Anorexia Nervosa Clinical Trial
Official title:
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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