OsteoArthritis and Therapy for Sleep

Study Overview
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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.

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.

Official Title
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Efficacy of Scalable CBT for Insomnia in Older Adults With Osteoarthritis Pain

Conditions
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Insomnia Related to Osteoarthritis Pain

Intervention / Treatment
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* Behavioral: Cognitive Behavior Therapy for Insomnia
* Behavioral: Education Only Control


Participation Criteria
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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

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: Cognitive Behavioral Therapy<br>Cognitive Behavioral Therapy for Insomnia is delivered by trained sleep therapists in six telephone sessions. | Behavioral: Cognitive Behavior Therapy for Insomnia<br>* Six telephone sessions that last 20-30 minutes presenting cognitive behavioral therapy for insomnia.<br>* Other names: CBT-I;|
| Active Comparator: Education Control<br>Education Only Control is delivered by trained sleep therapists in six telephone sessions. | Behavioral: Education Only Control<br>* Six telephone sessions that last 20-30 minutes presenting sleep and osteoarthritis education.<br>* Other names: EOC;|

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 questionnaire that is a global measure of perceived insomnia severity. Items use a 5-point scale for total scores of 0-28, with >15 considered moderate severity. | 12 months post baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia Severity Index (ISI) | A 7-item questionnaire that is a global measure of perceived insomnia severity.Items use a 5-point scale for total scores of 0-28, with >15 considered moderate severity. | 2 months post baseline | 
| Pittsburgh Sleep Quality Index (PSQI) | Self-rating of overall sleep quality and disturbances using 7 sleep. components. PSQI global >5 is highly sensitive and specific for distinguishing good and poor sleepers. | 2 months post baseline | 
| Pittsburgh Sleep Quality Index (PSQI) | Self-rating of overall sleep quality and disturbances using 7 sleep components. PSQI global >5 is highly sensitive and specific for distinguishing good and poor sleepers. | 12 months post baseline | 
| Brief Pain Inventory-short form (BPI-sf) | A questionnaire to assess pain intensity and interference with activities. The BPI-sf rates pain intensity (4 items) and interference (7 items) from 0 to 10 and is validated for use in clinical trials with OA pain patients. | 2 months post baseline | 
| Brief Pain Inventory-short form (BPI-sf) | A questionnaire to assess pain intensity and interference with activities. The BPI-sf rates pain intensity (4 items) and interference (7 items) from 0 to 10 and is validated for use in clinical trials with OA pain patients. | 12 months post baseline | 
| Flinders Fatigue Scale (FFS) | A 7-item self-report questionnaire to measure fatigue level in a variety of situations. | 2 months post baseline | 
| Flinders Fatigue Scale (FFS) | A 7-item self-report questionnaire to measure fatigue level in a variety of situations. | 12 months post baseline | 
| Patient Health Questionnaire (PHQ-8) | 4-point scale rates frequency of occurrence of 8 depressive symptoms. | 2 months post baseline | 
| Patient Health Questionnaire (PHQ-8) | 4-point scale rates frequency of occurrence of 8 depressive symptoms. | 12 months post baseline | 
| Sleep Hygiene Index (SHI) | A 13-item scale that rates how often participants engage in specific sleep hygiene related behaviors, including continued adherence to CBT-I recommendations over time. | 2 months post baseline | 
| Sleep Hygiene Index (SHI) | A 13-item scale that rates how often participants engage in specific sleep hygiene related behaviors, including continued adherence to CBT-I recommendations over time. | 12 months post baseline | 
| EuroQoL 5D (EQ-5D) | Rates health status on five dimensions and overall health status from 0 to 100. The most widely used measure in clinical trials assessing general quality of life of OA patients. | 2 months post baseline | 
| EuroQoL 5D (EQ-5D) | Rates health status on five dimensions and overall health status from 0 to 100. The most widely used measure in clinical trials assessing general quality of life of OA patients. | 12 months post baseline | 
| Western Ontario and McMaster Universities Arthritis Index (WOMAC) | A 24-item questionnaire rating pain, stiffness, and physical functioning in everyday activities. It is the most widely used condition-specific quality of life measure for arthritis cost-effectiveness studies. | 2 months post baseline | 
| Western Ontario and McMaster Universities Arthritis Index (WOMAC) | A 24-item questionnaire rating pain, stiffness, and physical functioning in everyday activities. It is the most widely used condition-specific quality of life measure for arthritis cost-effectiveness studies. | 12 months post baseline | 
| Use of sleep and pain medications | NSAID, analgesic, sedative, and anti-depressant medication use. | Baseline through 24 months | 
| Outpatient visits | The number of visits for OA, for sleep problems, and for visits irrespective of associated diagnosis. | Baseline through 24 months | 
| Health care costs | The Group Health cost database will be used to estimate costs (from study entry to 24 months post enrollment) of ambulatory healthcare for all conditions, arthritis and sleep problems, and inpatient care. | Baseline through 24 months |