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

项目摘要/摘要 自杀是10-14岁青少年的第二大死因和第三大死因 美国15-24岁的年轻人。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有力但被忽视的跨诊断危险因素 这是可以使用简短的、基于证据的行为治疗来改变的。尽管如此，据我们所知， 在年轻人中，失眠治疗从未与自杀治疗相结合进行过研究。这个 拟议研究的目的是进行初步可行性和初步有效性试验 将失眠和自杀/自残的循证行为治疗结合起来作为一种新的方法 预防青少年自杀。我们预计，增加以自杀为重点的失眠治疗 治疗将产生协同效应，并导致自我伤害(SH)行为和自杀行为的更大程度减少 意念(SI)比单纯以自杀为主的治疗更有效。我们将使用辩证行为疗法(DBT)作为 本研究的自杀治疗和互联网传递的数字认知行为治疗 (DCBTI)作为对失眠的重点睡眠干预。我们将从一项小型公开试验开始，以获得意见。 来自五名青年及其DBT治疗师的通知拟议的可行性试验，将方案调整为 需要加强青年对dCBTI的参与。然后，我们将使用修改后的协议进行试点RCT 对于40名12-18岁的年轻人，有失眠和高自杀风险至6个月的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，以及对失眠症状的缓解。 严重性、SH和SI。在基线评估之后，将每隔一段时间测量失眠、SI和SH结果 在24周的治疗期内持续4周，使我们能够检查缓解的时间以及增加 统计能力和减轻自然减员的影响。探索性分析将检查失眠的减少 在SH和SI中，任何观察到的状态间差异都是通过症状严重程度来调节的。尽我们最大努力 知识，这将是第一次探索两者结合的有效性的循证研究 针对青少年的失眠治疗和以自杀为主的治疗。我们认为，结合的方法 现有的两种针对自杀风险因素的循证治疗是创新和新颖的，以及 很实用。这一方法与《2022年NIMH研究战略计划》目标3.2：发展是一致的 调整现有干预措施以优化结果的战略。通过利用我们现有的治疗方法 我们已经了解工作并在现实世界中有很强的理解能力，我们减少了治疗开发所花费的时间 并可以更快地传播，如果这种方法被证明有效的话。如果dCBTI+DBT有效，我们的 目标是将dCBTI作为任何以自杀为重点的治疗的辅助手段广泛传播。

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.