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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by National Institute of Mental Health (NIMH).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00494858
First received: June 28, 2007
Last updated: April 29, 2009
Last verified: April 2009
  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:


Further study details as provided by National Institute of Mental Health (NIMH):

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 ]

Estimated Enrollment: 74
Study Start Date: July 2007
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: May 2011 (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
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

Contacts
Contact: Heather Thompson-Brenner, PhD 617-353-9610 ht141@hotmail.com
Contact: Dana Satir, MA 617-353-9610 dana.satir@gmail.com

Locations
United States, Massachusetts
Center for Anxiety and Related Disorders, Boston University Recruiting
Boston, Massachusetts, United States, 02215
Contact: Heather Thompson-Brenner, PhD    617-353-9610    ht141@hotmail.com   
Contact: Dana Satir, MA    617-353-9610    dana.satir@gmail.com   
Principal Investigator: Heather Thompson-Brenner, PhD         
Sponsors and Collaborators
Investigators
Principal Investigator: Heather Thompson-Brenner, PhD Center for Anxiety and Related Disorders, Boston University
  More Information

No publications provided

Responsible Party: Heather Thompson-Brenner, Center for Anxiety and Related Disorders
ClinicalTrials.gov Identifier: NCT00494858     History of Changes
Other Study ID Numbers: K23 MH071641, DATR AK-TNAI2
Study First Received: June 28, 2007
Last Updated: April 29, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Bulimia nervosa
Cognitive Behavioral Therapy
Personality Disorders

Additional relevant MeSH terms:
Eating Disorders
Bulimia
Bulimia Nervosa
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014