A Relapse Prevention Program for Reducing Relapse and Fear of Food in People With Anorexia Nervosa

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Addressing Fear of Food in Anorexia Nervosa

Conditions
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Eating Disorders

Intervention / Treatment
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* Behavioral: Food Exposure Therapy and Ritual Prevention with Motivational Enhancement for Relapse Prevention in Anorexia Nervosa (AN-EX/RP)
* Behavioral: Cognitive behavioral therapy (CBT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meets DSM-IV-TR criteria for anorexia nervosa (restricting or binge-purge subtype), with or without amenorrhea after inpatient admission Has achieved 90% of ideal body weight or BMI greater than or equal to 19.5 kg/m2 for at least 1 week after inpatient admission Medically stable Exclusion Criteria: Chronic psychotic or bipolar I disorder requiring ongoing treatment with antipsychotic or mood stabilizer Diagnosis of obsessive compulsive disorder in which the symptoms are clearly unrelated to eating disorders Current substance abuse Current use of psychotropic medication Acute suicidality (suicidality or self-injury in the 3 months before study entry) Serious medical illness

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exposure and Response Prevention<br>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)<br>* AN-EX/RP will consist of in-session exposures to feared eating situations without using avoidance behaviors as well as formal motivational interviewing techniques.<br>|
| Active Comparator: Cognitive Behavior Therapy<br>Participants will receive cognitive behavioral therapy for anorexia nervosa for 6 months. | Behavioral: Cognitive behavioral therapy (CBT)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diet Energy Density and Variety score |  | Measured before treatment and at Months 1, 2, 3, 4, 5, and 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Yale-Brown-Cornell Obsessive-Compulsive Scale for Eating Disorders (YBC-EDS) score |  | Measured before treatment and at Months 3 and 6 | 
| Body mass index (BMI) |  | Measured weekly for 6 months | 
| Amount consumed at test meals |  | Measured two times before treatment and two times after Month 6 | 
| Reported levels of anxiety at test meals |  | Measured two times before treatment and two times after Month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exposure Therapy, Relapse Prevention, Anorexia Nervosa