Clinical trial NCT00494858: Focused Versus Enhanced Cognitive Behavioral Therapy for Treating Women With Bulimia Nervosa
Official title: Treatment of Bulimia Nervosa: Dysregulated Subtype
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Eating Disorders
Keywords: Bulimia nervosa
Cognitive Behavioral Therapy
Personality Disorders
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2007-07-02
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Eating disorder symptoms
timeFrame: Measured throughout the study
Secondary outcomes:
measure: Depression symptoms
timeFrame: Measured throughout the study
measure: Anxiety symptoms
timeFrame: Measured throughout the study
measure: Interpersonal relationships
timeFrame: Measured throughout the study
Other outcomes:
Locations:
city: Boston
country: United States
facility: Center for Anxiety and Related Disorders, Boston University
state: Massachusetts
Study officials:
affiliation: Center for Anxiety and Related Disorders, Boston University
name: Heather Thompson-Brenner, PhD
role: PRINCIPAL_INVESTIGATOR
References: