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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01174602
Enrollment
40
Registered
2010-08-03
Start date
2009-11-30
Completion date
2014-10-31
Last updated
2015-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anorexia Nervosa

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.

Interventions

BEHAVIORALExposure Therapy for AN (AN-EX/RP)

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

BEHAVIORALCognitive Remediation Therapy

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

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Eating Behavior4 weeksEating behavior will be measured as both intake patterns in food records and in a laboratory based meal.

Secondary

MeasureTime frameDescription
Psychological Improvement4 weeksThe impact of these interventions on psychological state, including anxiety and thinking patterns, will be measured.
Eating Behavior8 weeksLaboratory meal after crossover condition.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026