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

Phase 2

Completed

• Conditions: Eating Disorders
• Interventions: Behavioral: Cognitive behavioral therapy - focused (CBT-EF); Behavioral: Cognitive behavioral therapy - broad (EB)

• Registration Number: NCT00494858
• Lead Sponsor: Boston University

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.

Study Timeline

• Study First Submitted: 2007-06-28
• Study First Submitted QC: 2007-06-28
• Study Start: 2007-07
• Study First Posted: 2007-07-02
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-18
• Last Update Posted: 2016-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBT-EF	Cognitive behavioral therapy - focused (CBT-EF)	Participants will receive cognitive behavioral therapy - focused
CBT-EB	Cognitive behavioral therapy - broad (EB)	Participants will receive cognitive behavioral therapy - broad

Primary Outcome Measures

Name	Time	Method
Eating disorder symptoms	Measured throughout the study

Secondary Outcome Measures

Name	Time	Method
Anxiety symptoms	Measured throughout the study
Interpersonal relationships	Measured throughout the study
Depression symptoms	Measured throughout the study

Trial Locations

Locations (1)

Center for Anxiety and Related Disorders, Boston University; 🇺🇸 Boston, Massachusetts, United States