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Testing an Alternative Therapy for Bulimia Nervosa
This study is currently recruiting participants.
Study NCT00773617   Information provided by National Institute of Mental Health (NIMH)
First Received: October 15, 2008   Last Updated: March 23, 2009   History of Changes

October 15, 2008
March 23, 2009
March 2009
April 2011   (final data collection date for primary outcome measure)
  • Percent reduction in binging or purging frequency as defined by symptom recall (SR) [ Time Frame: Measured at baseline, weekly intervals throughout the duration of therapy, end of treatment, and 32-week follow-up ] [ Designated as safety issue: No ]
  • Percent reduction in binging or purging frequency, as defined by the Eating Disorders Examination (EDE) [ Time Frame: Measured at baseline, end of treatment, and 32-week follow-up ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00773617 on ClinicalTrials.gov Archive Site
  • Reduction in depression, as defined by the Beck Depression Inventory (BDI) [ Time Frame: Measured at baseline, therapy session eight, end of treatment, and 32-week follow-up ] [ Designated as safety issue: No ]
  • Reduction in anxiety as defined by the State-Trait Anxiety Inventory (STAI) [ Time Frame: Measured at baseline, therapy session eight, end of treatment, and 32-week follow-up ] [ Designated as safety issue: No ]
  • Abstinence from binging and purging behavior, as defined by SR and EDE [ Time Frame: Measured at the end of treatment and 32-week follow-up ] [ Designated as safety issue: No ]
  • Study retention rates [ Time Frame: Measured weekly throughout treatment ] [ Designated as safety issue: No ]
  • Patient and therapist satisfaction, as defined by the Treatment Acceptability, Feasibility and Satisfaction Scale (TAFSQ) [ Time Frame: Measured at therapy session two, therapy session eight, end of treatment, and 32-week follow-up ] [ Designated as safety issue: No ]
  • Self-esteem, as defined by the Rosenberg Self Esteem Questionnaire (RSEQ) [ Time Frame: Measured at baseline, therapy session eight, end of treatment, and 32-week follow-up ] [ Designated as safety issue: No ]
  • Self-discrepancy, as defined by the Selves Interview [ Time Frame: Measured at baseline, end of treatment, and at 32-week follow-up ] [ Designated as safety issue: No ]
Same as current
 
Testing an Alternative Therapy for Bulimia Nervosa
Integrative Cognitive Affective Therapy for Bulimia Nervosa (ICAT)

This study will compare a new method of treatment for bulimia nervosa (ICAT), integrative cognitive-affective therapy, to the current standard method of treatment, cognitive behavioral therapy (CBT).

Bulimia nervosa (BN) is a disorder characterized by binge eating and compensatory behaviors, such as self-induced vomiting or laxative abuse. It affects 1% to 2% of adolescents and young women, and occurs more rarely in men. People who suffer from BN are also more likely to suffer from other psychiatric disorders, such as anxiety disorders, mood disorders, substance abuse disorders, and personality disorders—those categorized as Axis II in the DSM IV.

Integrative cognitive-affective therapy (ICAT) is a new treatment developed as an alternative to cognitive behavioral therapy (CBT) for treating people with BN. CBT is the standard treatment for BN. ICAT uses some elements from CBT and some elements from therapies used to treat other disorders. Some elements of ICAT are also used to treat substance abuse disorders, depression, and personality disorders. This study will compare the effectiveness of ICAT and CBT in treating BN.

Participants in this study, who must have BN symptoms, will be randomly assigned to receive either CBT or ICAT treatment. Participation in this study will last 18 weeks for participants assigned to receive CBT and 16 weeks for participants assigned to receive ICAT. Both treatments will consist of 20 individual therapy sessions lasting 50 minutes. Additionally, participants receiving ICAT will receive personal digital assistant (PDA) devices installed with therapeutic modules. Use of these modules will be unlimited during the period of ICAT treatment and will be recorded at study visits. Over the course of 2 screening visits, participants will complete questionnaires, undergo clinical interviews, and go through a medical screening that involves a blood test of electrolytes and a urine test for pregnancy. Each screening visit will take 2 to 3 hours. At the end of treatment and 4 months after treatment completion, participants will undergo 2 assessments, both of which will include 2 hours of interviews and questionnaires. During these assessments researchers will evaluate weight; eating behavior; and associated problems with mood, anxiety, obsessive-compulsive symptoms, self-concept, social adjustment, and other areas of psychosocial functioning.

 
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Eating Disorders
  • Behavioral: ICAT
  • Behavioral: CBT
  • Experimental: Integrative cognitive affective therapy (ICAT)
  • Active Comparator: Cognitive behavioral therapy (CBT)
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
80
April 2011
April 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Bulimia nervosa, as defined by DSM-IV, or bulimic symptoms, as defined as purging episodes (with objective or subjective binge eating) that occur at least once per week for the past 3 months

Exclusion Criteria:

  • Past or current diagnosis of psychosis or bipolar disorder
  • Inability to read English
  • Medical instability, including electrolyte abnormalities
  • Psychotherapy or pharmacotherapy initiated within 6 weeks of study entry
  • Pregnant or lactating
  • Drug or alcohol dependence in the past 6 months or drug or alcohol abuse in the past 6 weeks
  • Severe cognitive impairment or mental retardation
Both
18 Years to 65 Years
No
Contact: Stephen A. Wonderlich, PhD 701-293-1335 stephenw@medicine.nodak.edu
Contact: Carol B. Peterson, PhD 612-627-4496 peter161@umn.edu
United States
 
NCT00773617
Stephen A. Wonderlich, PhD, Neuropsychiatric Research Institute
R34 MH077571, 5 R34 MH077571-02, DATR A2-AIM
National Institute of Mental Health (NIMH)
 
Principal Investigator: Stephen A. Wonderlich, PhD Neuropsychiatric Research Institute, University of North Dakota
National Institute of Mental Health (NIMH)
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP