0469 Perceptions of an Education Only Control Group in the Osteoarthritis and Therapy for Sleep (OATS) Study: An Ongoing Statewide, Telephone-Delivered CBT for Insomnia (CBT-I) Randomized Trial

Abstract

Abstract Introduction Comorbid osteoarthritis (OA) and insomnia is common in older adults. CBT-I is efficacious for improving sleep in older persons with OA but not widely accessible. We examined treatment process data from OATS, a large ongoing clinical trial of telephone-delivered CBT-I. Methods 327 Kaiser Permanente Washington members aged 60+ with OA, Insomnia Severity Index scores of 11+, and Brief Pain Inventory scores of 9+ were randomized to individual CBT-I vs. education only control (EOC). Six telephone sessions of CBT-I or EOC were offered over eight weeks. Participants rated their perceptions of treatment (credibility, acceptability, suitability, perceived effectiveness, adherence, and therapeutic relationship) on a 7-point Likert scale after session 1 and at 2-month post-test. Results Participants (mean age=70.2 years, 74.6% female) were randomized to the two treatment arms (CBT-I=163, EOC=164). Participants did not differ significantly across arms by age, gender, education, or by sleep, pain, or mood (depression, fatigue) outcome measures at baseline. CBT-I had significantly (p=.03) more white participants (90% CBT-I, 78% EOC). Study retention was 82% and 88% at post-test for CBT-I versus EOC, respectively. There was no difference in number of sessions attended (median=6). CBT-I sessions were somewhat longer than EOC (24.2 vs. 22.8 minutes; p=.005). Most participants in both groups at both time points gave high rankings (5+/7 points) on all six treatment perception ratings (CBT-I range: 75.9-99.3%; EOC range: 69.0-97.9%). Average summed treatment perception ratings improved between Session 1 and post-test for both conditions (mean=5.9 and 6.1, respectively, for CBT-I; mean=5.6 and 5.8, respectively, for EOC). Conclusion The OATS EOC group was credible and acceptable to participants, resulting in equivalently high levels of participation and retention compared to CBT-I. Findings suggest the ongoing trial has adequately controlled for nonspecific participant treatment effects that might confound interpretation of efficacy outcomes. Support This work was supported by PHS grant 5R01AG053221.