Cousins Center for Psychoneuroimmunology, Jane and Terry Semel Institute for Neuroscience and Human Behavior, David Geffen School of Medicine at UCLA (University of California, Los Angeles).
Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA.
JAMA Psychiatry. 2022 Jan 1;79(1):33-41. doi: 10.1001/jamapsychiatry.2021.3422.
Older adults with insomnia have a high risk of incident and recurrent depression. Depression prevention is urgently needed, and such efforts have been neglected for older adults.
To examine whether treatment of insomnia disorder with cognitive behavioral therapy for insomnia (CBT-I) compared with an active comparator condition, sleep education therapy (SET), prevents major depressive disorder in older adults.
DESIGN, SETTING, AND PARTICIPANTS: This assessor-blinded, parallel-group, single-site randomized clinical trial assessed a community-based sample of 431 people and enrolled 291 adults 60 years or older with insomnia disorder who had no major depression or major health events in past year. Study recruitment was performed from July 1, 2012, to April 30, 2015. The trial protocol was modified to extend follow-up from 24 to 36 months, with follow-up completion in July 2018. Data analysis was performed from March 1, 2019, to March 30, 2020.
Participants were randomized to 2 months of CBT-I (n = 156) or SET (n = 135).
The primary outcome was time to incident major depressive disorder as diagnosed by interview and Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) criteria. Secondary outcome was sustained remission of insomnia disorder before depression event or duration of follow-up.
Among 291 randomized participants (mean [SD] age, 70.1 [6.7] years; 168 [57.7%] female; 7 [2.4%] Asian, 32 [11.0%] Black, 3 [1.0%] Pacific Islander, 241 [82.8%] White, 6 [2.1%] multiracial, and 2 [0.7%] unknown), 156 were randomized to CBT-I and 135 to SET. A total of 140 participants (89.7%) completed CBT-I and 130 (96.3%) participants completed SET (χ2 = 4.9, P = .03), with 114 (73.1%) completing 24 months of follow-up in the CBT-I group and 117 (86.7%) in the SET group (χ2 = 8.4, P = .004). After protocol modification, 92 (59.0%) of the CBT-I participants and 86 (63.7%) of the SET participants agreed to extended follow-up (χ2 = 0.7, P = .41), with 81 (51.9%) of the CBT-I participants and 77 (57.0%) of the SET group completing 36 months of follow-up (χ2 = 0.8; P = .39). Incident or recurrent major depression occurred in 19 participants (12.2%) in the CBT-I group and in 35 participants (25.9%) in the SET group, with an overall benefit (hazard ratio, 0.51; 95%, CI 0.29-0.88; P = .02) consistent across subgroups. Remission of insomnia disorder continuously sustained before depression event or during follow-up was more likely in CBT-I participants (41 [26.3%]) compared with the SET participants (26 [19.3%], P = .03). Those in the CBT-I group with sustained remission of insomnia disorder had an 82.6% decreased likelihood of depression (hazard ratio, 0.17; 95%, CI 0.04-0.73; P = .02) compared with those in the SET group without sustained remission of insomnia disorder.
The findings of this randomized clinical trial indicate that treatment of insomnia with CBT-I has an overall benefit in the prevention of incident and recurrent major depression in older adults with insomnia disorder. Community-level screening for insomnia concerns in older adults and wide delivery of CBT-I-based treatment for insomnia could substantially advance public health efforts to treat insomnia and prevent depression in this vulnerable older adult population.
ClinicalTrials.gov Identifier: NCT01641263.
患有失眠症的老年人有发生和复发性抑郁的高风险。迫切需要预防抑郁症，而老年人的这种需求却被忽视了。
研究认知行为疗法治疗失眠（CBT-I）与主动对照组，睡眠教育疗法（SET）相比，是否可以预防老年人的重度抑郁症。
设计、地点和参与者：这是一项评估者盲法、平行组、单站点随机临床试验，评估了一个基于社区的样本，共有 431 人，其中 291 名年龄在 60 岁及以上、过去一年中没有重度抑郁症或重大健康事件的失眠障碍成年人。研究招募于 2012 年 7 月 1 日至 2015 年 4 月 30 日进行。试验方案修改为将随访时间从 24 个月延长至 36 个月，随访于 2018 年 7 月完成。数据分析于 2019 年 3 月 1 日至 3 月 30 日进行。
参与者被随机分配到 2 个月的 CBT-I（n=156）或 SET（n=135）治疗组。
主要结局是通过访谈和《精神障碍诊断与统计手册》（第五版）标准诊断为新发重度抑郁症的时间。次要结局是在抑郁事件发生前或随访期间持续缓解失眠症。
在 291 名随机参与者中（平均[标准差]年龄 70.1[6.7]岁；168[57.7%]为女性；7[2.4%]为亚洲人，32[11.0%]为黑人，3[1.0%]为太平洋岛民，241[82.8%]为白人，6[2.1%]为多种族，2[0.7%]为未知种族），156 名参与者被随机分配到 CBT-I 组，135 名参与者被随机分配到 SET 组。共有 140 名参与者（89.7%）完成了 CBT-I 治疗，130 名（96.3%）参与者完成了 SET 治疗（χ2=4.9，P=0.03），其中 114 名（73.1%）完成了 24 个月的随访，117 名（86.7%）完成了 SET 组的随访（χ2=8.4，P=0.004）。在方案修改后，92 名（59.0%）的 CBT-I 参与者和 86 名（63.7%）的 SET 参与者同意延长随访（χ2=0.7，P=0.41），其中 81 名（51.9%）的 CBT-I 参与者和 77 名（57.0%）的 SET 组完成了 36 个月的随访（χ2=0.8；P=0.39）。在 CBT-I 组中，19 名（12.2%）参与者发生了新发或复发性重度抑郁症，SET 组中有 35 名（25.9%）参与者发生了重度抑郁症，两组之间的总体益处（风险比，0.51；95%置信区间，0.29-0.88；P=0.02）一致。与 SET 组相比，CBT-I 组在抑郁事件发生前或随访期间持续缓解失眠症的可能性更大（41[26.3%]vs 26[19.3%]，P=0.03）。与 SET 组相比，持续缓解失眠症的 CBT-I 组发生抑郁症的可能性降低了 82.6%（风险比，0.17；95%置信区间，0.04-0.73；P=0.02）。
这项随机临床试验的结果表明，在患有失眠症的老年人中，用 CBT-I 治疗失眠症可以整体预防新发和复发性重度抑郁症。在老年人中进行社区层面的失眠症筛查，并广泛提供基于 CBT-I 的失眠症治疗，可以极大地推进公共卫生工作，以治疗这一脆弱的老年人群的失眠症并预防抑郁症。
ClinicalTrials.gov 标识符：NCT01641263。
