Clinical Trials Directory

Trials / Completed

CompletedNCT00627341

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

Addressing Fear of Food in Anorexia Nervosa

Status
Completed
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
34 (actual)
Sponsor
New York State Psychiatric Institute · Academic / Other
Sex
All
Age
16 Years – 45 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALFood 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.
BEHAVIORALCognitive 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.

Timeline

Start date
2007-12-01
Primary completion
2010-12-01
Completion
2010-12-01
First posted
2008-03-03
Last updated
2012-05-11

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00627341. Inclusion in this directory is not an endorsement.