A Hybrid Effectiveness-Implementation Multisite Trial of a Dialectical Behavior Therapy Skills Group for Veterans at High-Risk for Suicide Attempt

针对自杀未遂高风险退伍军人的辩证行为治疗技能组的混合有效性实施多地点试验

• 批准号: 10541795
• 负责人: Suzanne Elizabeth Decker
• 金额: --
• 依托单位: VA CONNECTICUT HEALTHCARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-11-01 至 2027-09-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10541795
• 关键词: Address; Administrator; Adoption; Affect; Aftercare; Characteristics; Clinic; Clinical; Clinical Practice Guideline; Clinical effectiveness; Complement; Coping Skills; Data; Development; Diagnosis; Diagnostic; Diagnostics Research; Dialectical behavior therapy; Effectiveness; Elements; Emotions; Evaluation; Feeling suicidal; Health Personnel; Hybrids; Individual; Intervention; Interview; Knowledge; Leadership; Machine Learning; Measures; Medical center; Mental Health; Mental Health Services; Mental disorders; Methodology; Methods; Outcome; Outpatients; Participant; Phase; Prevention; Process; Promoting Action on Research Implementation in Health Services framework; Psychotherapy; Published Comment; Randomized; Randomized, Controlled Trials; Research; Resources; Risk Factors; Safety; Sampling; Site; Structure; Suicide; Suicide attempt; Suicide prevention; System; Testing; Time; Veterans; clinical research site; effectiveness evaluation; effectiveness testing; effectiveness trial; effectiveness/implementation hybrid; emotion dysregulation; emotion regulation; evidence base; follow-up; formative assessment; high risk; hybrid type 1 trial; implementation barriers; implementation facilitators; implementation strategy; improved; innovation; military veteran; multi-site trial; operation; prevent; primary outcome; process improvement; programs; psychologic; randomized trial; reducing suicide; screening; skills; suicidal morbidity; suicidal risk; treatment as usual; treatment group; uptake

Abstract. Background: Suicide prevention is VHA’s highest priority. While VHA has responded by implementing new screening requirements, the REACH VET machine-learning program to identify those at high risk, and new clinical practice guidelines, these approaches do not provide Veterans at highest suicide risk with “indicated” strategies, such as psychotherapy that specifically targets suicide attempts. Reducing Veteran suicide attempts requires addressing underlying transdiagnostic psychological processes. Emotion dysregulation, or difficulty managing emotions, occurs across mental health diagnoses and is associated with higher suicide risk. Developing emotion regulation skills is a key element of effective suicide prevention. Dialectical behavior therapy (DBT) is a well-established, multi-component, evidence-based suicide prevention psychotherapy targeting emotion dysregulation that is not widely available at VHA given the complexities of implementing it. A resource-efficient, group-delivered suicide prevention psychotherapy, DBT Skills Group (DBT-SG), has been associated with reduced suicidal ideation and emotion dysregulation in VHA and non-VHA samples and was as effective as full-scale DBT in reducing suicide attempt and ideation in a non-VHA study of individuals with high suicide risk. We propose a hybrid type 1 trial to 1) evaluate the effectiveness of DBT-SG in a transdiagnostic sample of Veterans at high risk for suicide, and 2) identify individual and organizational barriers and facilitators for DBT-SG adoption in VHA facilities. Significance/ Impact: Studying DBT-SG’s clinical effectiveness and factors affecting its implementation align with the OMHSP’s National Strategy for Preventing Veteran Suicide, HSR&D, and legislative priorities to evaluate innovative interventions in high risk Veteran populations, and new VHA Clinical Practice Guidelines that encourage transdiagnostic research on DBT approaches for high-risk Veterans. Innovation: This study fills VHA and national research gaps: it is the first multisite trial to test the effectiveness of DBT-SG at VHA while simultaneously gathering generalizable knowledge about implementation barriers and facilitators. Outcomes on clinical effectiveness and barriers and facilitators will be used by OMHSP Psychotherapy and Suicide Prevention offices to inform ongoing suicide prevention initiatives. Specific Aims: (1) Test the effectiveness of DBT-SG compared to treatment-as-usual (TAU) to reduce suicide attempt and ideation in a multisite randomized trial at 4 VAMC’s; (2) Conduct a 3-part, mixed-methods formative evaluation to identify potential facilitators and barriers to DBT-SG’s successful adoption in VHA facilities. Methodology: We will randomize N=254 Veterans across 4 VAMC’s with recent suicide attempt and emotion dysregulation to DBT-SG + TAU or TAU alone to evaluate DBT-SG effectiveness. We hypothesize that DBT-SG, relative to TAU, will be associated with (H1a, primary outcome) reduced suicide attempt during 18-month follow-up, (H2b) increased survival time for suicide attempt, and (H2c) reduced suicidal ideation. Exploratory analyses will assess change in emotion dysregulation and coping skills. In addition, before, during and after the trial, we will conduct a mixed-method formative evaluation, guided by the Integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) framework, to identify DBT-SG implementation barriers and facilitators. At each juncture, we will seek input from 60 key clinical and administrative stakeholders drawn from VHA national and local leadership, VHA clinicians, and Veterans at high risk for suicide. Implementation/Next Steps: Effectiveness trial data about the prevention or delay of suicide attempts will determine the appropriateness of DBT-SG for more widespread VHA implementation. If DBT-SG is effective, the 3-part formative evaluation data will be used to develop a national VA DBT-SG implementation strategy with OMHSP’s Psychotherapy Office as the operations partner. In each project year, we will disseminate study findings to Veterans, VHA clinicians, and VHA local and national leadership.

抽象。 背景：自杀预防是VHA的最高优先事项。虽然VHA通过实施新的 筛选要求，REACH VET机器学习计划，以确定那些处于高风险， 临床实践指南，这些方法不提供退伍军人在最高自杀风险与“指示” 战略，如专门针对自杀企图的心理治疗。减少退伍军人自杀企图 需要解决潜在的transdiagnosis心理过程。情绪失调，或困难 管理情绪，发生在心理健康诊断中，并与更高的自杀风险相关。 发展情绪调节技能是有效预防自杀的关键因素。辩证行为 DBT是一种成熟的、多成分的、循证的自杀预防心理治疗 鉴于实施的复杂性，VHA没有广泛提供针对情绪失调的治疗。 资源有效，小组提供的自杀预防心理治疗，DBT技能小组（DBT-SG），已 与VHA和非VHA样本中自杀意念和情绪失调的减少相关， 在一项对患有以下疾病的个体进行的非VHA研究中， 高自杀风险。我们提出了一个混合1型试验，以1）评估DBT-SG在 高自杀风险退伍军人的跨诊断样本，2）识别个人和组织障碍 以及VHA设施采用DBT-SG的促进者。意义/影响：研究DBT-SG的临床 有效性和影响其实施的因素与OMHSP的国家预防战略相一致 退伍军人自杀，HSR&D和立法优先事项，以评估高风险退伍军人的创新干预措施 新的VHA临床实践指南鼓励对DBT进行跨诊断研究 高风险退伍军人的方法。创新：这项研究填补了VHA和国家研究的空白：它是第一个 多中心试验，以测试DBT-SG在VHA中的有效性，同时收集可推广的 了解实施障碍和促进因素。临床有效性和障碍的结局， OMHSP心理治疗和自杀预防办公室将使用辅导员来告知正在进行的自杀 预防举措。具体目的：（1）测试DBT-SG与常规治疗相比的有效性 (TAU)在4个VAMC的多地点随机试验中减少自杀企图和意念;（2）进行3部分， 混合方法的形成性评价，以确定潜在的促进因素和障碍，以DBT-SG的成功 在VHA设施中采用。方法：我们将随机分配N=254名退伍军人，来自4个VAMC，最近 自杀企图和情绪失调的DBT-SG + TAU或单独的TAU，以评估DBT-SG的有效性。 我们假设，相对于TAU，DBT-SG将与（H1 a，主要结局）减少自杀相关 在18个月随访期间，（H2 b）自杀企图的生存时间增加，（H2 c）自杀企图的生存时间减少 自杀意念探索性分析将评估情绪失调和应对技能的变化。在 此外，在试验之前、期间和之后，我们将进行混合方法的形成性评估， 卫生服务研究实施综合促进行动（i-PARIHS）框架， DBT-SG实施障碍和促进因素。在每一个关键时刻，我们将寻求60个关键临床和 来自VHA国家和地方领导层、VHA临床医生和退伍军人的行政利益相关者， 自杀风险高。实施/后续步骤：关于预防或延迟的有效性试验数据 自杀企图将决定DBT-SG是否适合更广泛的VHA实施。如果 DBT-SG是有效的，3部分形成性评价数据将用于开发国家VA DBT-SG 与OMHSP的心理治疗办公室作为业务合作伙伴，在每个项目年度， 我们将向退伍军人、VHA临床医生以及VHA地方和国家领导人传播研究结果。