A Phase 1/2 interventional study of Food Exposure Therapy and Ritual Prevention with Motivational Enhancement for Relapse Prevention in Anorexia Nervosa (AN-EX/RP) and Cognitive behavioral therapy (CBT) in Eating Disorders, sponsored by New York State Psychiatric Institute. Completed at 1 site in United States. Open to participants aged 16 Years to 45 Years. Per ClinicalTrials.gov, last updated 2012-05-11.
Sponsored by New York State Psychiatric Institute · Phase 1/2, Interventional, and Prevention
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.
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.
411 studies on the registry are indexed under Anorexia; 67 are open to participants now.
This study's enrollment of 34 is below the median of 41 across 287 interventional studies indexed under Anorexia.
Browse Anorexia studies →New York State Psychiatric Institute is the lead sponsor of 425 studies on the registry; 26 are open to participants now.
Of its 50 completed or terminated interventional studies of FDA-regulated products, 45 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
Participants will receive cognitive behavioral therapy for anorexia nervosa for 6 months.
Behavioral: Cognitive behavioral therapy (CBT)
AN-EX/RP will consist of in-session exposures to feared eating situations without using avoidance behaviors as well as formal motivational interviewing techniques.
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
This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
New York State Psychiatric Institute