Focused Versus Enhanced Cognitive Behavioral Therapy for Treating Women With Bulimia Nervosa - Full Text View

Purpose

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	Intervention	Phase
Eating Disorders	Behavioral: Cognitive behavioral therapy - focused (CBT-EF) Behavioral: Cognitive behavioral therapy - broad (EB)	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Treatment of Bulimia Nervosa: Dysregulated Subtype

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Eating Disorders

U.S. FDA Resources

Further study details as provided by Boston University:

Primary Outcome Measures:

Eating disorder symptoms [ Time Frame: Measured throughout the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Depression symptoms [ Time Frame: Measured throughout the study ] [ Designated as safety issue: No ]
Anxiety symptoms [ Time Frame: Measured throughout the study ] [ Designated as safety issue: No ]
Interpersonal relationships [ Time Frame: Measured throughout the study ] [ Designated as safety issue: No ]


Enrollment:	50
Study Start Date:	July 2007
Study Completion Date:	December 2012
Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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.

Eligibility


Ages Eligible for Study:	18 Years to 65 Years (Adult)
Genders 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00494858

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


Responsible Party:	Boston University
ClinicalTrials.gov Identifier:	NCT00494858 History of Changes
Other Study ID Numbers:	K23MH071641 DATR AK-TNAI2
Study First Received:	June 28, 2007
Last Updated:	July 18, 2016
Health Authority:	United States: Federal Government

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

ClinicalTrials.gov processed this record on September 23, 2016