CBT-Insomnia Augmenting Usual Care SSRIs to Improve Youth Depression Outcomes

CBT-失眠增强日常护理 SSRIs 可改善青少年抑郁症的结果

• 批准号: 8767713
• 负责人: GREGORY N CLARKE
• 金额: $ 78.3万
• 依托单位: KAISER FOUNDATION RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-05 至 2018-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8767713
• 关键词: Acute; Address; Adolescence; Adolescent; Adult; Adverse effects; Affect; Affective; Age; Antidepressive Agents; Anxiety; Arousal; Behavior; Child; Chronic; Clinical effectiveness; Cognitive; Comorbid Insomnia; Comorbidity; Comprehensive Health Care; Computerized Medical Record; Coping Skills; Data; Depressed mood; Development; Diagnostic; Direct Costs; Disease remission; Economics; Education; Effectiveness; Emotional; Emotions; Facilities and Administrative Costs; Functional disorder; Funding; Gender; Goals; Healthcare; Hygiene; Individual Differences; Intervention; Life; Major Depressive Disorder; Manuals; Mediation; Mental Depression; Mental Health; National Institute of Mental Health; Nature; Outcome; Parents; Participant; Patients; Pattern; Performance; Pharmaceutical Preparations; Pharmacological Treatment; Pilot Projects; Procedures; Process; Protocols documentation; Qualifying; Randomized; Recovery; Regulation; Reporting; Research; Research Domain Criteria; Rest; Risk; Route; Science; Selective Serotonin Reuptake Inhibitor; Severities; Sleep; Sleep Disorders; Sleeplessness; System; Telephone; Testing; Time; United States National Institutes of Health; Variant; Work; Youth; actigraphy; base; behavior change; child depression; cost; cost effective; cost effectiveness; depressive symptoms; dissemination research; efficacy testing; experience; health care service utilization; health related quality of life; implementation research; improved; indexing; intervention effect; novel; physical conditioning; psychologic; public health relevance; recurrent depression; response; secondary outcome; social; success; symposium; treatment as usual

DESCRIPTION (provided by applicant): Psychological and pharmacological treatments for youth depression yield acute response and remission rates that are modest at best. In order to improve these outcomes, we developed and piloted a youth CBT intervention for insomnia, using R34 funding from NIMH, as an adjunct to traditional depression- focused treatment. This "indirect route" to improving depression outcomes is based on research indicating that the risk of depression is increased by insomnia, that sleep problems interfere with depression treatment success, and on emerging research on adult depression and insomnia from recent RCTs. Results from our youth pilot RCT showed promising depression and sleep outcomes. Therefore, we propose to conduct an adequately powered RCT (N=160) of our youth insomnia CBT intervention with depressed adolescents (ages 12 to 19) who have comorbid insomnia and have just initiated an incident course of treatment as usual (TAU) SSRI antidepressants (ADs). Qualified youth will be randomized to either: (a) insomnia-focused CBT (CBT-I) augmenting TAU antidepressants, or (b) a control condition of credible but minimally-effective sleep hygiene (SH) education augmenting TAU antidepressants. We will follow all youth for 12 months. We hypothesize that combined CBT-I+ADs will be superior for primary depression outcomes of response (CGI-I < 2) and major depressive disorder diagnostic remission, and primary sleep outcomes of actigraphy total sleep time and score on the Insomnia Severity Index. Secondary analyses will examine additional sleep and depression outcomes, and outcomes/mediation in two constructs relevant to the NIMH Research Domain Criteria (RDoC) initiative. Mediation analyses will examine whether improved sleep contributes to depression response-recovery. Moderation analyses will examine variation in intervention effect due to baseline age and gender, parent involvement, youth autonomy, and baseline sleep and depression severity. We will conduct economic analyses, aided by comprehensive healthcare-utilization data obtained via an integrated electronic medical record system. Should we find the predicted CBT-I benefits, cost-effectiveness results will be important for justifying next-step dissemination and implementation research. The launch of this study will be substantially expedited by the use of existing materials from our prior pilot study, including the CBT-I and SH treatment materials, and protocols. This application is responsive to priorities of the NIMH 2010 Council Workgroup Report on Interventions, in particular because of its use of personalized treatments based on individual differences; i.e., the presence of comorbid insomnia. Evidence on social/developmental and mental-health differences between youth and adults warrants a separate trial of CBT-I for youth insomnia and depression. In addition, the nature and impacts of insomnia are different for different ages, contributing to the importance of developing and testing adolescent-specific interventions for insomnia and depression.

描述（由申请人提供）：针对青少年抑郁症的心理和药物治疗产生的急性反应和缓解率充其量是适度的。为了改善这些结果，我们利用 NIMH 的 R34 资金，开发并试点了针对青少年失眠的 CBT 干预措施，作为传统抑郁症治疗的辅助手段。这种改善抑郁症结果的“间接途径”基于以下研究：失眠会增加抑郁症的风险，睡眠问题会干扰抑郁症治疗的成功，以及最近随机对照试验中关于成人抑郁症和失眠的新兴研究。我们的青少年试点随机对照试验的结果显示出有希望的抑郁和睡眠结果。因此，我们建议对患有失眠症并刚刚开始常规治疗 (TAU) SSRI 抗抑郁药的抑郁青少年（12 至 19 岁）进行一项充分有力的青少年失眠 CBT 干预随机对照试验 (N=160) （广告）。符合资格的青少年将被随机分配到：（a）以失眠为重点的 CBT（CBT-I）增强 TAU 抗抑郁药，或（b）控制条件下可信但效果最低的睡眠卫生（SH）教育增强 TAU 抗抑郁药。我们将追踪所有青少年12个月。我们假设 CBT-I+AD 组合对于原发性抑郁症缓解结果 (CGI-I < 2) 和重度抑郁症诊断缓解，以及体动记录仪总睡眠时间和失眠严重指数评分的主要睡眠结果将更有效。二次分析将检查额外的睡眠和抑郁结果，以及与 NIMH 研究领域标准 (RDoC) 倡议相关的两个结构中的结果/中介。中介分析将检查改善睡眠是否有助于抑郁反应恢复。调节分析将检查由于基线年龄和性别、父母参与、青少年自主性以及基线睡眠和抑郁严重程度而导致的干预效果的变化。我们将在通过集成电子病历系统获得的全面医疗保健利用数据的帮助下进行经济分析。如果我们发现预测的 CBT-I 效益，成本效益结果对于证明下一步传播和实施研究的合理性将非常重要。通过使用我们之前试点研究中的现有材料，包括 CBT-I 和 SH 治疗材料和方案，将大大加快这项研究的启动。该应用程序响应了 NIMH 2010 年理事会干预工作组报告的优先事项，特别是因为它使用了基于个体差异的个性化治疗；即存在共病失眠。青少年和成人之间的社会/发展和心理健康差异的证据表明，需要对青少年失眠和抑郁症进行 CBT-I 单独试验。此外，不同年龄段失眠的性质和影响也不同，因此开发和测试失眠的重要性 针对青少年失眠和抑郁症的特定干预措施。