Focused Versus Enhanced Cognitive Behavioral Therapy for Treating Women With Bulimia Nervosa

Study Overview
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Brief Summary
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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
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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.

Official Title
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Treatment of Bulimia Nervosa: Dysregulated Subtype

Conditions
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Eating Disorders

Intervention / Treatment
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* Behavioral: Cognitive behavioral therapy - focused (CBT-EF)
* Behavioral: Cognitive behavioral therapy - broad (EB)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CBT-EF<br>Participants will receive cognitive behavioral therapy - focused | Behavioral: Cognitive behavioral therapy - focused (CBT-EF)<br>* Focused CBT concentrates only on BN symptoms. There will be 20 sessions over the course of 5 months.<br>|
| Experimental: CBT-EB<br>Participants will receive cognitive behavioral therapy - broad | Behavioral: Cognitive behavioral therapy - broad (EB)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eating disorder symptoms |  | Measured throughout the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression symptoms |  | Measured throughout the study | 
| Anxiety symptoms |  | Measured throughout the study | 
| Interpersonal relationships |  | Measured throughout the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bulimia nervosa, Cognitive Behavioral Therapy, Personality Disorders