Clinical trial NCT01174602: Inpatient Exposure Therapy and Response Prevention & Cognitive Remediation Therapy for Anorexia Nervosa
Official title: Randomized Controlled Trial of Inpatient Exposure Therapy and Response Prevention for Anorexia Nervosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anorexia Nervosa
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: National Alliance for Research on Schizophrenia and Depression
name: The Hilda & Preston Davis Foundation
First posted: 2010-08-03
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Eating Behavior
timeFrame: 4 weeks
Secondary outcomes:
measure: Psychological Improvement
timeFrame: 4 weeks
measure: Psychological Improvement
timeFrame: 8 weeks
measure: Eating Behavior
timeFrame: 8 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: NYSPI
name: Joanna Steinglass, MD
role: PRINCIPAL_INVESTIGATOR
References: