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

Boston University

Status and phase: Completed; Phase 2

Conditions: Eating Disorders

Treatments: Behavioral: Cognitive behavioral therapy - focused (CBT-EF); Behavioral: Cognitive behavioral therapy - broad (EB)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00494858

K23MH071641 (U.S. NIH Grant/Contract)

DATR AK-TNAI2

Details and patient eligibility

About

This study will compare the effectiveness of two types of cognitive behavioral therapy in treating adult women with the dysregulated subtype of bulimia nervosa.

Full 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.

Enrollment: 50 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

CBT-EF

Active Comparator group

Description:

Participants will receive cognitive behavioral therapy - focused

Treatment:

Behavioral: Cognitive behavioral therapy - focused (CBT-EF)

CBT-EB

Experimental group

Description:

Participants will receive cognitive behavioral therapy - broad

Treatment:

Behavioral: Cognitive behavioral therapy - broad (EB)