OsteoArthritis and Therapy for Sleep

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

327 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2020-11-30

Brief Summary

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Osteoarthritis (OA) pain affects 50 percent of older adults, more than half of whom also experience significant sleep disturbance. This randomized trial will determine whether a telephone-based cognitive behavioral treatment targeting insomnia in older adults with chronic severe OA-related insomnia and pain results in substantially greater reductions in insomnia severity and in related improvements in pain, fatigue, mood, quality of life and healthcare costs compared to telephone-delivered education (attention control) about insomnia. The trial will test an intervention that if demonstrated to have long term efficacy is scalable and has the potential for wide-scale deployment in healthcare systems.

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Detailed Description

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Twenty-five percent of older adults experience significant osteoarthritis (OA)-related comorbid sleep disturbance. Insomnia is associated with substantial negative effects on function, mood, and medical resource utilization. Cognitive behavioral therapy for insomnia (CBT-I) is evidence based and has been shown to be efficacious in populations with a variety of comorbid conditions including OA-related chronic pain. However, in-person CBT interventions are unlikely to be widely deployable in healthcare systems. Telephone delivery has the advantage of giving patients access to personalized, efficacious CBT-I interventions from home, increasing generalizability, and outreach to minority, rural, and other underserved populations. Older (60+ yrs) primary care patients across Washington State will be screened for severe persistent OA-related insomnia and pain. Two hundred and seventy patients will be randomized to either CBT-I or an education only attention control (EOC). Each treatment will consist of six 20-30 minute telephone-based sessions over an eight week period. Pre-treatment, post-treatment (2 months and 12 month) assessments will include measures of sleep, pain, fatigue, mood, and quality of life. A cost effectiveness evaluation of the intervention will also be conducted. The proposed research will determine if telephone CBT-I improves OA insomnia and associated outcomes in a state-wide primary care population of older adults, and inform policy decisions about widespread dissemination of telephone CBT-I in this and related patient populations.

Conditions

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Insomnia Related to Osteoarthritis Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Cognitive Behavioral Therapy

Cognitive Behavioral Therapy for Insomnia is delivered by trained sleep therapists in six telephone sessions.

Group Type EXPERIMENTAL

Cognitive Behavior Therapy for Insomnia

Intervention Type BEHAVIORAL

Six telephone sessions that last 20-30 minutes presenting cognitive behavioral therapy for insomnia.

Education Control

Education Only Control is delivered by trained sleep therapists in six telephone sessions.

Group Type ACTIVE_COMPARATOR

Education Only Control

Intervention Type BEHAVIORAL

Six telephone sessions that last 20-30 minutes presenting sleep and osteoarthritis education.

Interventions

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Cognitive Behavior Therapy for Insomnia

Six telephone sessions that last 20-30 minutes presenting cognitive behavioral therapy for insomnia.

Intervention Type BEHAVIORAL

Education Only Control

Six telephone sessions that last 20-30 minutes presenting sleep and osteoarthritis education.

Intervention Type BEHAVIORAL

Other Intervention Names

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CBT-I EOC

Eligibility Criteria

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Inclusion Criteria

* Age 60+ with one or more health care visits for OA in the prior 3 years
* Score of ≥6 on 4-item ISI at first screening and ≥11 on full ISI at second screening
* Score of ≥9 on two items from the Brief Pain Inventory (BPI) asking about average pain intensity in the past 2 weeks (0-10 scale) and activity interference due to pain (0-10 scale) at first and second screening

Exclusion Criteria

* Not continuously enrolled at Group Health Cooperative for at least one year
* Prior diagnosis of a primary sleep disorder: sleep apnea with an AHI/RDI score of 15+ or current use of a CPAP machine; periodic leg movement disorder; restless leg syndrome; sleep-wake cycle disturbance; or rapid eye movement behavior disorder
* Diagnosis in the medical record of: rheumatoid arthritis, terminal disease, being considered for major surgery, active chemotherapy or radiation for cancer, or inpatient treatment for congestive heart failure within the previous 6 months
* Diagnosis of dementia, use of acetylcholinesterase inhibitor and/or memantine for cognitive impairment, or cognitive impairment (\>6 on the Short Orientation-Memory-Concentration Test)
* Hearing or speech impairment sufficient to preclude participation in a telephone intervention

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No