|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00773617 |
Purpose
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).
| Condition | Intervention |
|---|---|
|
Eating Disorders |
Behavioral: ICAT Behavioral: CBT |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Integrative Cognitive Affective Therapy for Bulimia Nervosa (ICAT) |
| Estimated Enrollment: | 80 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | April 2011 |
| Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Integrative cognitive affective therapy (ICAT)
|
Behavioral: ICAT
ICAT is a new manual-based psychotherapy treatment for bulimia nervosa (BN) that focuses on emotions and bulimic behavior.
Other Name: ICAT
|
|
Active Comparator: 2
Cognitive behavioral therapy (CBT)
|
Behavioral: 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.
Other Name: 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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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, Minnesota | |
| University of Minnesota Eating Disorders Research Program | Recruiting |
| Minneapolis, Minnesota, United States, 55454 | |
| Contact: Carol B. Peterson, PhD 612-627-4493 peter161@umn.edu | |
| Contact: Scott J. Crow, MD 612-273-9807 crowx002@umn.edu | |
| Principal Investigator: Carol B. Peterson, PhD | |
| Sub-Investigator: Scott J. Crow, MD | |
| United States, North Dakota | |
| Neuropsychiatric Research Institute | Recruiting |
| Fargo, North Dakota, United States, 58103 | |
| Contact: Stephen A. Wonderlich, PhD 701-293-1335 stephenw@medicine.nodak.edu | |
| Contact: James E. Mitchell, MD 701-293-1335 jmitchell@nrifargo.com | |
| Principal Investigator: Stephen A. Wonderlich, PhD | |
| Principal Investigator: James E. Mitchell, MD | |
| Principal Investigator: | Stephen A. Wonderlich, PhD | Neuropsychiatric Research Institute, University of North Dakota |
More Information
| Responsible Party: | Stephen A. Wonderlich, PhD, Neuropsychiatric Research Institute |
| ClinicalTrials.gov Identifier: | NCT00773617 History of Changes |
| Other Study ID Numbers: | R34 MH077571, 5 R34 MH077571-02, DATR A2-AIM |
| Study First Received: | October 15, 2008 |
| Last Updated: | March 23, 2009 |
| Health Authority: | United States: Federal Government |
|
Bulimia Nervosa Treatment Efficacy Integrative Cognitive Affective Therapy Cognitive Behavior Therapy |
|
Bulimia Bulimia Nervosa Eating Disorders Hyperphagia |
Signs and Symptoms, Digestive Signs and Symptoms Mental Disorders |