Lifestyles: Cognitive Behavioral Therapy for Arthritis Pain and Insomnia in Older Adults
Study Details
Study Description
Brief Summary
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. The investigators 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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 the investigators will 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 the investigators will also ask them to let us collect some information from their GHC medical records.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Lifestyles A Cognitive Behavioral Therapy for Pain and Insomnia |
Behavioral: Lifestyles A
Six weekly group sessions that last about 90-120 minutes presenting cognitive behavioral therapy for pain and insomnia
|
| Experimental: Lifestyle B Cognitive Behavioral Therapy for Pain |
Behavioral: Lifestyles B
Six weekly group sessions that last about 90-120 minutes presenting cognitive behavioral therapy for pain.
|
| Active Comparator: Lifestyles C Osteoarthritis Education |
Behavioral: Lifestyles C
Six weekly group sessions that last about 90-120 minutes presenting osteoarthritis education.
|
Outcome Measures
Primary Outcome Measures
- Insomnia Severity Index (ISI) [Baseline]
A 7-item self-report screening measure that rates severity of sleep problems, interference with daily functioning, and participant distress over symptoms. Rated on a scale from 0 (no problems) to 4 (very much a problem).
- Insomnia Severity Index (ISI) [Post treatment- 2 months post baseline assessment]
A 7-item self-report screening measure that rates severity of sleep problems, interference with daily functioning, and participant distress over symptoms. Rated on a scale from 0 (no problems) to 4 (very much a problem).
- Insomnia Severity Index (ISI) [9 months post baseline assessment]
A 7-item self-report screening measure that rates severity of sleep problems, interference with daily functioning, and participant distress over symptoms. Rated on a scale from 0 (no problems) to 4 (very much a problem).
- Insomnia Severity Index (ISI) [18 months post baseline assessment]
A 7-item self-report screening measure that rates severity of sleep problems, interference with daily functioning, and participant distress over symptoms. Rated on a scale from 0 (no problems) to 4 (very much a problem).
- Global Pain Severity-Graded Chronic Pain Scale [Baseline]
The Global Pain Severity Scale derived from the Graded Chronic Pain Scale consists of three 0-10 pain intensity ratings (pain right now, average pain, and worst pain in the prior month) and three 0-10 pain interference ratings (interference with daily activities, recreational, social and family activites, and ability to work including housework).
- Global Pain Severity-Graded Chronic Pain Scale [Post treatment-2 mos. post baseline]
The Global Pain Severity Scale derived from the Graded Chronic Pain Scale consists of three 0-10 pain intensity ratings (pain right now, average pain, and worst pain in the prior month) and three 0-10 pain interference ratings (interference with daily activities, recreational, social and family activites, and ability to work including housework).
- Global Pain Severity-Graded Chronic Pain Scale [9 months post baseline assessment]
The Global Pain Severity Scale derived from the Graded Chronic Pain Scale consists of three 0-10 pain intensity ratings (pain right now, average pain, and worst pain in the prior month) and three 0-10 pain interference ratings (interference with daily activities, recreational, social and family activites, and ability to work including housework).
- Global Pain Severity- Graded Chronic Pain Scale [18 months post baseline assessment]
The Global Pain Severity Scale derived from the Graded Chronic Pain Scale consists of three 0-10 pain intensity ratings (pain right now, average pain, and worst pain in the prior month) and three 0-10 pain interference ratings (interference with daily activities, recreational, social and family activites, and ability to work including housework).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age 60+
-
Continuously enrolled in Group Health one year prior to sample pull
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Primary care clinic at selected clinics
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Not in "No Contact File"
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Diagnosis 715xx (Osteoarthritis) in prior three years
Exclusion Criteria:
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Not continuously enrolled in Group Health for at least one year
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Medical record information indicates a diagnosis of:
-
rheumatoid arthritis
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obstructive sleep apnea
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periodic leg movement disorder
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restless leg syndrome
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sleep-wake cycle disturbance
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rapid eye movement (REM) behavior disorder
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dementia or receiving cholinesterase inhibitors
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Parkinson's disease or other neurodegenerative disease known to directly impact sleep
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cancer in the past year and receiving chemotherapy or radiation therapy in the past year
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inpatient treatment for congestive heart failure within the previous 6 months
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Group Health Research Institute | Seattle | Washington | United States | 98101 |
| 2 | University of Washington | Seattle | Washington | United States | 98115 |
Sponsors and Collaborators
- University of Washington
- Kaiser Permanente
Investigators
- Principal Investigator: Michael V Vitiello, Ph.D., University of Washington
- Principal Investigator: Susan M McCurry, Ph.D., University of Washington
- Principal Investigator: Michael Von Korff, Sc.D., Group Health Research Institute
- Principal Investigator: Ben Balderson, Ph.D., Group Health Research Institute
Study Documents (Full-Text)
None provided.More Information
Publications
- Moffitt PF, Kalucy EC, Kalucy RS, Baum FE, Cooke RD. Sleep difficulties, pain and other correlates. J Intern Med. 1991 Sep;230(3):245-9.
- Montgomery P, Dennis J. Cognitive behavioural interventions for sleep problems in adults aged 60+. Cochrane Database Syst Rev. 2002;(2):CD003161. Review. Update in: Cochrane Database Syst Rev. 2003;(1):CD003161.
- Rybarczyk B, Stepanski E, Fogg L, Lopez M, Barry P, Davis A. A placebo-controlled test of cognitive-behavioral therapy for comorbid insomnia in older adults. J Consult Clin Psychol. 2005 Dec;73(6):1164-74.
- Smith MT, Edwards RR, McCann UD, Haythornthwaite JA. The effects of sleep deprivation on pain inhibition and spontaneous pain in women. Sleep. 2007 Apr;30(4):494-505.
- Smith MT, Haythornthwaite JA. How do sleep disturbance and chronic pain inter-relate? Insights from the longitudinal and cognitive-behavioral clinical trials literature. Sleep Med Rev. 2004 Apr;8(2):119-32. Review.
- R01AG031126
- R01AG031126