Manber Rachel, Gumport Nicole B, Tully Isabelle A, Kim Jane P, Kim Bohye, Simpson Norah, Rosas Lisa G, Zulman Donna M, Goldhaber-Fiebert Jeremy D, Rangel Elizabeth, Dietch Jessica R, Tutek Joshua, Palaniappan Latha
Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA.
Department of Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA, USA.
Sleep. 2025 Jan 13;48(1). doi: 10.1093/sleep/zsae182.
Evaluate a triaged stepped-care strategy among adults 50 and older with insomnia disorder.
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 vs 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 nonresponders 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 postrandomization.
Mixed effects models revealed that, compared to ONLN, participants in STEP had greater reductions in ISI (p = .001; η2 = 0.01) and MEDS (p = .019, η2 = 0.01). Within the YES stratum, compared to ONLN, those in STEP had greater reductions in ISI (p = .0001, η2 = 0.023) and MEDS (p = .018, η2 = 0.01). Within the ONLN arm, compared to the YES stratum, those in the NO stratum had greater reductions in ISI (p = .015, η2 = 0.01) but not in MEDS. Results did not change with treatment-dose covariate adjustment.
Triaged-stepped care can help guide the allocation of limited CBT-I treatment resources to promote effective and safe treatment of chronic insomnia among middle-aged 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.
Name: The RESTING Insomnia Study: Randomized Controlled Study on Effectiveness of Stepped-Care Sleep Therapy.
NCT03532282. URL: https://clinicaltrials.gov/study/NCT03532282.
评估针对50岁及以上患有失眠症的成年人的分诊逐步护理策略。
参与者（N = 245）在基线时通过分诊清单进行分类。那些预计如果开始接受治疗师治疗而非数字化交付的失眠认知行为疗法（tCBT - I与dCBT - I）效果会更好的人构成“是”组（n = 137）；其余的构成“否”组（n = 108）。参与者在组内被随机分配到仅使用dCBT - I的策略（ONLN）或根据分诊清单将护理的第一步前瞻性地分配给dCBT - I或tCBT - I并在2个月时将无反应的dCBT - I使用者转为tCBT - I的策略（STEP）。共同主要结局是失眠严重程度指数（ISI）和随机分组后2、4、6、9和12个月使用的处方催眠药物的平均每晚用量（MEDS）。
混合效应模型显示，与ONLN相比，STEP组的参与者在ISI（p = 0.001；η2 = 0.01）和MEDS（p = 0.019，η2 = 0.01）方面有更大程度的降低。在“是”组内，与ONLN相比，STEP组的参与者在ISI（p = 0.0001，η2 = 0.023）和MEDS（p = 0.018，η2 = 0.01）方面有更大程度的降低。在ONLN组中，与“是”组相比，“否”组的参与者在ISI方面有更大程度的降低（p = 0.015，η2 = 0.01），但在MEDS方面没有。治疗剂量协变量调整后结果未改变。
分诊逐步护理有助于指导有限的失眠认知行为疗法治疗资源的分配，以促进中年及老年人慢性失眠的有效和安全治疗。进一步完善分诊清单以及优化时间安排和转换标准可能会改善有效性与资源利用之间的平衡。
名称：RESTING失眠研究：逐步护理睡眠疗法有效性的随机对照研究。
NCT03532282。网址：https://clinicaltrials.gov/study/NCT03532282。
