Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01MH082736 | U.S. NIH Grant/Contract | View source | |
| DATR A2-AID |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exposure and Response Prevention | Experimental | Participants will receive Food Exposure Therapy and Ritual Prevention with Motivational Enhancement for Relapse Prevention in Anorexia Nervosa for 6 months. |
|
| Cognitive Behavior Therapy | Active Comparator | Participants will receive cognitive behavioral therapy for anorexia nervosa for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Food Exposure Therapy and Ritual Prevention with Motivational Enhancement for Relapse Prevention in Anorexia Nervosa (AN-EX/RP) | Behavioral | AN-EX/RP will consist of in-session exposures to feared eating situations without using avoidance behaviors as well as formal motivational interviewing techniques. |
| Measure | Description | Time Frame |
|---|---|---|
| Diet Energy Density and Variety score | Measured before treatment and at Months 1, 2, 3, 4, 5, and 6 |
| 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 | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Joanna E. Steinglass, MD | Research Foundation for Mental Hygiene, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York State Psychiatric Institute | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24488838 | Derived | Steinglass JE, Albano AM, Simpson HB, Wang Y, Zou J, Attia E, Walsh BT. Confronting fear using exposure and response prevention for anorexia nervosa: A randomized controlled pilot study. Int J Eat Disord. 2014 Mar;47(2):174-80. doi: 10.1002/eat.22214. Epub 2013 Nov 8. | |
| 20570701 | Derived | Steinglass JE, Sysko R, Mayer L, Berner LA, Schebendach J, Wang Y, Chen H, Albano AM, Simpson HB, Walsh BT. Pre-meal anxiety and food intake in anorexia nervosa. Appetite. 2010 Oct;55(2):214-8. doi: 10.1016/j.appet.2010.05.090. Epub 2010 Jun 4. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Cognitive behavioral therapy (CBT) | Behavioral | 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. |
|
| 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 |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D000856 | Anorexia Nervosa |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D055502 | Secondary Prevention |
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D015980 | Public Health Practice |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided