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

Eating Disorders Clinical Trial

Official title:

Addressing Fear of Food in Anorexia Nervosa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00627341
• Other study ID #: #5593
• Secondary ID: R01MH082736DATR
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 28, 2008
• Last updated: May 10, 2012
• Start date: December 2007
• Est. completion date: December 2010

Study information

• Verified date: May 2012
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Eating Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diet Energy Density and Variety score		Measured before treatment and at Months 1, 2, 3, 4, 5, and 6	No
Secondary	Yale-Brown-Cornell Obsessive-Compulsive Scale for Eating Disorders (YBC-EDS) score		Measured before treatment and at Months 3 and 6	No
Secondary	Body mass index (BMI)		Measured weekly for 6 months	No
Secondary	Amount consumed at test meals		Measured two times before treatment and two times after Month 6	No
Secondary	Reported levels of anxiety at test meals		Measured two times before treatment and two times after Month 6	No