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

NCT ID: NCT00494858

Last Updated: 2016-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2012-12-31

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.

Conditions

Eating Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CBT-EF

Participants will receive cognitive behavioral therapy - focused

Group Type: ACTIVE_COMPARATOR

Cognitive behavioral therapy - focused (CBT-EF)

Intervention Type: BEHAVIORAL

Focused CBT concentrates only on BN symptoms. There will be 20 sessions over the course of 5 months.

CBT-EB

Participants will receive cognitive behavioral therapy - broad

Group Type: EXPERIMENTAL

Cognitive behavioral therapy - broad (EB)

Intervention Type: BEHAVIORAL

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.

Interventions

Cognitive behavioral therapy - focused (CBT-EF)

Focused CBT concentrates only on BN symptoms. There will be 20 sessions over the course of 5 months.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Boston University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heather Thompson-Brenner, PhD

Role: PRINCIPAL_INVESTIGATOR

Center for Anxiety and Related Disorders, Boston University

Locations

Center for Anxiety and Related Disorders, Boston University

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

K23MH071641

Identifier Type: NIH

Identifier Source: secondary_id

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DATR AK-TNAI2

Identifier Type: -

Identifier Source: secondary_id

K23MH071641

Identifier Type: NIH

Identifier Source: org_study_id

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