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 versus 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 MEASURES: The 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). RESULTS: Of 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 < 0.001). 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 posttreatment (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). Posttreatment significant differences were observed for pain, but these differences were not sustained at 12-month follow-up. CONCLUSIONS AND RELEVANCE: In 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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