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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Alliance for Research on Schizophrenia and Depression
The Hilda & Preston Davis Foundation
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01174602
First received: July 29, 2010
Last updated: October 24, 2012
Last verified: October 2012
  Purpose

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


Condition Intervention
Anorexia Nervosa
Behavioral: Exposure Therapy for AN (AN-EX/RP)
Behavioral: Cognitive Remediation Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Inpatient Exposure Therapy and Response Prevention for Anorexia Nervosa

Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Eating Behavior [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Eating behavior will be measured as both intake patterns in food records and in a laboratory based meal.


Secondary Outcome Measures:
  • Psychological Improvement [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The impact of these interventions on psychological state, including anxiety and thinking patterns, will be measured.

  • Psychological Improvement [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    The impact of these interventions on psychological state, including anxiety and thinking patterns, will be measured.

  • Eating Behavior [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Laboratory meal after crossover condition.


Estimated Enrollment: 30
Study Start Date: November 2009
Estimated Study Completion Date: October 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exposure Therapy for AN (AN-EX/RP)
Exposure Therapy and Ritual Prevention (AN-EX/RP) includes 12 sessions of confronting feared eating situations without the use of anxiety reducing behaviors.
Behavioral: Exposure Therapy for AN (AN-EX/RP)
12 Sessions, 3 times per week. 90 minute sessions. Group therapy twice per week.
Active Comparator: Cognitive Remediation Therapy
Cognitive Remediation Therapy (CRT)
Behavioral: Cognitive Remediation Therapy
12 Sessions, 3 times per week. 45 minute sessions. Group therapy twice per week.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   16 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. DSM-IV-TR™ diagnosis of anorexia nervosa (restricting or binge-purge subtype), with or without amenorrhea at the time of inpatient admission
  2. Subjects will have achieved 85% of ideal body weight (IBW)
  3. Age 16-45 years
  4. No acute medical condition
  5. 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:

  1. Psychotic or bipolar I disorder
  2. Substance abuse or dependence in the last 6 months
  3. Current Axis I disorder requiring psychotropic medication (ongoing antidepressant treatment for stable comorbid conditions will be allowed)
  4. Significant co-morbid depression
  5. 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.
  6. Active suicidal intent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01174602

Locations
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
National Alliance for Research on Schizophrenia and Depression
The Hilda & Preston Davis Foundation
Investigators
Principal Investigator: Joanna Steinglass, MD NYSPI
  More Information

No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01174602     History of Changes
Other Study ID Numbers: 6010, 1R01MH082736-01
Study First Received: July 29, 2010
Last Updated: October 24, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Eating Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 20, 2014