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

Eating Disorders Clinical Trial

Official title:

Treatment of Bulimia Nervosa: Dysregulated Subtype

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00494858
• Other study ID #: K23MH071641
• Secondary ID: K23MH071641DATR
• Status: Completed
• Phase: Phase 2
• First received: June 28, 2007
• Last updated: July 18, 2016
• Start date: July 2007
• Est. completion date: December 2012

Study information

• Verified date: July 2016
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bulimia
• Bulimia Nervosa
• Eating Disorders
• Feeding and Eating Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Center for Anxiety and Related Disorders, Boston University	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eating disorder symptoms		Measured throughout the study	No
Secondary	Depression symptoms		Measured throughout the study	No
Secondary	Anxiety symptoms		Measured throughout the study	No
Secondary	Interpersonal relationships		Measured throughout the study	No