Stepped-Care Management of Insomnia: Treatment Choices Guided by a Patient Decision Aid in a Pragmatic Nonrandomized Clinical Trial Setting.

Patients with insomnia face difficult decisions when choosing between treatment options with competing risk-benefit profiles. Patient treatment choices were evaluated as part of a pragmatic nonrandomized clinical trial for a two-step cognitive behavioural therapy for insomnia (CBT-I) intervention. Upon enrollment, participants were guided by a patient decision aid (PtDA), outlining the risk-benefit profiles of medication, face-to-face CBT-I (FtFCBT-I), and digital CBT-I (dCBT-I). In Step 1, participants chose between dCBT-I alone, combined dCBT-I plus medication or medication alone. Non-remitters who enrolled into Step 2 chose between FtFCBT-I, medication, or no additional treatment. A secondary analysis was conducted evaluating patient treatment choices, the presence of decisional conflict, and the acceptability of the PtDA. In Step 1, 47.4% (n = 73) of participants chose dCBT-I, followed by combined dCBT-I plus medication (42.3% n = 66) and medication alone (9.74%; n = 15). The dCBT-I group was less likely to use medications or used them less frequently compared to the other treatment groups. Men and individuals less motivated to change sleep habits were more likely to choose medication in Step 1. In Step 2, 60.9% (n = 42) of non-remitters chose FtFCBT-I, followed by no additional treatment (23.6%; n = 16) and medication (15.9%; n = 11). Non-remitters from the medication group in Step 1 were more likely to choose medication again in Step 2. Over 90% of participants across both treatment steps endorsed the PtDA as acceptable and facilitated their decision-making. This corroborated with the minimal decisional conflict observed, highlighting a potential role in further developing and integrating patient decision aids into practice. Trial Registration: NCT03633305.