Combined Dialectical Behavior Therapy and Digital Cognitive Behavioral Therapy for Insomnia for Adolescents at High Risk for Suicide: A Pilot RCT

辩证行为疗法和数字认知行为疗法相结合治疗自杀高危青少年的失眠：一项试点随机对照试验

• 批准号: 10643478
• 负责人: Michele Stacy Berk
• 金额: $ 23.18万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-15 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10643478
• 关键词: 14 year old; Address; Adolescent; Adult; Age; Behavior; Behavior Therapy; Cause of Death; Cognitive Therapy; Comorbid Insomnia; Detection; Diagnostic; Dialectical behavior therapy; Disease remission; Dropout; Effectiveness; Evidence based treatment; Feeling suicidal; Goals; International; Internet; Intervention; Interview; Investigational Therapies; Link; Measures; Mediating; Mediator; National Institute of Mental Health; Outcome; Prevention Research; Protocols documentation; Public Health; Randomized; Reporting; Research; Risk Factors; Safety; Sampling; Self-Injurious Behavior; Severities; Signal Transduction; Sleep; Sleeplessness; Speed; Strategic Planning; Suicide; Suicide prevention; Symptoms; Teenagers; Time; Treatment Protocols; United States; Work; Youth; adolescent suicide; depressive symptoms; digital; digital treatment; effectiveness research; effectiveness trial; efficacious treatment; efficacy trial; evidence base; feasibility trial; high risk; improved; inclusion criteria; innovation; neglect; novel; novel strategies; pilot trial; reducing suicide; satisfaction; sleep-focused interventions; standard care; success; suicidal; suicidal morbidity; suicidal risk; suicide rate; therapy development; therapy outcome; timeline; treatment duration; treatment trial; uptake

PROJECT SUMMARY/ABSTRACT Suicide is the 2nd leading cause of death among 10-14-year-olds and the 3rd leading cause of death among 15-24 year-olds in the United States. Reducing adolescent suicide rates is an urgent public health objective. Insomnia is a robust yet neglected transdiagnostic risk factor for suicidality and suicide deaths in adolescents that is modifiable using brief, evidence-based behavioral treatments. Despite this, to the best of our knowledge, insomnia treatments have never been studied in combination with suicide-focused treatments in youths. The purpose of the proposed research is to conduct an initial feasibility and preliminary effectiveness trial of combining evidence-based behavioral treatments for insomnia and suicidality/self-harm as a novel approach to adolescent suicide prevention. We anticipate that augmenting a suicide-focused treatment with an insomnia treatment will have a synergistic effect and lead to greater reductions in self-harm (SH) behaviors and suicidal ideation (SI) than suicide-focused treatment alone. We will use dialectical behavior therapy (DBT) as the suicide-focused treatment for the present study and internet-delivered, digital cognitive-behavioral therapy (dCBTI) for insomnia as the sleep-focused intervention. We will begin with a small open trial to obtain input from five youth and their DBT therapists to inform the proposed feasibility trial, adjusting the protocol as needed to enhance youth engagement in dCBTI. We will then use the modified protocol to conduct a pilot RCT with 40 youth, ages 12-18, with insomnia and high suicide risk to 6 months dCBTI plus DBT or to DBT alone. We will assess feasibility, acceptability, and safety of dCBTI + DBT, as well as reductions in insomnia symptom severity, SH, and SI. Following a baseline assessment, insomnia, SI and SH outcomes will be measured every 4 weeks over the 24-week treatment period to allow us to examine time to remission as well as to increase statistical power and mitigate impact of attrition. Exploratory analyses will examine if reduction in insomnia symptom severity mediates any observed between-condition differences in SH and SI. To the best of our knowledge, this will be the first study to explore the effectiveness of combining both an evidence-based insomnia treatment and a suicide-focused treatment for adolescents. We believe the approach of combining two existing evidence-based treatments that target risk factors for suicide is innovative and novel, as well as practical. This approach is consistent with the 2022 NIMH Strategic Plan for Research, Objective 3.2: Develop strategies for tailoring existing interventions to optimize outcomes. By leveraging existing treatments that we already know work and have robust uptake in the real world, we reduce time spent on treatment development and can move faster to dissemination, should the approach prove effective. If dCBTI + DBT is effective, our goal will be to disseminate dCBTI broadly as an adjunct to any suicide-focused treatment.

项目概要/摘要 自杀是 10-14 岁青少年的第二大死因，也是 10-14 岁青少年的第三大死因 美国15-24岁的人群。降低青少年自杀率是一项紧迫的公共卫生目标。 失眠是青少年自杀和自杀死亡的一个强大但被忽视的跨诊断危险因素 这是可以通过简短的、基于证据的行为治疗来改变的。尽管如此，据我们所知， 从未将失眠治疗与针对青少年的自杀治疗结合起来进行研究。这 拟议研究的目的是进行初步可行性和初步有效性试验 将针对失眠和自杀/自残的基于证据的行为疗法结合起来，作为一种新方法 青少年自杀预防。我们预计，通过失眠来加强以自杀为重点的治疗 治疗将产生协同效应，从而更大程度地减少自残（SH）行为和自杀行为 意念（SI）优于单独以自杀为中心的治疗。我们将使用辩证行为疗法（DBT）作为 本研究以自杀为中心的治疗以及互联网提供的数字认知行为治疗 （dCBTI）针对失眠作为以睡眠为重点的干预措施。我们将从一个小型的公开试验开始，以获取意见 五名青少年及其 DBT 治疗师向拟议的可行性试验提供信息，将方案调整为 需要加强青年​​人对 DCBTI 的参与。然后我们将使用修改后的方案进行试点随机对照试验 40 名 12-18 岁的青少年患有失眠和自杀风险较高，接受 6 个月 dCBTI 加 DBT 或单独 DBT。 我们将评估 dCBTI + DBT 的可行性、可接受性和安全性，以及失眠症状的减少 严重性、SH 和 SI。基线评估后，将每隔一段时间测量失眠、SI 和 SH 结果。 24 周治疗期间有 4 周，以便我们检查缓解时间以及延长时间 统计功效并减轻人员流失的影响。探索性分析将检查失眠是否减少 症状严重程度介导任何观察到的 SH 和 SI 条件之间的差异。尽我们最大的努力 知识，这将是第一项探索将基于证据的方法结合起来的有效性的研究 青少年失眠治疗和以自杀为重点的治疗。我们相信结合的方法 两种针对自杀危险因素的现有循证治疗方法具有创新性和新颖性，并且 实际的。这种方法符合 2022 年 NIMH 研究战略计划的目标 3.2：开发 调整现有干预措施以优化结果的策略。通过利用我们现有的治疗方法 已经了解工作并且在现实世界中有很强的吸收力，我们减少了治疗开发上花费的时间 如果该方法被证明有效，则可以更快地进行传播。如果 dCBTI + DBT 有效，我们的 目标是广泛传播 DCBTI，作为任何针对自杀的治疗的辅助手段。