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

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

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

Study Overview

• Status: Completed
• Conditions: Anorexia Nervosa
• Intervention / Treatment: Behavioral: Exposure Therapy for AN (AN-EX/RP); Behavioral: Cognitive Remediation Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • New York State Psychiatric Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eating Behavior	Eating behavior will be measured as both intake patterns in food records and in a laboratory based meal.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychological Improvement	The impact of these interventions on psychological state, including anxiety and thinking patterns, will be measured.	4 weeks
Psychological Improvement	The impact of these interventions on psychological state, including anxiety and thinking patterns, will be measured.	8 weeks
Eating Behavior	Laboratory meal after crossover condition.	8 weeks

Collaborators and Investigators

• Sponsor: New York State Psychiatric Institute
• Collaborators: National Institute of Mental Health (NIMH); National Alliance for Research on Schizophrenia and Depression; The Hilda & Preston Davis Foundation
• Investigators: Principal Investigator: Joanna Steinglass, MD, NYSPI

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: July 29, 2010
• First Submitted That Met QC Criteria: August 2, 2010
• First Posted (Estimate): August 3, 2010

Study Record Updates

• Last Update Posted (Estimate): January 29, 2015
• Last Update Submitted That Met QC Criteria: January 28, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Anorexia; Anorexia Nervosa
• Other Study ID Numbers: 6010; 1R01MH082736-01 (U.S. NIH Grant/Contract)