Abstract：
OBJECTIVE: Evaluate a triaged stepped-care strategy among adults 50 and older with insomnia disorder.
METHODS: Participants (N=245) were classified at baseline by a Triage-Checklist. Those projected to do better if they start treatment with therapist versus digitally delivered CBT-I (tCBT-I versus dCBT-I) constituted the YES stratum (n=137); the rest constituted the NO stratum (n=108). Participants were randomized within stratum to a strategy that utilized only dCBT-I (ONLN) or to a strategy that prospectively allocated the first step of care to dCBT-I or tCBT-I based on the Triage-Checklist and switched dCBT-I non-responders at 2-months to tCBT-I (STEP). Co-primary outcomes were the insomnia severity index (ISI) and the average nightly amount of prescription hypnotic medications used (MEDS), assessed at 2,4,6,9, and 12 months post-randomization.
RESULTS: Mixed effects models revealed that, compared to ONLN, participants in STEP had greater reductions in ISI (p=0.001; η2=0.01) and MEDS (p=0.019, η2=0.01). Within the YES stratum, compared to ONLN, those in STEP had greater reductions in ISI (p=0.0001, η2=0.023) and MEDS (p=0.018, η2=0.01). Within the ONLN arm, compared to the YES stratum, those in the NO stratum had greater reductions in ISI (p=0.015, η2=0.01) but not in MEDS. Results did not change with treatment-dose covariate adjustment.
CONCLUSIONS: Triaged-stepped care can help guide allocation of limited CBT-I treatment resources to promote effective and safe treatment of chronic insomnia among middle age and older adults. Further refinement of the Triage-Checklist and optimization of the timing and switching criteria may improve the balance between effectiveness and use of resources.
METHODS: Participants (N=245) were classified at baseline by a Triage-Checklist. Those projected to do better if they start treatment with therapist versus digitally delivered CBT-I (tCBT-I versus dCBT-I) constituted the YES stratum (n=137); the rest constituted the NO stratum (n=108). Participants were randomized within stratum to a strategy that utilized only dCBT-I (ONLN) or to a strategy that prospectively allocated the first step of care to dCBT-I or tCBT-I based on the Triage-Checklist and switched dCBT-I non-responders at 2-months to tCBT-I (STEP). Co-primary outcomes were the insomnia severity index (ISI) and the average nightly amount of prescription hypnotic medications used (MEDS), assessed at 2,4,6,9, and 12 months post-randomization.
RESULTS: Mixed effects models revealed that, compared to ONLN, participants in STEP had greater reductions in ISI (p=0.001; η2=0.01) and MEDS (p=0.019, η2=0.01). Within the YES stratum, compared to ONLN, those in STEP had greater reductions in ISI (p=0.0001, η2=0.023) and MEDS (p=0.018, η2=0.01). Within the ONLN arm, compared to the YES stratum, those in the NO stratum had greater reductions in ISI (p=0.015, η2=0.01) but not in MEDS. Results did not change with treatment-dose covariate adjustment.
CONCLUSIONS: Triaged-stepped care can help guide allocation of limited CBT-I treatment resources to promote effective and safe treatment of chronic insomnia among middle age and older adults. Further refinement of the Triage-Checklist and optimization of the timing and switching criteria may improve the balance between effectiveness and use of resources.
摘要：
目的：评估50岁及以上失眠症患者的分级分级护理策略。
方法：参与者（N=245）在基线时通过分诊清单进行分类。如果他们开始接受治疗师治疗而不是数字交付的CBT-I（tCBT-I与dCBT-I），则预计会做得更好的人构成YES层（n=137）；其余的构成NO层（n=108）。参与者在阶层中被随机分配到仅使用dCBT-I（ONLN）的策略，或根据分类清单前瞻性地将护理的第一步分配给dCBT-I或tCBT-I的策略，并在2个月时将dCBT-I无反应者转换为tCBT-I（步骤）。共同的主要结果是失眠严重程度指数（ISI）和平均每晚使用的处方催眠药物（MEDS），在随机化后2、4、6、9和12个月进行评估。
结果：混合效应模型显示，与ONLN相比,STEP参与者的ISI(p=0.001;η2=0.01)和MEDS(p=0.019,η2=0.01)降低幅度更大.在YES地层内,与ONLN相比,STEP中的患者ISI(p=0.0001,η2=0.023)和MEDS(p=0.018,η2=0.01)的降低幅度更大.在ONLN手臂内，与YES层相比，NO层的ISI降低幅度更大（p=0.015，η2=0.01），而MEDS则没有。结果没有随着治疗剂量协变量的调整而改变。
结论：分级分级治疗有助于指导有限的CBT-I治疗资源的分配，以促进中年和老年人慢性失眠的有效和安全治疗。分类清单的进一步完善以及定时和切换标准的优化可以改善资源的有效性和使用之间的平衡。
方法：参与者（N=245）在基线时通过分诊清单进行分类。如果他们开始接受治疗师治疗而不是数字交付的CBT-I（tCBT-I与dCBT-I），则预计会做得更好的人构成YES层（n=137）；其余的构成NO层（n=108）。参与者在阶层中被随机分配到仅使用dCBT-I（ONLN）的策略，或根据分类清单前瞻性地将护理的第一步分配给dCBT-I或tCBT-I的策略，并在2个月时将dCBT-I无反应者转换为tCBT-I（步骤）。共同的主要结果是失眠严重程度指数（ISI）和平均每晚使用的处方催眠药物（MEDS），在随机化后2、4、6、9和12个月进行评估。
结果：混合效应模型显示，与ONLN相比,STEP参与者的ISI(p=0.001;η2=0.01)和MEDS(p=0.019,η2=0.01)降低幅度更大.在YES地层内,与ONLN相比,STEP中的患者ISI(p=0.0001,η2=0.023)和MEDS(p=0.018,η2=0.01)的降低幅度更大.在ONLN手臂内，与YES层相比，NO层的ISI降低幅度更大（p=0.015，η2=0.01），而MEDS则没有。结果没有随着治疗剂量协变量的调整而改变。
结论：分级分级治疗有助于指导有限的CBT-I治疗资源的分配，以促进中年和老年人慢性失眠的有效和安全治疗。分类清单的进一步完善以及定时和切换标准的优化可以改善资源的有效性和使用之间的平衡。
