Effectiveness of Cognitive Remediation Therapy in Improving Treatment Retention in People With Anorexia Nervosa
Primary Purpose
Anorexia Nervosa
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cognitive remediation therapy (CRT)
Cognitive behavioral therapy (CBT)
Sponsored by
About this trial
This is an interventional treatment trial for Anorexia Nervosa
Eligibility Criteria
Inclusion Criteria:
- Meets diagnostic criteria for AN
- Medically stable for outpatient treatment. More information on this can be found in the protocol.
- English literacy
Exclusion Criteria:
- Current psychotic illness
- History of significant brain injury
- Current dependence on drugs or alcohol
- Physical conditions (e.g., diabetes mellitus, pregnancy) known to influence eating or weight
- Previously received CBT or CRT for AN (using the same treatment models as in the study)
- Ideal body weight of less than 75%
- Taking psychotropic medications (antidepressants and antipsychotics) unless on a stable dose for 2 months prior to study entry
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
Group receiving cognitive behavioral therapy for anorexia nervosa (CBT-AN)
Group receiving cognitive behavioral therapy for anorexia nervosa, plus cognitive remediation therapy (CBT-AN+CRT)
Outcomes
Primary Outcome Measures
Length of time to discontinue treatment (attrition rate)
Secondary Outcome Measures
Changes in general cognitive processes and those related to anorexia nervosa
Full Information
NCT ID
NCT00601822
First Posted
January 4, 2008
Last Updated
April 9, 2012
Sponsor
Stanford University
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00601822
Brief Title
Effectiveness of Cognitive Remediation Therapy in Improving Treatment Retention in People With Anorexia Nervosa
Official Title
Cognitive Remediation Therapy for Anorexia Nervosa
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will evaluate the effectiveness of adding cognitive remediation therapy to cognitive behavioral therapy for treating people with anorexia nervosa.
Detailed Description
Anorexia nervosa (AN) is a serious and often chronic eating disorder characterized by low body weight and an obsessive fear of weight gain. People with AN usually try to control body weight by purging, excessive exercise, and/or restrictive eating to near starvation. These dangerous habits and the resultant weight loss in people with AN can lead to serious health complications, including anemia, osteoporosis, and kidney and heart problems. While there is no one known cause for AN, it is believed that a number of psychological, sociological, and neurobiological factors may contribute. Currently, there are no psychological or medication-based treatments known to be highly effective in treating adults with AN. This lack of treatment success may be due to the low retention rates present in AN treatment programs. Cognitive remediation therapy (CRT), a type of psychotherapy that concentrates on improving memory and cognitive flexibility, may be helpful in improving AN treatment adherence. This study will evaluate the effectiveness of adding CRT to cognitive behavioral therapy (CBT) for improving treatment retention rates and for treating people with AN.
Participation in this study will last 1 year and will consist of 6 months of treatment and one follow-up session at 6 months post-treatment. All participants will first undergo baseline assessments, which include interviews and questionnaires about psychological history and AN symptoms, an Eating Disorder Examination (EDE) interview, and a variety of cognitive tests. The questionnaires and cognitive tests will be repeated various times throughout treatment. After baseline assessments, participants will be randomly assigned to receive CBT specifically tailored for AN with or without CRT. Participants assigned to the CBT-only group will receive 28 weekly sessions of CBT with a therapist. Participants assigned to the CBT plus CRT group will receive 8 sessions of CRT and 20 sessions of CBT with a therapist. At each therapy session, participants will have their vital signs checked. In addition, participants will have blood drawn to measure electrolyte levels at baseline and every month during treatment. An electrocardiogram (EKG) will also be taken at baseline and Months 3 and 6. All baseline assessments will be repeated 6 months after the completion of treatment.
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
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Group receiving cognitive behavioral therapy for anorexia nervosa (CBT-AN)
Arm Title
2
Arm Type
Experimental
Arm Description
Group receiving cognitive behavioral therapy for anorexia nervosa, plus cognitive remediation therapy (CBT-AN+CRT)
Intervention Type
Behavioral
Intervention Name(s)
Cognitive remediation therapy (CRT)
Intervention Description
CRT includes eight sessions over 6 months that aim to improve cognitive flexibility and strengthen thinking skills.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy (CBT)
Intervention Description
CBT includes 20 to 28 weekly psychotherapy sessions over 6 months, depending on treatment group assignment. CBT sessions aim to change participants' beliefs and behaviors toward eating disorders and to teach ways to handle the daily struggles of an eating disorder.
Primary Outcome Measure Information:
Title
Length of time to discontinue treatment (attrition rate)
Time Frame
Measured at Month 6
Secondary Outcome Measure Information:
Title
Changes in general cognitive processes and those related to anorexia nervosa
Time Frame
Measured at Month 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Meets diagnostic criteria for AN
Medically stable for outpatient treatment. More information on this can be found in the protocol.
English literacy
Exclusion Criteria:
Current psychotic illness
History of significant brain injury
Current dependence on drugs or alcohol
Physical conditions (e.g., diabetes mellitus, pregnancy) known to influence eating or weight
Previously received CBT or CRT for AN (using the same treatment models as in the study)
Ideal body weight of less than 75%
Taking psychotropic medications (antidepressants and antipsychotics) unless on a stable dose for 2 months prior to study entry
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James D. Lock, MD, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Cognitive Remediation Therapy in Improving Treatment Retention in People With Anorexia Nervosa
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