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CompletedNCT00601822Updated Apr 10, 2012

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

A Phase 1 interventional study of Cognitive remediation therapy (CRT) and Cognitive behavioral therapy (CBT) in Anorexia Nervosa, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-04-10.

Sponsored by Stanford University · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Anorexia Nervosa
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In context

Anorexia

411 studies on the registry are indexed under Anorexia; 67 are open to participants now.

This study's enrollment of 46 is above the median of 41 across 287 interventional studies indexed under Anorexia.

Browse Anorexia studies →

Lead sponsor

Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
46 participants (actual)

Study arms

  • Experimental
    1

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

    Behavioral: Cognitive behavioral therapy (CBT)

  • Experimental
    2

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

    Behavioral: Cognitive remediation therapy (CRT) · Behavioral: Cognitive behavioral therapy (CBT)

Interventions

  • BehavioralCognitive remediation therapy (CRT)

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

  • BehavioralCognitive 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.

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What researchers measure

Primary outcomes

  1. Length of time to discontinue treatment (attrition rate)

    Time frame: Measured at Month 6

Secondary outcomes

  1. Changes in general cognitive processes and those related to anorexia nervosa

    Time frame: Measured at Month 6

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Study locations

1 site
  • Stanford University
    Stanford, California 94305, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 10, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00601822
Lead sponsor
Stanford University
Collaborators
National Institute of Mental Health (NIMH)
Responsible party
Sponsor
First posted
Jan 28, 2008
Start date
Jan 2008
Primary completion
Dec 2011
Completion
Dec 2011
Last update
Apr 10, 2012

Study contacts

James D. Lock, MD, PhD
principal investigator · Stanford University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

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