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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Eating Disorders	Behavioral: Cognitive behavioral therapy - focused (CBT-EF); Behavioral: Cognitive behavioral therapy - broad (EB)	Phase 2

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 Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: CBT-EF; Participants will receive cognitive behavioral therapy - focused	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.
Experimental: CBT-EB; Participants will receive cognitive behavioral therapy - broad	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.

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Eating disorder symptoms [ Time Frame: Measured throughout the study ]

Secondary Outcome Measures :

1. Depression symptoms [ Time Frame: Measured throughout the study ]
2. Anxiety symptoms [ Time Frame: Measured throughout the study ]
3. Interpersonal relationships [ Time Frame: Measured throughout the study ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Massachusetts
Center for Anxiety and Related Disorders, Boston University
Boston, Massachusetts, United States, 02215

Sponsors and Collaborators

Boston University

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:	Heather Thompson-Brenner, PhD	Center for Anxiety and Related Disorders, Boston University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Boston University
ClinicalTrials.gov Identifier:	NCT00494858 History of Changes
Other Study ID Numbers:	K23MH071641 ( U.S. NIH Grant/Contract ); DATR AK-TNAI2
First Posted:	July 2, 2007
Last Update Posted:	July 20, 2016
Last Verified:	July 2016

Keywords provided by Boston University:

Bulimia nervosa; Cognitive Behavioral Therapy; Personality Disorders

Additional relevant MeSH terms:

Feeding and Eating Disorders; Bulimia; Bulimia Nervosa; Mental Disorders	Hyperphagia; Signs and Symptoms, Digestive; Signs and Symptoms