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| Descriptive Information Fields | |||||
| Brief Title † | A Relapse Prevention Program for Reducing Relapse and Fear of Food in People With Anorexia Nervosa | ||||
| Official Title † | Addressing Fear of Food in Anorexia Nervosa | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase I, Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | Diet Energy Density score [ Time Frame: Measured before treatment and at Months 1, 2, 3, 4, 5, and 6 ] [ Designated as safety issue: No ] Diet Variety score [ Time Frame: Measured before treatment and at Months 1, 2, 3, 4, 5, and 6 ] [ Designated as safety issue: No ] |
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| Secondary Outcome Measure † | Yale-Brown-Cornell Obsessive-Compulsive Scale for Eating Disorders (YBC-EDS) score [ Time Frame: Measured before treatment and at Months 3 and 6 ] [ Designated as safety issue: No ] Body mass index (BMI) [ Time Frame: Measured weekly for 6 months ] [ Designated as safety issue: No ] Amount consumed at test meals [ Time Frame: Measured two times before treatment and two times after Month 6 ] [ Designated as safety issue: No ] Reported levels of anxiety at test meals [ Time Frame: Measured two times before treatment and two times after Month 6 ] [ Designated as safety issue: No ] |
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| Condition † | Eating Disorders | ||||
| Intervention † | Behavioral: Food Exposure Therapy and Ritual Prevention with Motivational Enhancement for Relapse Prevention in Anorexia Nervosa (AN-EX/RP) Behavioral: Cognitive behavioral therapy (CBT) |
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| MEDLINE PMIDs | |||||
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| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 40 | ||||
| Start Date † | December 2007 | ||||
| Completion Date | |||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 16 Years to 45 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
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| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00627341 | ||||
| Organization ID | R01 MH082736 | ||||
| Secondary IDs †† | DATR A2-AID | ||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||
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| Investigators † |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||
| Verification Date | August 2008 | ||||
| First Received Date † | February 28, 2008 | ||||
| Last Updated Date | August 25, 2008 | ||||