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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00601822 |
This study will evaluate the effectiveness of adding cognitive remediation therapy to cognitive behavioral therapy for treating people with anorexia nervosa.
Condition | Intervention | Phase |
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Anorexia Nervosa |
Behavioral: Cognitive remediation therapy (CRT) Behavioral: Cognitive behavioral therapy (CBT) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study |
Official Title: | Cognitive Remediation Therapy for Anorexia Nervosa |
Estimated Enrollment: | 46 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Group receiving cognitive behavioral therapy for anorexia nervosa (CBT-AN)
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Behavioral: Cognitive behavioral therapy (CBT)
CBT includes 20 to 28 weekly psychotherapy sessions over 6 months, depending on treatment group assignment. CBT sessions aim to change participants' beliefs and behaviors toward eating disorders and to teach ways to handle the daily struggles of an eating disorder.
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2: Experimental
Group receiving cognitive behavioral therapy for anorexia nervosa, plus cognitive remediation therapy (CBT-AN+CRT)
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Behavioral: Cognitive remediation therapy (CRT)
CRT includes eight sessions over 6 months that aim to improve cognitive flexibility and strengthen thinking skills.
Behavioral: Cognitive behavioral therapy (CBT)
CBT includes 20 to 28 weekly psychotherapy sessions over 6 months, depending on treatment group assignment. CBT sessions aim to change participants' beliefs and behaviors toward eating disorders and to teach ways to handle the daily struggles of an eating disorder.
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Anorexia nervosa (AN) is a serious and often chronic eating disorder characterized by low body weight and an obsessive fear of weight gain. People with AN usually try to control body weight by purging, excessive exercise, and/or restrictive eating to near starvation. These dangerous habits and the resultant weight loss in people with AN can lead to serious health complications, including anemia, osteoporosis, and kidney and heart problems. While there is no one known cause for AN, it is believed that a number of psychological, sociological, and neurobiological factors may contribute. Currently, there are no psychological or medication-based treatments known to be highly effective in treating adults with AN. This lack of treatment success may be due to the low retention rates present in AN treatment programs. Cognitive remediation therapy (CRT), a type of psychotherapy that concentrates on improving memory and cognitive flexibility, may be helpful in improving AN treatment adherence. This study will evaluate the effectiveness of adding CRT to cognitive behavioral therapy (CBT) for improving treatment retention rates and for treating people with AN.
Participation in this study will last 1 year and will consist of 6 months of treatment and one follow-up session at 6 months post-treatment. All participants will first undergo baseline assessments, which include interviews and questionnaires about psychological history and AN symptoms, an Eating Disorder Examination (EDE) interview, and a variety of cognitive tests. The questionnaires and cognitive tests will be repeated various times throughout treatment. After baseline assessments, participants will be randomly assigned to receive CBT specifically tailored for AN with or without CRT. Participants assigned to the CBT-only group will receive 28 weekly sessions of CBT with a therapist. Participants assigned to the CBT plus CRT group will receive 8 sessions of CRT and 20 sessions of CBT with a therapist. At each therapy session, participants will have their vital signs checked. In addition, participants will have blood drawn to measure electrolyte levels at baseline and every month during treatment. An electrocardiogram (EKG) will also be taken at baseline and Months 3 and 6. All baseline assessments will be repeated 6 months after the completion of treatment.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Judy G. Beenhakker, MS | 650-723-7885 | judybeen@stanford.edu |
Contact: Sarah E. Forsberg, BA | 650-723-9182 | sarah523@stanford.edu |
United States, California | |
Stanford University | Recruiting |
Stanford, California, United States, 94305 | |
Principal Investigator: James D. Lock, MD, PhD |
Principal Investigator: | James D. Lock, MD, PhD | Stanford University |
Responsible Party: | Stanford University Child and Adolescent Psychiatry ( James D. Lock, MD, PhD ) |
Study ID Numbers: | R01 MH082706, 98328, DATR A2-AID |
Study First Received: | January 4, 2008 |
Last Updated: | August 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00601822 |
Health Authority: | United States: Federal Government |
Signs and Symptoms Signs and Symptoms, Digestive Mental Disorders Anorexia |
Anorexia Nervosa Urinary Retention Eating Disorders |