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

NCT ID: NCT01174602

Last Updated: 2015-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2014-10-31

Brief Summary

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

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.

Conditions

Anorexia Nervosa

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Exposure Therapy for AN (AN-EX/RP)

Intervention Type: BEHAVIORAL

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

Cognitive Remediation Therapy

Cognitive Remediation Therapy (CRT)

Group Type: ACTIVE_COMPARATOR

Cognitive Remediation Therapy

Intervention Type: BEHAVIORAL

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

Interventions

Exposure Therapy for AN (AN-EX/RP)

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

Intervention Type: BEHAVIORAL

Cognitive Remediation Therapy

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

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

National Alliance for Research on Schizophrenia and Depression

OTHER

Sponsor Role: collaborator

The Hilda & Preston Davis Foundation

OTHER

Sponsor Role: collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joanna Steinglass, MD

Role: PRINCIPAL_INVESTIGATOR

NYSPI

Locations

New York State Psychiatric Institute

New York, New York, United States

Countries

United States

Other Identifiers

1R01MH082736-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

6010

Identifier Type: -

Identifier Source: org_study_id