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

Primary Purpose

Anorexia Nervosa

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exposure Therapy for AN (AN-EX/RP)
Cognitive Remediation Therapy
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa

Eligibility Criteria

16 Years - 45 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exposure Therapy for AN (AN-EX/RP)

Cognitive Remediation Therapy

Arm Description

Exposure 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 (CRT)

Outcomes

Primary Outcome Measures

Eating Behavior
Eating behavior will be measured as both intake patterns in food records and in a laboratory based meal.

Secondary Outcome Measures

Psychological Improvement
The impact of these interventions on psychological state, including anxiety and thinking patterns, will be measured.
Psychological Improvement
The impact of these interventions on psychological state, including anxiety and thinking patterns, will be measured.
Eating Behavior
Laboratory meal after crossover condition.

Full Information

First Posted
July 29, 2010
Last Updated
January 28, 2015
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH), National Alliance for Research on Schizophrenia and Depression, The Hilda & Preston Davis Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01174602
Brief Title
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

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH), National Alliance for Research on Schizophrenia and Depression, The Hilda & Preston Davis Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exposure Therapy for AN (AN-EX/RP)
Arm Type
Experimental
Arm Description
Exposure Therapy and Ritual Prevention (AN-EX/RP) includes 12 sessions of confronting feared eating situations without the use of anxiety reducing behaviors.
Arm Title
Cognitive Remediation Therapy
Arm Type
Active Comparator
Arm Description
Cognitive Remediation Therapy (CRT)
Intervention Type
Behavioral
Intervention Name(s)
Exposure Therapy for AN (AN-EX/RP)
Intervention Description
12 Sessions, 3 times per week. 90 minute sessions. Group therapy twice per week.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Remediation Therapy
Intervention Description
12 Sessions, 3 times per week. 45 minute sessions. Group therapy twice per week.
Primary Outcome Measure Information:
Title
Eating Behavior
Description
Eating behavior will be measured as both intake patterns in food records and in a laboratory based meal.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Psychological Improvement
Description
The impact of these interventions on psychological state, including anxiety and thinking patterns, will be measured.
Time Frame
4 weeks
Title
Psychological Improvement
Description
The impact of these interventions on psychological state, including anxiety and thinking patterns, will be measured.
Time Frame
8 weeks
Title
Eating Behavior
Description
Laboratory meal after crossover condition.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: DSM-IV-TR™ 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanna Steinglass, MD
Organizational Affiliation
NYSPI
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

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

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