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

TitleEfficacy of a stepped care approach to deliver cognitive-behavioral therapy for insomnia in cancer patients: a noninferiority randomized controlled trial.
Publication TypeJournal Article
Year of Publication2021
AuthorsSavard, J, Ivers, H, Savard, M-H, Morin, CM, Caplette-Gingras, A, Bouchard, S, Lacroix, G
JournalSleep
Volume44
Issue11
Date Published2021 11 12
ISSN1550-9109
KeywordsAnxiety, Cognitive Behavioral Therapy, Fatigue, Humans, Neoplasms, Sleep Initiation and Maintenance Disorders, Treatment Outcome
Abstract

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 noninferiority 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 more severe insomnia received 6 face-to-face CBT-I sessions (n = 53). In both cases, patients could receive up to three 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 was 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.TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01864720 (https://clinicaltrials.gov/ct2/show/NCT01864720?term=Savard&draw=2&rank=6; Stepped Care Model for the Wider Dissemination of Cognitive-Behavioural Therapy for Insomnia Among Cancer Patients).

DOI10.1093/sleep/zsab166
Alternate JournalSleep
PubMed ID34228123
PubMed Central IDPMC8598200
Grant List#125968 / / CIHR / Canada