IMPORTANCE Scalable delivery models of cognitive behavioral therapy for insomnia (CBT-I), an effective treatment, are needed for widespread implementation, particularly in rural and underserved populations lacking ready access to insomnia treatment. OBJECTIVE To evaluate the effectiveness of telephone CBT-I vs education-only control (EOC) in older adults with moderate to severe osteoarthritis pain.DESIGN, SETTING, AND PARTICIPANTS This is a randomized clinical trial of 327 participants 60 years and older who were recruited statewide through Kaiser Permanente Washington from September 2016 to December 2018. Participants were double screened 3 weeks apart for moderate to severe insomnia and osteoarthritis (OA) pain symptoms. Blinded assessments were conducted at baseline, after 2 months posttreatment, and at 12-month follow-up.INTERVENTIONS Six 20-to 30-minute telephone sessions provided over 8 weeks. Participants submitted daily diaries and received group-specific educational materials. The CBT-I instruction included sleep restriction, stimulus control, sleep hygiene, cognitive restructuring, and homework. The EOC group received information about sleep and OA. MAIN OUTCOMES AND MEASURESThe primary outcome was score on the Insomnia Severity Index (ISI) at 2 months posttreatment and 12-month follow-up. Secondary outcomes included pain (score on the Brief Pain Inventory-short form), depression (score on the 8-item Patient Health Questionnaire), and fatigue (score on the Flinders Fatigue Scale). RESULTSOf the 327 participants, the mean (SD) age was 70.2 (6.8) years, and 244 (74.6%) were women. In the 282 participants with follow-up ISI data, the total 2-month posttreatment 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 < .001). Results were sustained at 12-month follow-up (adjusted mean difference, −3.0 points; 95% CI, −4.1 to −2.0 points; P < .001). At 12-month follow-up, 67 of 119 (56.3%) participants receiving CBT-I remained in remission (ISI score, Յ7) 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 posttreatment (mean between-group difference, −2.0 points; 95% CI, −3.1 to −0.9 points; P = <.001) and 12-month follow-up (mean between-group difference, −1.8 points; 95% CI, −3.1 to −0.6 points; P = .003). Posttreatment significant differences were observed for pain, but these differences were not sustained at 12-month follow-up. CONCLUSIONS AND RELEVANCEIn this randomized clinical trial, telephone CBT-I was effective in improving sleep, fatigue, and, to a lesser degree, pain among older adults with comorbid insomnia and OA pain in a large statewide health plan. Results support provision of telephone CBT-I as an accessible, individualized, effective, and scalable insomnia treatment.TRIAL REGISTRATION Clinical Trials.gov Identifier: NCT02946957

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Cognitive behavioral therapy for insomnia (CBT-I) is the preferred treatment for chronic insomnia and sleep-related cognitions are one target of treatment. There has been little systematic investigation of how sleep-related cognitions are being assessed in CBT-I trials and no metaanalysis of the impact of CBT-I on dysfunctional beliefs about sleep, a core cognitive component of treatment. Academic Search Complete, Medline, CINAHL and PsychInfo from 1990-2018 were searched to identify randomized controlled trials of CBT-I in adults (≥18 years) reporting some measure of sleep-related cognitions. Sixteen randomized controlled trials were identified comparing 1134 CBT-I and 830 control subjects. The Dysfunctional Beliefs and Attitudes about Sleep Scale was utilized almost exclusively to assess sleep-related cognitions in these trials. Hedge's g at 95% confidence interval (CI) was calculated to assess CBT-I effect size at posttreatment compared to controls. CBT-I significantly reduced dysfunctional beliefs about sleep (g = −0.90, 95% CI −1.19, −0.62) at post-treatment Three trials contributed data to estimate effect size for long-term effects (g= −1.04 (95% CI −2.07, −0.02) with follow up time ranging from 3 -18 months. We concluded that cognitive behavioral therapy for insomnia has moderate to large effects on dysfunctional beliefs about sleep.