OATS Trial: Can Phone-Based CBT Put Insomnia to Rest in Older OA Patients?

Results from the Osteoarthritis and Therapy for Sleep (OATS) study suggest that telephone-based cognitive behavioral therapy for insomnia (CBT-I) is an effective treatment for older adults with comorbid insomnia and osteoarthritis (OA), potentially opening treatment access to patients in underserved areas.

Roughly 50% of older adults suffer from OA, and more than half of these patients also experience disturbed sleep, making OA-related insomnia a common complaint in this population, Susan M. McCurry, PhD, of the School of Nursing at the University of Washington in Seattle, and colleagues explained in JAMA Internal Medicine.

And, while CBT-I is the first line treatment for insomnia, it is not widely available, “especially in medically underserved or health professional shortage areas (MU/HPSAs), and patients are rarely referred for treatment.”

McCurry and colleagues set out to assess the efficacy of CBT-I conducted via telephone for treating insomnia symptoms and important comorbidities — pain, depression, and fatigue — versus education-only controls (EOC) among patients with OA.

“Statewide provision of telephone CBT-I improved insomnia among older persons with chronic insomnia and comorbid OA pain,” McCurry and colleagues found. “Treatment effects for insomnia were large, robust, and sustained at 12-month follow-up, with comparable benefits among persons with more severe insomnia and pain symptoms at baseline. The CBT-I intervention also reduced fatigue, indicating improved daytime function. Less robust CBT-I benefits were observed for pain. Differences between the CBT-I and EOC groups for depression were modest and not consistently statistically significant, perhaps because relatively few patients had elevated baseline depression scores.”

They added that, given that approximately two-thirds of the OATS trial cohort resided in MU/HSPAs with limited access to individualized treatment, these findings have major implications beyond the present study population.

“The ongoing coronavirus disease 2019 pandemic highlights the importance of being able to deliver effective health care remotely through a modality as widely available as the telephone,” they wrote. “The OATS trial telephone CBT-I protocol is readily scalable and provides a template for accessible, individualized, and effective treatment for chronic insomnia comorbid with OA in older adult populations.”

For their analysis, the study authors recruited patients via Kaiser Permanente Washington (KPW) from September 2016 through December 2018. Recruited patients were 60 years of age or older, continuously enrolled at KPW for at least 1 year, and had a diagnosis of OA in the 3 years prior to screening — at initial telephone screening, eligible patients scored 11 or greater on the Insomnia Severity Index (ISI) and scored 9 or greater on a two-question Brief Pain Inventory-short form (BPI-sf). Patients were excluded if they had sleep disorders other than insomnia (e.g., sleep apnea), rheumatoid arthritis, active cancer, congestive heart failure, or a diagnosis of cognitive impairment.

McCurry and colleagues conducted blinded assessments at baseline, after 2 months post-treatment, and at 12-month follow-up, they explained. Participants received six 20- to 30-minute telephone sessions over a period of 8 weeks, and the cohort submitted daily diaries and received group-specific educational materials — those randomized to the CBT-I group (n=163) were given instructions including sleep restriction, stimulus control, sleep hygiene, cognitive restructuring, and homework, while those randomized to EOC (n=164) only received information about sleep and OA. Of the 327 randomized patients, the mean (standard deviation) age was 70.2 (6.8) years, 244 (74.6%) were women. Of these, 136 and 146 completed the 2-month post-treatment assessment in the CBT-I and EOC groups, respectively; 119 and 128 completed 12-month follow-up in the CBT-I and EOC groups, respectively.

The study authors noted that participants in the CBT-I group, compared to the EOC group, were more likely to be White (143 [87.7%] in the CBT-I group; 123 [75%] in the EOC group), and be college graduates (86 [52.8%] in the CBT-I group; 72 [43.9%] in the EOC group).

The primary study outcome was ISI score at 2 months post-treatment and 12-month follow-up; secondary outcomes included BPI-sf scores, depression (scored via an eight-item Patient Health Questionnaire), and fatigue (scored via the Flinders Fatigue Scale).

“In the 282 participants with follow-up ISI data, the total 2-month post-treatment ISI scores decreased 8.1 points in the CBT-I group and 4.8 points in the EOC group, an adjusted mean between-group difference of −3.5 points (95% CI, −4.4 to −2.6 points; P< 0.001),” McCurry and colleagues reported.

“Results were sustained at 12-month follow-up (adjusted mean difference, −3.0 points; 95% CI, −4.1 to −2.0 points; P< 0.001). At 12-month follow-up, 67 of 119 (56.3%) participants receiving CBT-I remained in remission (ISI score, ≤7) compared with 33 of 128 (25.8%) participants receiving EOC. Fatigue was also significantly reduced in the CBT-I group compared with the EOC group at 2 months post-treatment (mean between-group difference, −2.0 points; 95% CI, −3.1 to −0.9 points; P≤0.001) and 12-month follow-up (mean between-group difference, −1.8 points; 95% CI, −3.1 to −0.6 points; P=0.003). Post-treatment significant differences were observed for pain, but these differences were not sustained at 12-month follow-up.”

The study authors noted that prior studies of CBT-I for pain, which had smaller samples and less rigorous control groups, have yielded mixed results. “The current study shows that CBT-I was associated with short-term reductions in pain and suggests the possibility of a small and transient reciprocal sleep-pain relationship,” they noted. “However, improvements were not sustained long-term, and further research is needed.”

McCurry and colleagues noted that limiting their study cohort to patients from KPW, as well as the fact that the majority of their cohort was White and nearly half were college educated, may limit the generalizability of their findings. Other limitations included the exclusion of patients with primary sleep disorders other than insomnia, that interventionists were not blinded to treatment assignment, and that outcomes were based on patient self-reporting.

1. Cognitive behavioral therapy for insomnia (CBT-I) delivered over the telephone bested an education-only approach for improving sleep, reducing fatigue, and alleviating pain among older adults with comorbid osteoarthritis (OA) and insomnia, researchers found.

2. Study authors noted that the CBT-I protocol is “readily scalable and provides a template for accessible, individualized, and effective treatment for chronic insomnia comorbid with OA in older adult populations,” which may improve access to CBT in medically underserved areas.

John McKenna, Associate Editor, BreakingMED™

Cat ID: 146

Topic ID: 87,146,282,408,494,730,255,50,146,397,423,68,925