Efficacy of a stepped care approach to deliver cognitive-behavioral therapy for insomnia in cancer patients: A non-inferiority randomized controlled trial.

STUDY OBJECTIVES Cognitive-behavioral therapy for insomnia (CBT-I) is the recommended first-line treatment for cancer-related insomnia, but its accessibility is very limited in routine care. A stepped care approach has been recommended as a cost-effective way to make CBT-I more widely accessible. However, no controlled study has yet been published about the efficacy of this approach. The goal of this non-inferiority randomized controlled trial (RCT) was to compare the short and long-term efficacy of a stepped care CBT-I (StepCBT-I) to a standard face-to-face CBT-I (StanCBT-I). METHODS A total of 177 cancer patients were randomized to: 1) StanCBT-I (6 face-to-face CBT-I sessions; n=59); or 2) StepCBT-I (n=118). In the StepCBT-I group, patients with less severe insomnia first received a web-based CBT-I (n=65), while those with a more severe insomnia received 6 face-to-face CBT-I sessions (n=53). In both cases, patients could receive up to 3 booster sessions of CBT-I if they still had insomnia symptoms following this first step. RESULTS Results indicated that the Step-CBT-I group showed an Insomnia Severity Index score reduction and a sleep efficiency (on a sleep diary) increase that were not significantly inferior to that of StanCBT-I at all post-treatment time points. Analyses of secondary outcomes indicated significant time effects (ps<.001) and no significant group-by-time interactions (ps from .07 to .91) on other sleep diary parameters, sleep medication use, depression, anxiety, fatigue and quality of life scores. CONCLUSION(S) The efficacy of stepped care CBT-I is not inferior to that of a standard face-to-face intervention and is a valuable approach to making this treatment more widely accessible to cancer patients.