TY - JOUR AU - C. M. Morin AU - S. J. Chen AU - K. Lemieux AU - H. Ivers AU - J. M. Y. Cheung AU - M. Lamy AU - L. Ritterband A1 - AB - OBJECTIVE: To evaluate the effectiveness of a stepped-care intervention for insomnia in primary care. METHODS: In this non-randomized pragmatic clinical trial, patients from primary care clinics and with chronic insomnia disorder were allowed to choose between continuing their usual treatment (prescribed sleep medication) or receiving digital CBT-I (dCBT-I), either alone or in combination with medication. After the first treatment step, non-remitters were provided with the choice of receiving face-to-face CBT-I (FtFCBT-I), medication, or no additional treatment. The primary outcome was insomnia symptoms as measured by the Insomnia Severity Index. RESULTS: Among 154 adults with insomnia, 73 were allocated to dCBT-I, 66 to combined treatment and 15 to medication alone based on their preference. When compared to medication alone, first-step treatment with dCBT-I or combined treatment both produced significantly larger effects on reducing insomnia severity (dCBT-I vs Med, difference in the mean changes = -3.3; Comb vs Med, -3.7), and led to higher percentages of responders (dCBT-I vs Med, 54.8 % vs 16.0 %, OR = 6.38; Comb vs Med, 53.6 % vs 16.0 %, OR = 6.07) and remitters (dCBT-I vs Med, 65.8 % vs 9.4 %, OR = 18.61; Comb vs Med, 67.5 % vs 9.4 %, OR = 20.13). Adding FtFCBT-I as second-step treatment offered an added value for non-remitters after the first-step treatment. Improvements achieved at post-treatment were sustained through the 6-month follow-up for most of the treatment sequences. CONCLUSIONS: These findings demonstrated the feasibility and efficiency of implementing digital and in-person CBT-I within a stepped-care model in primary care practice. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03633305. AD - École de psychologie, Université Laval, 2325 rue des Bibliothèques, Québec, Québec, G1V 0A6, Canada; Centre de recherche CERVO/Brain Research Center, 2301 Av. D'Estimauville, Québec, Québec, G1E 1T2, Canada. Electronic address: cmorin@psy.ulaval.ca.; École de psychologie, Université Laval, 2325 rue des Bibliothèques, Québec, Québec, G1V 0A6, Canada; Centre de recherche CERVO/Brain Research Center, 2301 Av. D'Estimauville, Québec, Québec, G1E 1T2, Canada; Li Chiu Kong Family Sleep Assessment Unit, Department of Psychiatry, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong Special Administrative Region of China.; Université Laval, Faculté de médecine; Centre de santé et services sociaux de Chaudière-Appalaches, Groupe de médecine familiale de Lévis, 100-1205 Boulevard Guillaume-Couture, Lévis, Québec, G6W 0J4, Canada.; École de psychologie, Université Laval, 2325 rue des Bibliothèques, Québec, Québec, G1V 0A6, Canada; Centre de recherche CERVO/Brain Research Center, 2301 Av. D'Estimauville, Québec, Québec, G1E 1T2, Canada.; École de psychologie, Université Laval, 2325 rue des Bibliothèques, Québec, Québec, G1V 0A6, Canada; Centre de recherche CERVO/Brain Research Center, 2301 Av. D'Estimauville, Québec, Québec, G1E 1T2, Canada; School of Pharmacy, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.; Center for Behavioral Health and Technology, University of Virginia, PO Box 801075, Charlottesville, VA, 22908, USA. AN - 40373353 BT - Sleep Med C5 - HIT & Telehealth DA - Aug DO - 10.1016/j.sleep.2025.106551 DP - NLM ET - 20250503 JF - Sleep Med LA - eng N2 - OBJECTIVE: To evaluate the effectiveness of a stepped-care intervention for insomnia in primary care. METHODS: In this non-randomized pragmatic clinical trial, patients from primary care clinics and with chronic insomnia disorder were allowed to choose between continuing their usual treatment (prescribed sleep medication) or receiving digital CBT-I (dCBT-I), either alone or in combination with medication. After the first treatment step, non-remitters were provided with the choice of receiving face-to-face CBT-I (FtFCBT-I), medication, or no additional treatment. The primary outcome was insomnia symptoms as measured by the Insomnia Severity Index. RESULTS: Among 154 adults with insomnia, 73 were allocated to dCBT-I, 66 to combined treatment and 15 to medication alone based on their preference. When compared to medication alone, first-step treatment with dCBT-I or combined treatment both produced significantly larger effects on reducing insomnia severity (dCBT-I vs Med, difference in the mean changes = -3.3; Comb vs Med, -3.7), and led to higher percentages of responders (dCBT-I vs Med, 54.8 % vs 16.0 %, OR = 6.38; Comb vs Med, 53.6 % vs 16.0 %, OR = 6.07) and remitters (dCBT-I vs Med, 65.8 % vs 9.4 %, OR = 18.61; Comb vs Med, 67.5 % vs 9.4 %, OR = 20.13). Adding FtFCBT-I as second-step treatment offered an added value for non-remitters after the first-step treatment. Improvements achieved at post-treatment were sustained through the 6-month follow-up for most of the treatment sequences. CONCLUSIONS: These findings demonstrated the feasibility and efficiency of implementing digital and in-person CBT-I within a stepped-care model in primary care practice. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03633305. PY - 2025 SN - 1389-9457 SP - 106551 ST - Stepped care for insomnia in primary care using digital and face-to-face cognitive behavioral therapies: A pragmatic nonrandomized clinical trial T1 - Stepped care for insomnia in primary care using digital and face-to-face cognitive behavioral therapies: A pragmatic nonrandomized clinical trial T2 - Sleep Med TI - Stepped care for insomnia in primary care using digital and face-to-face cognitive behavioral therapies: A pragmatic nonrandomized clinical trial U1 - HIT & Telehealth U3 - 10.1016/j.sleep.2025.106551 VL - 132 VO - 1389-9457 Y1 - 2025 ER -