Effect of Telephone Cognitive Behavioral Therapy for Insomnia in Older Adults With Osteoarthritis Pain: A Randomized Clinical Trial

Abstract

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 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 < .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, ≤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 = <.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 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.

Conflict of interest statement

Conflict of Interest Disclosures: Dr McCurry reported receiving grants from the National Institute on Aging (NIA) during the conduct of the study. Dr Zhu reported receiving grants from NIA during the conduct of the study. Dr Von Korff reported receiving grants from NIA during the conduct of the study and served as principal investigator of grants to Group Health Research Institute, now Kaiser Permanente Washington Health Research Institute, from Pfizer and the Campbell Alliance Group. Dr Wellman reported receiving grants from NIA during the conduct of the study. Dr Morin reported receiving grants from Idorsia and Canopy Health; personal fees for consulting and serving on advisory boards from Eisai, Merck, Pear Therapeutics, Sunovion, and Weight Watchers outside of the submitted work; and royalties from Mapi Research Trust. Dr Yeung reported grants from NIA during the conduct of the study. No other disclosures were reported.

Figures

Figure 1.. CONSORT Diagram

CBT-I indicates cognitive behavioral therapy for insomnia; EOC, education-only control. aOne participant in the EOC group did not provide 2-month posttreatment data but did provide 12-month follow-up data.

Figure 2.. Insomnia Severity Index Remission Over Time

Scores in the range of no insomnia (0-7 points) are shown. CBT-I indicates cognitive behavioral therapy for insomnia; EOC, education-only control.