (EB) | Phase 2 |
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 : | Interventional (Clinical Trial) |
| Actual Enrollment : | 50 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Treatment of Bulimia Nervosa: Dysregulated Subtype |
| Study Start Date : | July 2007 |
| Actual Primary Completion Date : | December 2012 |
| Actual Study Completion Date : | December 2012 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: CBT-EF
Participants will receive cognitive behavioral therapy - focused
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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. |
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Experimental: CBT-EB
Participants will receive cognitive behavioral therapy - broad
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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. |
- Eating disorder symptoms [ Time Frame: Measured throughout the study ]
- Depression symptoms [ Time Frame: Measured throughout the study ]
- Anxiety symptoms [ Time Frame: Measured throughout the study ]
- Interpersonal relationships [ Time Frame: Measured throughout the study ]
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00494858
| United States, Massachusetts | |
| Center for Anxiety and Related Disorders, Boston University | |
| Boston, Massachusetts, United States, 02215 | |
| Principal Investigator: | Heather Thompson-Brenner, PhD | Center for Anxiety and Related Disorders, Boston University |
| Responsible Party: | Boston University |
| ClinicalTrials.gov Identifier: | NCT00494858 History of Changes |
| Other Study ID Numbers: |
K23MH071641 ( U.S. NIH Grant/Contract ) K23MH071641 ( U.S. NIH Grant/Contract ) DATR AK-TNAI2 |
| First Posted: | July 2, 2007 Key Record Dates |
| Last Update Posted: | July 20, 2016 |
| Last Verified: | July 2016 |
Keywords provided by Boston University:
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Bulimia nervosa Cognitive Behavioral Therapy Personality Disorders |
Additional relevant MeSH terms:
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Feeding and Eating Disorders Bulimia Bulimia Nervosa Mental Disorders |
Hyperphagia Signs and Symptoms, Digestive Signs and Symptoms |