A Relapse Prevention Program for Reducing Relapse and Fear of Food in People With Anorexia Nervosa
Primary Purpose
Eating Disorders
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Food Exposure Therapy and Ritual Prevention with Motivational Enhancement for Relapse Prevention in Anorexia Nervosa (AN-EX/RP)
Cognitive behavioral therapy (CBT)
Sponsored by
About this trial
This is an interventional prevention trial for Eating Disorders focused on measuring Exposure Therapy, Relapse Prevention, Anorexia Nervosa
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
Sites / Locations
- New York State Psychiatric Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Exposure and Response Prevention
Cognitive Behavior Therapy
Arm Description
Participants will receive Food Exposure Therapy and Ritual Prevention with Motivational Enhancement for Relapse Prevention in Anorexia Nervosa for 6 months.
Participants will receive cognitive behavioral therapy for anorexia nervosa for 6 months.
Outcomes
Primary Outcome Measures
Diet Energy Density and Variety score
Secondary Outcome Measures
Yale-Brown-Cornell Obsessive-Compulsive Scale for Eating Disorders (YBC-EDS) score
Body mass index (BMI)
Amount consumed at test meals
Reported levels of anxiety at test meals
Full Information
NCT ID
NCT00627341
First Posted
February 28, 2008
Last Updated
May 10, 2012
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00627341
Brief Title
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
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorders
Keywords
Exposure Therapy, Relapse Prevention, Anorexia Nervosa
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exposure and Response Prevention
Arm Type
Experimental
Arm Description
Participants will receive Food Exposure Therapy and Ritual Prevention with Motivational Enhancement for Relapse Prevention in Anorexia Nervosa for 6 months.
Arm Title
Cognitive Behavior Therapy
Arm Type
Active Comparator
Arm Description
Participants will receive cognitive behavioral therapy for anorexia nervosa for 6 months.
Intervention Type
Behavioral
Intervention Name(s)
Food Exposure Therapy and Ritual Prevention with Motivational Enhancement for Relapse Prevention in Anorexia Nervosa (AN-EX/RP)
Intervention Description
AN-EX/RP will consist of in-session exposures to feared eating situations without using avoidance behaviors as well as formal motivational interviewing techniques.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy (CBT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Diet Energy Density and Variety score
Time Frame
Measured before treatment and at Months 1, 2, 3, 4, 5, and 6
Secondary Outcome Measure Information:
Title
Yale-Brown-Cornell Obsessive-Compulsive Scale for Eating Disorders (YBC-EDS) score
Time Frame
Measured before treatment and at Months 3 and 6
Title
Body mass index (BMI)
Time Frame
Measured weekly for 6 months
Title
Amount consumed at test meals
Time Frame
Measured two times before treatment and two times after Month 6
Title
Reported levels of anxiety at test meals
Time Frame
Measured two times before treatment and two times after Month 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanna E. Steinglass, MD
Organizational Affiliation
Research Foundation for Mental Hygiene, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24488838
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.
Results Reference
derived
PubMed Identifier
20570701
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.
Results Reference
derived
Learn more about this trial
A Relapse Prevention Program for Reducing Relapse and Fear of Food in People With Anorexia Nervosa
We'll reach out to this number within 24 hrs