Inpatient Exposure Therapy and Response Prevention & Cognitive Remediation Therapy for Anorexia Nervosa
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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 |
- 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.
- 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 |
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
Contacts and Locations| United States, New York | |
| New York State Psychiatric Institute | |
| New York, New York, United States, 10032 | |
| 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 May 19, 2013