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Effectiveness of Cognitive Remediation Therapy in Improving Treatment Retention in People With Anorexia Nervosa

This study is currently recruiting participants.
Information provided by National Institute of Mental Health (NIMH)

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Descriptive Information Fields
Brief Title  Effectiveness of Cognitive Remediation Therapy in Improving Treatment Retention in People With Anorexia Nervosa
Official Title  Cognitive Remediation Therapy for Anorexia Nervosa
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.

Study Phase Phase I
Study Type  Interventional
Study Design  Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Primary Outcome Measure  Length of time to discontinue treatment (attrition rate) [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ]
Secondary Outcome Measure  Changes in general cognitive processes and those related to anorexia nervosa [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ]
Condition  Anorexia Nervosa
Intervention  Behavioral: Cognitive remediation therapy (CRT)
Behavioral: Cognitive behavioral therapy (CBT)
MEDLINE PMIDs
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Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  46
Start Date  January 2008
Completion Date December 2011
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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: Judy G. Beenhakker, MS     650-723-7885     judybeen@stanford.edu    
Contact: Sarah E. Forsberg, BA     650-723-9182     sarah523@stanford.edu    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00601822
Organization ID R01 MH082706
Secondary IDs †† 98328, DATR A2-AID
Study Sponsor  National Institute of Mental Health (NIMH)
Collaborators ††
Investigators 
Principal Investigator:     James D. Lock, MD, PhD     Stanford University    
Information Provided By National Institute of Mental Health (NIMH)
Verification Date August 2008
First Received Date  January 4, 2008
Last Updated Date August 26, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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