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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00601822
First received: January 4, 2008
Last updated: April 9, 2012
Last verified: April 2012
  Purpose

This study will evaluate the effectiveness of adding cognitive remediation therapy to cognitive behavioral therapy for treating people with anorexia nervosa.


Condition Intervention Phase
Anorexia Nervosa
Behavioral: Cognitive remediation therapy (CRT)
Behavioral: Cognitive behavioral therapy (CBT)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cognitive Remediation Therapy for Anorexia Nervosa

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Length of time to discontinue treatment (attrition rate) [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in general cognitive processes and those related to anorexia nervosa [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: January 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Group receiving cognitive behavioral therapy for anorexia nervosa (CBT-AN)
Behavioral: Cognitive behavioral therapy (CBT)
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.
Experimental: 2
Group receiving cognitive behavioral therapy for anorexia nervosa, plus cognitive remediation therapy (CBT-AN+CRT)
Behavioral: Cognitive remediation therapy (CRT)
CRT includes eight sessions over 6 months that aim to improve cognitive flexibility and strengthen thinking skills.
Behavioral: Cognitive behavioral therapy (CBT)
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00601822

Locations
United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: James D. Lock, MD, PhD Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00601822     History of Changes
Other Study ID Numbers: R01 MH082706, R01MH082706, 98328, DATR A2-AID
Study First Received: January 4, 2008
Last Updated: April 9, 2012
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Eating Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 20, 2014