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

数字认知行为疗法治疗失眠预防围产期抑郁症的疗效 - 补充

• 批准号: 10794868
• 负责人: Jennifer Nicole Felder
• 金额: $ 8.08万
• 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 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10794868
• 关键词: Address; Arousal; Award; 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; Parents; 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 FROM PARENT AWARD 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.

项目摘要/来自上级奖项的摘要 大约每7名妇女中就有1人患有围产期抑郁症(即在怀孕期间或产后)， 使其成为分娩最常见的并发症。围产期抑郁与持续时间长有关 后果，包括自杀风险增加、育儿障碍和巨大的社会成本。 产前失眠是围产期抑郁的重要危险因素：近1/4经历过产前抑郁的女性 失眠会导致产后抑郁症。到目前为止，抑郁症预防干预主要集中在 抑郁症状升高或有抑郁史的孕妇，没有试验研究 治疗产前失眠能否预防围产期抑郁。数字认知行为疗法(CBT-I)是 治疗产前失眠安全有效，有望预防围产期抑郁 相对于标准护理。此外，孕妇可能对数字CBT-I特别感兴趣，因为它 最大限度地减少等待时间，避免繁重的旅行和日程安排要求，并满足他们的偏好 提供灵活的交付选项。建议的项目是一项盲法随机对照试验，以评估 数字化CBT-I预防孕期及产后12个月抑郁的效果 在498名患有失眠障碍的非抑郁女性中，与可信的、临床相关的对照相比 条件。与其他研究一致，睡眠卫生教育将是控制条件，并将匹配 数字CBT-I，提供格式(数字)、频率(每周)和会议次数(六次)。建议数 验证性疗效试验涉及三个具体目标：1)评估数字CBT-I对 2)检验数字CBT-I对围产期抑郁的影响 通过产前失眠症状的改善来调节；3)测试数字CBT-I对胎儿失眠症状的影响 围产期抑郁受基线抑郁症状严重程度的影响。通过专注于低耻辱 目标(即产前失眠)，并使用可扩展的干预措施，这种方法有可能促进 广泛传播。建议的项目对减轻农村居民的负担具有很高的公共卫生意义。 母亲、家庭和社会的围产期抑郁。