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

NCT ID: NCT00601822

Last Updated: 2012-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2011-12-31

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.

Conditions

Anorexia Nervosa

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group receiving cognitive behavioral therapy for anorexia nervosa (CBT-AN)

Group Type: EXPERIMENTAL

Cognitive behavioral therapy (CBT)

Intervention Type: BEHAVIORAL

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.

2

Group receiving cognitive behavioral therapy for anorexia nervosa, plus cognitive remediation therapy (CBT-AN+CRT)

Group Type: EXPERIMENTAL

Cognitive remediation therapy (CRT)

Intervention Type: BEHAVIORAL

CRT includes eight sessions over 6 months that aim to improve cognitive flexibility and strengthen thinking skills.

Cognitive behavioral therapy (CBT)

Intervention Type: BEHAVIORAL

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.

Interventions

Cognitive remediation therapy (CRT)

CRT includes eight sessions over 6 months that aim to improve cognitive flexibility and strengthen thinking skills.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James D. Lock, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Stanford, California, United States

Countries

United States

Other Identifiers

R01MH082706

Identifier Type: NIH

Identifier Source: secondary_id

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98328

Identifier Type: -

Identifier Source: secondary_id

DATR A2-AID

Identifier Type: -

Identifier Source: secondary_id

R01MH082706

Identifier Type: NIH

Identifier Source: org_study_id

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