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Completed

NCT Number: NCT01174602

Inpatient Exposure Therapy and Response Prevention & Cognitive Remediation Therapy for Anorexia Nervosa

Exposure and response prevention (AN-EXRP) will help individuals with anorexia nervosa improve their eating behavior.

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Key information

Age range

16 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York State Psychiatric Institute

New York, 10032, United States

About this study

Anorexia nervosa (AN) is a serious illness associated with substantial morbidity and a mortality rate among the highest of any psychiatric illness. The rate of relapse is disturbingly high, with up to 50% of patients requiring re-hospitalization within a year of discharge. Current treatments are inadequate in helping older adolescents and adults achieve sustained recovery. Importantly, eating behavior remains disturbed after weight restoration: patients demonstrate restrictive eating in their self-selected foods and in standardized meals, and caloric intake in standardized meals is inversely related to pre-meal anxiety. Emerging data suggest that eating behavior is particularly important in post-hospital course, and that significantly altering eating behavior is critical in improving outcome for these individuals. Furthermore, caloric intake in standardized meals has been shown to be related to pre-meal anxiety. This study evaluates the potential utility of two psychotherapeutic interventions in improving eating behavior prior to hospital discharge. Each individual receives, in random order, Cognitive Remediation Therapy for 4 weeks and Exposure and Response Prevention for AN for 4 weeks. The investigators hypothesize that these interventions will lead to improvement in eating behavior, measured by food diaries and standardized meals.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • DSM-IV-TR™ diagnosis of anorexia nervosa (restricting or binge-purge subtype), with or without amenorrhea at the time of inpatient admission
  • Subjects will have achieved 85% of ideal body weight (IBW)
  • Age 16-45 years
  • No acute medical condition
  • Subjects must have signed informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

Exclusion criteria

  • Psychotic or bipolar I disorder
  • Substance abuse or dependence in the last 6 months
  • Current Axis I disorder requiring psychotropic medication (ongoing antidepressant treatment for stable comorbid conditions will be allowed)
  • Significant co-morbid depression
  • Significant medical problems that would introduce additional risk related to research or interfere with participation, e.g. SBP>140, DBP>90, HR>100 for a sustained period.
  • Active suicidal intent

Treatment and study plan

Exposure Therapy for AN (AN-EX/RP)

Behavioral

12 Sessions, 3 times per week. 90 minute sessions. Group therapy twice per week.

Cognitive Remediation Therapy

Behavioral

12 Sessions, 3 times per week. 45 minute sessions. Group therapy twice per week.

Primary outcomes

  1. Eating Behavior

    Time frame: 4 weeks

    Eating behavior will be measured as both intake patterns in food records and in a laboratory based meal.

Secondary outcomes

  1. Psychological Improvement

    Time frame: 4 weeks

    The impact of these interventions on psychological state, including anxiety and thinking patterns, will be measured.

  2. Psychological Improvement

    Time frame: 8 weeks

    The impact of these interventions on psychological state, including anxiety and thinking patterns, will be measured.

  3. Eating Behavior

    Time frame: 8 weeks

    Laboratory meal after crossover condition.

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Collaborators

  • National Alliance for Research on Schizophrenia and Depression
  • National Institute of Mental Health (NIMH)
  • The Hilda & Preston Davis Foundation

Registry information

Official study title

Randomized Controlled Trial of Inpatient Exposure Therapy and Response Prevention for Anorexia Nervosa

Important dates

Study start
2009
Primary completion
2011
Study completion
2014
First posted
Aug 3, 2010
Registry last updated
Jan 29, 2015

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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