|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | January 4, 2008 | ||||||||
| Last Updated Date | March 23, 2009 | ||||||||
| Start Date ICMJE | January 2008 | ||||||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Length of time to discontinue treatment (attrition rate) [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00601822 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Changes in general cognitive processes and those related to anorexia nervosa [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Effectiveness of Cognitive Remediation Therapy in Improving Treatment Retention in People With Anorexia Nervosa | ||||||||
| Official Title ICMJE | Cognitive Remediation Therapy for Anorexia Nervosa | ||||||||
| 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. |
||||||||
| Study Phase | Phase I | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study | ||||||||
| Condition ICMJE | Anorexia Nervosa | ||||||||
| Intervention ICMJE |
|
||||||||
| Study Arms / Comparison Groups |
|
||||||||
| Publications * | |||||||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 46 | ||||||||
| Estimated Completion Date | December 2011 | ||||||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00601822 | ||||||||
| Responsible Party | James D. Lock, MD, PhD, Stanford University Child and Adolescent Psychiatry | ||||||||
| Study ID Numbers ICMJE | R01 MH082706, 98328, DATR A2-AID | ||||||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | March 2009 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||
