Efficacy of digital cognitive behavior therapy for insomnia for the prevention of perinatal depression

数字认知行为疗法治疗失眠预防围产期抑郁症的疗效

• 批准号: 10656415
• 负责人: Jennifer Nicole Felder
• 金额: $ 74万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-07-01 至 2027-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10656415
• 关键词: Address; Arousal; Belief; Blinded; Child; Child Rearing; Childbirth; Clinical Trials Design; Cognitive; Cognitive Therapy; Complication; Data; Education; Educational Intervention; Enrollment; Family; Frequencies; Health Expenditures; Impairment; Incidence; Intervention; Knowledge; Major Depressive Disorder; Mediating; Mediator; Medicaid services; Mental Depression; Mothers; Outcome; Participant; Perinatal; Population; Postpartum Depression; Postpartum Period; Pregnancy; Pregnant Women; Prevention; Public Health; Randomized; Randomized, Controlled Trials; Recording of previous events; Research; Research Personnel; Risk Factors; Schedule; Severities; Sleep; Sleeplessness; Societies; Symptoms; Testing; Therapeutic; Therapeutic Intervention; Thinking; Training; Travel; Wait Time; Woman; animation; antepartum depression; clinically relevant; comparison group; confirmatory trial; depression prevention; depressive symptoms; design; digital; efficacy evaluation; efficacy testing; emotion regulation; experience; flexibility; follow-up; improved; interest; perinatal depressive symptom; perinatal period; peripartum depression; preference; prenatal; prenatal experience; prevent; preventive intervention; primary outcome; productivity loss; programs; sleep health; social stigma; societal costs; standard care; suicidal risk; symptomatic improvement; web site; welfare

PROJECT SUMMARY/ABSTRACT Approximately 1 in 7 women experience perinatal depression (i.e., during pregnancy or the postpartum period), making it the most common complication of childbirth. Perinatal depression is associated with long-lasting consequences, including increased risk of suicide, impairments in parenting, and immense societal costs. Prenatal insomnia is a robust risk factor for perinatal depression: nearly 1 in 4 women who experience prenatal insomnia develop postpartum depression. To date, depression prevention interventions mainly focus on pregnant women with elevated depressive symptoms or a history of depression, and no trials have investigated whether treating prenatal insomnia prevents perinatal depression. Digital cognitive behavior therapy (CBT-I) is safe and effective for treating prenatal insomnia and shows promise for preventing perinatal depression relative to standard care. Further, digital CBT-I may be of particular interest for pregnant women because it minimizes wait time, avoids burdensome traveling and scheduling requirements, and meets their preferences for flexible delivery options. The proposed project is a blinded randomized controlled trial to evaluate the efficacy of digital CBT-I for the prevention of depression during pregnancy and through 12 months postpartum among 498 non-depressed women with insomnia disorder relative to a credible, clinically-relevant control condition. Consistent with other research, sleep hygiene education will be the control condition, and will match digital CBT-I in delivery format (digital), frequency (weekly), and number of sessions (six). The proposed confirmatory efficacy trial addresses three specific aims: 1) To evaluate the efficacy of digital CBT-I for preventing perinatal depression; 2) To test whether the effect of digital CBT-I on perinatal depression is mediated through prenatal insomnia symptom improvement; 3) To test whether the effect of digital CBT-I on perinatal depression is moderated by baseline depressive symptom severity. By focusing on a low stigma target (i.e., prenatal insomnia) and using a scalable intervention, this approach has the potential to facilitate broad dissemination. The proposed project has high public health significance for reducing the burden of perinatal depression for mothers, families, and society.

项目总结/摘要 大约七分之一的妇女经历围产期抑郁症（即，在怀孕期间或产后期间）， 使其成为最常见的分娩并发症。围产期抑郁症与长期 这些后果包括自杀风险增加、养育子女的障碍以及巨大的社会成本。 产前失眠是围产期抑郁症的一个强大的危险因素：近四分之一的妇女经历产前失眠 失眠症发展为产后抑郁症。到目前为止，抑郁症预防干预措施主要集中在 有抑郁症状或抑郁症史的孕妇，没有试验调查 治疗产前失眠是否能预防围产期抑郁症。数字认知行为疗法（CBT-I） 安全有效的治疗产前失眠，并显示出预防围生期抑郁症的希望 相对于标准护理。此外，数字CBT-I可能对孕妇特别感兴趣，因为它 最大限度地减少等待时间，避免繁重的旅行和调度要求，并满足他们的喜好 灵活的交付选项。拟开展的项目为盲法随机对照试验， 数字CBT-I预防怀孕期间和产后12个月抑郁症的功效 在498名患有失眠症的非抑郁女性中， 条件与其他研究一致，睡眠卫生教育将是控制条件， 数字化CBT-I的交付格式（数字）、频率（每周）和会话次数（六次）。拟议 验证性疗效试验解决了三个具体目标：1）评估数字CBT-I对 探讨数字化CBT-I对围生期抑郁症的影响， 通过产前失眠症状的改善介导; 3）为了测试数字CBT-I是否对 围生期抑郁症受基线抑郁症状严重程度的影响。通过关注低耻辱感 目标（即，产前失眠），并使用可扩展的干预，这种方法有可能促进 广泛传播。该项目对减轻农民负担具有重要的公共卫生意义。 围产期抑郁症对母亲、家庭和社会的影响。