Testing an Alternative Therapy for Bulimia Nervosa
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|ClinicalTrials.gov Identifier: NCT00773617|
Recruitment Status : Completed
First Posted : October 16, 2008
Last Update Posted : March 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Eating Disorders||Behavioral: ICAT Behavioral: CBT||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Integrative Cognitive Affective Therapy for Bulimia Nervosa (ICAT)|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||April 2011|
Integrative cognitive affective therapy (ICAT)
ICAT is a new manual-based psychotherapy treatment for bulimia nervosa (BN) that focuses on emotions and bulimic behavior.
Active Comparator: 2
Cognitive behavioral therapy (CBT)
CBT is a highly structured, manual-based psychotherapy that has been shown to be effective in the treatment of BN. CBT focuses on cognitions and bulimic behavior.
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- Study retention rates [ Time Frame: Measured weekly throughout treatment ]
- 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 ]
- 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 ]
- Self-discrepancy, as defined by the Selves Interview [ Time Frame: Measured at baseline, end of treatment, and at 32-week follow-up ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00773617
|United States, Minnesota|
|University of Minnesota Eating Disorders Research Program|
|Minneapolis, Minnesota, United States, 55454|
|United States, North Dakota|
|Neuropsychiatric Research Institute|
|Fargo, North Dakota, United States, 58103|
|Principal Investigator:||Stephen A. Wonderlich, PhD||Neuropsychiatric Research Institute, University of North Dakota|