A Relapse Prevention Program for Reducing Relapse and Fear of Food in People With Anorexia Nervosa
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|ClinicalTrials.gov Identifier: NCT00627341|
Recruitment Status : Completed
First Posted : March 3, 2008
Last Update Posted : May 11, 2012
|Condition or disease||Intervention/treatment||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 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Addressing Fear of Food in Anorexia Nervosa|
|Study Start Date :||December 2007|
|Primary Completion Date :||December 2010|
|Study Completion Date :||December 2010|
Experimental: Exposure and Response Prevention
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.
Active Comparator: Cognitive Behavior Therapy
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.
- Diet Energy Density and Variety score [ Time Frame: Measured before treatment and at Months 1, 2, 3, 4, 5, and 6 ]
- Yale-Brown-Cornell Obsessive-Compulsive Scale for Eating Disorders (YBC-EDS) score [ Time Frame: Measured before treatment and at Months 3 and 6 ]
- Body mass index (BMI) [ Time Frame: Measured weekly for 6 months ]
- Amount consumed at test meals [ Time Frame: Measured two times before treatment and two times after Month 6 ]
- Reported levels of anxiety at test meals [ Time Frame: Measured two times before treatment and two times after Month 6 ]
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): NCT00627341
|United States, New York|
|New York State Psychiatric Institute|
|New York, New York, United States, 10032|
|Principal Investigator:||Joanna E. Steinglass, MD||Research Foundation for Mental Hygiene, Inc.|