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

New York State Psychiatric Institute

Status: Completed

Conditions: Anorexia Nervosa

Treatments: Behavioral: Exposure Therapy for AN (AN-EX/RP); Behavioral: Cognitive Remediation Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01174602

1R01MH082736-01 (U.S. NIH Grant/Contract)

6010

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 16 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Exposure Therapy for AN (AN-EX/RP)

Experimental group

Description:

Exposure Therapy and Ritual Prevention (AN-EX/RP) includes 12 sessions of confronting feared eating situations without the use of anxiety reducing behaviors.

Treatment:

Behavioral: Exposure Therapy for AN (AN-EX/RP)

Cognitive Remediation Therapy

Active Comparator group

Description:

Cognitive Remediation Therapy (CRT)

Treatment:

Behavioral: Cognitive Remediation Therapy