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
2 other identifiers
interventional
40
1 country
1
Brief Summary
Exposure and response prevention (AN-EXRP) will help individuals with anorexia nervosa improve their eating behavior.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 29, 2010
CompletedFirst Posted
Study publicly available on registry
August 3, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedJanuary 29, 2015
January 1, 2015
1.9 years
July 29, 2010
January 28, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Eating Behavior
Eating behavior will be measured as both intake patterns in food records and in a laboratory based meal.
4 weeks
Secondary Outcomes (3)
Psychological Improvement
4 weeks
Psychological Improvement
8 weeks
Eating Behavior
8 weeks
Study Arms (2)
Exposure Therapy for AN (AN-EX/RP)
EXPERIMENTALExposure Therapy and Ritual Prevention (AN-EX/RP) includes 12 sessions of confronting feared eating situations without the use of anxiety reducing behaviors.
Cognitive Remediation Therapy
ACTIVE COMPARATORCognitive Remediation Therapy (CRT)
Interventions
12 Sessions, 3 times per week. 90 minute sessions. Group therapy twice per week.
12 Sessions, 3 times per week. 45 minute sessions. Group therapy twice per week.
Eligibility Criteria
You may qualify if:
- DSM-IV-TRâ„¢ diagnosis of anorexia nervosa (restricting or binge-purge subtype), with or without amenorrhea at the time of inpatient admission
- Subjects will have achieved 85% of ideal body weight (IBW)
- Age 16-45 years
- No acute medical condition
- 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.
You may not qualify if:
- Psychotic or bipolar I disorder
- Substance abuse or dependence in the last 6 months
- Current Axis I disorder requiring psychotropic medication (ongoing antidepressant treatment for stable comorbid conditions will be allowed)
- Significant co-morbid depression
- 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.
- Active suicidal intent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York State Psychiatric Institute
New York, New York, 10032, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joanna Steinglass, MD
NYSPI
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2010
First Posted
August 3, 2010
Study Start
November 1, 2009
Primary Completion
October 1, 2011
Study Completion
October 1, 2014
Last Updated
January 29, 2015
Record last verified: 2015-01