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

Anorexia Nervosa Clinical Trial

Official title:

Cognitive Remediation Therapy for Anorexia Nervosa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00601822
• Other study ID #: R01MH082706
• Secondary ID: R01MH08270698328
• Status: Completed
• Phase: Phase 1
• First received: January 4, 2008
• Last updated: April 9, 2012
• Start date: January 2008
• Est. completion date: December 2011

Study information

• Verified date: April 2012
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

Behavioral:
• Cognitive remediation therapy (CRT)
CRT includes eight sessions over 6 months that aim to improve cognitive flexibility and strengthen thinking skills.
• 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.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of time to discontinue treatment (attrition rate)		Measured at Month 6	No
Secondary	Changes in general cognitive processes and those related to anorexia nervosa		Measured at Month 6	No