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Completed

NCT Number: NCT00627341

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

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Key information

Age range

16 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

New York State Psychiatric Institute

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Food Exposure Therapy and Ritual Prevention with Motivational Enhancement for Relapse Prevention in Anorexia Nervosa (AN-EX/RP)

Behavioral

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)

Behavioral

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 outcomes

  1. Diet Energy Density and Variety score

    Time frame: Measured before treatment and at Months 1, 2, 3, 4, 5, and 6

Secondary outcomes

  1. Yale-Brown-Cornell Obsessive-Compulsive Scale for Eating Disorders (YBC-EDS) score

    Time frame: Measured before treatment and at Months 3 and 6

  2. Body mass index (BMI)

    Time frame: Measured weekly for 6 months

  3. Amount consumed at test meals

    Time frame: Measured two times before treatment and two times after Month 6

  4. Reported levels of anxiety at test meals

    Time frame: Measured two times before treatment and two times after Month 6

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Addressing Fear of Food in Anorexia Nervosa

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Mar 3, 2008
Registry last updated
May 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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