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Cognitive Behavioral Therapy for Arthritis Pain and Insomnia in Older Adults - NCT01142349-98101(Clinical Trial 656899)



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City:  Seattle
State:  
WA
Zip Code: 98101
Conditions: Pain Dysfunction - Sleep Disturbance - Osteoarthritis
Purpose: This study compares the efficacy of three group interventions for people with co-morbid osteoarthritis (OA) and insomnia to help them manage their OA symptoms. We hypothesize that a combination cognitive-behavioral treatment will produce significantly greater initial and long-term improvements in OA symptoms than will the other two treatments.
Study summary: This study is only for members of the Group Health Cooperative (GHC) of Puget Sound who have both osteoarthritis pain and insomnia. The first part of the study involves filling out a mailed survey. Based on the results of the survey some respondents will be eligible for the second part of the study. Our goal in the second part is to test three different treatments for managing OA symptoms. The programs teach about things people with arthritis can do to improve the quality of their lives. All three programs deal with pain, sleep, mood and activity—but each has a slightly different focus. Participants will be randomly assigned to one of the three programs. Each program is made up of six weekly group sessions that last about 90-120 minutes. The programs will be co-led by licensed therapists and each will include 8-12 members. Study participants will also take part in a series of visits at their homes over the next 18 months. At each visit we'll ask them to do a few other study activities, such as keep a 7-day diary of their sleep and fill out a survey about their arthritis pain. With their permission we will also ask them to let us collect some information from their GHC medical records.
Criteria: Inclusion Criteria: - Age 60+ - Continuously enrolled in Group Health one year prior to sample pull - Primary care clinic at selected clinics - Not in "No Contact File" - Diagnosis 715xx (Osteoarthritis) in prior three years Exclusion Criteria: - Not continuously enrolled in Group Health for at least one year - Medical record information indicates a diagnosis of: 1. rheumatoid arthritis 2. obstructive sleep apnea 3. periodic leg movement disorder 4. restless leg syndrome 5. sleep-wake cycle disturbance 6. rapid eye movement (REM) behavior disorder 7. dementia or receiving cholinesterase inhibitors 8. Parkinson's disease or other neurodegenerative disease known to directly impact sleep 9. cancer in the past year and receiving chemotherapy or radiation therapy in the past year 10. inpatient treatment for congestive heart failure within the previous 6 months
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Data Source: ClinicalTrials.gov
Date Processed: December 15, 2010
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