Clinical trial NCT00627341: A Relapse Prevention Program for Reducing Relapse and Fear of Food in People With Anorexia Nervosa
Official title: Addressing Fear of Food in Anorexia Nervosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Eating Disorders
Keywords: Exposure Therapy
Relapse Prevention
Anorexia Nervosa
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2008-03-03
Enrollment: 34
Sex: ALL
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Diet Energy Density and Variety score
timeFrame: Measured before treatment and at Months 1, 2, 3, 4, 5, and 6
Secondary outcomes:
measure: Yale-Brown-Cornell Obsessive-Compulsive Scale for Eating Disorders (YBC-EDS) score
timeFrame: Measured before treatment and at Months 3 and 6
measure: Body mass index (BMI)
timeFrame: Measured weekly for 6 months
measure: Amount consumed at test meals
timeFrame: Measured two times before treatment and two times after Month 6
measure: Reported levels of anxiety at test meals
timeFrame: Measured two times before treatment and two times after Month 6
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: Research Foundation for Mental Hygiene, Inc.
name: Joanna E. Steinglass, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.