Cognitive Behavioral Therapy for Arthritis Pain and Insomnia in Older Adults

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Cognitive Behavioral Therapy for Arthritis Pain and Insomnia in Older Adults

Conditions
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Pain Dysfunction, Sleep Disturbance, Osteoarthritis

Intervention / Treatment
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* Behavioral: Lifestyles A
* Behavioral: Lifestyles B
* Behavioral: Lifestyles C


Participation Criteria
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Eligibility Criteria
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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: rheumatoid arthritis obstructive sleep apnea periodic leg movement disorder restless leg syndrome sleep-wake cycle disturbance rapid eye movement (REM) behavior disorder dementia or receiving cholinesterase inhibitors Parkinson's disease or other neurodegenerative disease known to directly impact sleep cancer in the past year and receiving chemotherapy or radiation therapy in the past year inpatient treatment for congestive heart failure within the previous 6 months

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyles A<br>Cognitive Behavioral Therapy for Pain and Insomnia | Behavioral: Lifestyles A<br>* Six weekly group sessions that last about 90-120 minutes presenting cognitive behavioral therapy for pain and insomnia<br>|
| Experimental: Lifestyle B<br>Cognitive Behavioral Therapy for Pain | Behavioral: Lifestyles B<br>* Six weekly group sessions that last about 90-120 minutes presenting cognitive behavioral therapy for pain.<br>|
| Active Comparator: Lifestyles C<br>Osteoarthritis Education | Behavioral: Lifestyles C<br>* Six weekly group sessions that last about 90-120 minutes presenting osteoarthritis education.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia Severity Index (ISI) | 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). | Baseline | 
| Insomnia Severity Index (ISI) | 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). | Post treatment- 2 months post baseline assessment | 
| Insomnia Severity Index (ISI) | 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). | 9 months post baseline assessment | 
| Insomnia Severity Index (ISI) | 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). | 18 months post baseline assessment | 
| Global Pain Severity-Graded Chronic Pain Scale | 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). | Baseline | 
| Global Pain Severity-Graded Chronic Pain Scale | 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). | Post treatment-2 mos. post baseline | 
| Global Pain Severity-Graded Chronic Pain Scale | 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). | 9 months post baseline assessment | 
| Global Pain Severity- Graded Chronic Pain Scale | 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). | 18 months post baseline assessment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthritis, Group Program, Pain, Insomnia, Pain dysfunction and sleep disturbance among older adults with osteoarthritis.