OsteoArthritis and Therapy for Sleep
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Insomnia Sleep Studies, Osteoarthritis (OA) |
| Therapuetic Areas: | Psychiatry / Psychology, Rheumatology |
| Healthy: | No |
| Age Range: | 60 - Any |
| Updated: | 12/21/2018 |
| Start Date: | October 2016 |
| End Date: | November 2020 |
Efficacy of Scalable CBT for Insomnia in Older Adults With Osteoarthritis Pain
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.
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.
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.
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.
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
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