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

April 9, 2012 updated by: Stanford University

Cognitive Remediation Therapy for Anorexia Nervosa

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 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.
Behavioral: Cognitive remediation therapy (CRT)
CRT includes eight sessions over 6 months that aim to improve cognitive flexibility and strengthen thinking skills.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Length of time to discontinue treatment (attrition rate)
Time Frame: Measured at Month 6
Measured at Month 6

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in general cognitive processes and those related to anorexia nervosa
Time Frame: Measured at Month 6
Measured at Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: James D. Lock, MD, PhD, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

January 4, 2008

First Submitted That Met QC Criteria

January 16, 2008

First Posted (Estimate)

January 28, 2008

Study Record Updates

Last Update Posted (Estimate)

April 10, 2012

Last Update Submitted That Met QC Criteria

April 9, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH082706 (U.S. NIH Grant/Contract)
  • DATR A2-AID (NIH Adult Translational Research and Treatment Development)
  • 98328

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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