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

Anorexia Nervosa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01174602
• Other study ID #: 6010
• Secondary ID: 1R01MH082736-01
• Status: Completed
• Phase: N/A
• First received: July 29, 2010
• Last updated: January 28, 2015
• Start date: November 2009
• Est. completion date: October 2014

Study information

• Verified date: January 2015
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2014
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

Behavioral:
• Exposure Therapy for AN (AN-EX/RP)
12 Sessions, 3 times per week. 90 minute sessions. Group therapy twice per week.
• Cognitive Remediation Therapy
12 Sessions, 3 times per week. 45 minute sessions. Group therapy twice per week.

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Alliance for Research on Schizophrenia and Depression, National Institute of Mental Health (NIMH), The Hilda & Preston Davis Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eating Behavior	Eating behavior will be measured as both intake patterns in food records and in a laboratory based meal.	4 weeks	No
Secondary	Psychological Improvement	The impact of these interventions on psychological state, including anxiety and thinking patterns, will be measured.	4 weeks	No
Secondary	Psychological Improvement	The impact of these interventions on psychological state, including anxiety and thinking patterns, will be measured.	8 weeks	No
Secondary	Eating Behavior	Laboratory meal after crossover condition.	8 weeks	No