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| Sponsored by: |
National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00627341 |
Purpose
This study will compare the effectiveness of two types of psychotherapy, a relapse prevention program and cognitive behavioral therapy, in reducing relapse and fear of eating situations in people with anorexia nervosa.
| Condition | Intervention | Phase |
|---|---|---|
|
Eating Disorders |
Behavioral: Food Exposure Therapy and Ritual Prevention with Motivational Enhancement for Relapse Prevention in Anorexia Nervosa (AN-EX/RP) Behavioral: Cognitive behavioral therapy (CBT) |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study |
| Official Title: | Addressing Fear of Food in Anorexia Nervosa |
| Estimated Enrollment: | 40 |
| Study Start Date: | December 2007 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Participants will receive Food Exposure Therapy and Ritual Prevention with Motivational Enhancement for Relapse Prevention in Anorexia Nervosa for 6 months.
|
Behavioral: Food Exposure Therapy and Ritual Prevention with Motivational Enhancement for Relapse Prevention in Anorexia Nervosa (AN-EX/RP)
AN-EX/RP will consist of in-session exposures to feared eating situations without using avoidance behaviors as well as formal motivational interviewing techniques.
|
|
2: Active Comparator
Participants will receive cognitive behavioral therapy for anorexia nervosa for 6 months.
|
Behavioral: Cognitive behavioral therapy (CBT)
CBT for anorexia nervosa sessions will focus on behaviorally normalizing eating patterns throughout the day and on cognitively addressing dysfunctional thinking that promotes disordered eating.
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Anorexia nervosa (AN) is a serious and often chronic eating disorder characterized by restrictive eating habits and failure to maintain a healthy minimal body weight. Symptoms of AN may include distorted body image, fear of weight gain, obsessive exercise, and binge and purge eating behaviors. In severe cases of AN, a person may practice extreme dieting to levels of near starvation. These unhealthy behaviors may cause further medical complications, including organ damage, irregular heart rhythm, premature osteoporosis, and heart failure. AN has one of the highest mortality rates of all psychiatric disorders, claiming the lives of up to 6% of those affected. When treated with a form of psychotherapy and nutritional guidance, people can restore weight to healthy levels and recover from AN, but the chance of relapse remains high. A program aimed specifically at reducing relapse, Exposure Therapy and Ritual Prevention with Motivational Enhancement for Relapse Prevention in Anorexia Nervosa (AN-EX/RP), may be more effective than common psychotherapy treatments, such as cognitive behavioral therapy (CBT), in enhancing long-term recovery from AN. This study will compare the effectiveness of AN-EX/RP with CBT in reducing relapse and fear of eating situations in people with AN.
Participants in this study will include patients who have achieved normal weight while inpatients at the New York State Psychiatric Unit. Eligible participants will undergo initial assessments that will include questionnaires, interviews, and two laboratory-based meals. Participants will then be assigned randomly to receive 6 months of outpatient psychotherapy treatment with either AN-EX/RP or CBT. Participants assigned to receive AN-EX/RP will attend 90-minute sessions twice weekly for the first few months, then weekly thereafter. Sessions will focus on fear of eating situations and will help participants to confront, rather than avoid, these fears in order to learn through practice that the fears are unrealistic. Participants assigned to receive CBT will attend treatment sessions twice weekly for the first month and then weekly thereafter. CBT sessions will focus on thoughts, feelings, and behaviors that perpetuate the eating disorder, with the aim to develop healthier patterns. After completing the 6 months of treatment, all participants will repeat the initial assessments.
Eligibility| Ages Eligible for Study: | 16 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Laura A. Berner, BA | 212-543-5316 |
| United States, New York | |
| New York State Psychiatric Institute | Recruiting |
| New York, New York, United States, 10032 | |
| Principal Investigator: Joanna E. Steinglass, MD | |
| Sub-Investigator: B. T. Walsh, MD | |
| Principal Investigator: | Joanna E. Steinglass, MD | Research Foundation for Mental Hygiene, Inc. |
More Information
| Responsible Party: | Research Foundation for Mental Hygiene, Inc. ( Joanna Steinglass, MD ) |
| Study ID Numbers: | R01 MH082736, DATR A2-AID |
| Study First Received: | February 28, 2008 |
| Last Updated: | April 8, 2009 |
| ClinicalTrials.gov Identifier: | NCT00627341 History of Changes |
| Health Authority: | United States: Federal Government |
|
Exposure Therapy Relapse Prevention Anorexia Nervosa |
|
Signs and Symptoms Signs and Symptoms, Digestive Mental Disorders |
Anorexia Anorexia Nervosa Eating Disorders |
|
Signs and Symptoms Signs and Symptoms, Digestive Mental Disorders |
Anorexia Anorexia Nervosa Eating Disorders |