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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00627341
First received: February 28, 2008
Last updated: May 10, 2012
Last verified: May 2012

February 28, 2008
May 10, 2012
December 2007
December 2010   (final data collection date for primary outcome measure)
Diet Energy Density and Variety score [ Time Frame: Measured before treatment and at Months 1, 2, 3, 4, 5, and 6 ] [ Designated as safety issue: No ]
  • Diet Energy Density score [ Time Frame: Measured before treatment and at Months 1, 2, 3, 4, 5, and 6 ] [ Designated as safety issue: No ]
  • Diet Variety score [ Time Frame: Measured before treatment and at Months 1, 2, 3, 4, 5, and 6 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00627341 on ClinicalTrials.gov Archive Site
  • Yale-Brown-Cornell Obsessive-Compulsive Scale for Eating Disorders (YBC-EDS) score [ Time Frame: Measured before treatment and at Months 3 and 6 ] [ Designated as safety issue: No ]
  • Body mass index (BMI) [ Time Frame: Measured weekly for 6 months ] [ Designated as safety issue: No ]
  • Amount consumed at test meals [ Time Frame: Measured two times before treatment and two times after Month 6 ] [ Designated as safety issue: No ]
  • Reported levels of anxiety at test meals [ Time Frame: Measured two times before treatment and two times after Month 6 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Relapse Prevention Program for Reducing Relapse and Fear of Food in People With Anorexia Nervosa
Addressing Fear of Food in Anorexia Nervosa

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Eating Disorders
  • 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.
  • Behavioral: 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.
  • Experimental: Exposure and Response Prevention
    Participants will receive Food Exposure Therapy and Ritual Prevention with Motivational Enhancement for Relapse Prevention in Anorexia Nervosa for 6 months.
    Intervention: Behavioral: Food Exposure Therapy and Ritual Prevention with Motivational Enhancement for Relapse Prevention in Anorexia Nervosa (AN-EX/RP)
  • Active Comparator: Cognitive Behavior Therapy
    Participants will receive cognitive behavioral therapy for anorexia nervosa for 6 months.
    Intervention: Behavioral: Cognitive behavioral therapy (CBT)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
16 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00627341
#5593, R01MH082736, DATR A2-AID
No
New York State Psychiatric Institute
New York State Psychiatric Institute
National Institute of Mental Health (NIMH)
Principal Investigator: Joanna E. Steinglass, MD Research Foundation for Mental Hygiene, Inc.
New York State Psychiatric Institute
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP