1型有效性-实施多地点混合试验研究方案：退伍军人自杀未遂高危人群辩证行为治疗技能组。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-02-07 DOI:10.1016/j.cct.2025.107828

Suzanne E. Decker , Aimee Kroll-Desrosiers , Kristin M. Mattocks , Frances M. Aunon , Elizabeth Galliford , Eric C. DeRycke , Neal Doran , Scarlett Baird , Jennifer K. Rielage , Josephine Ridley , Jenny Bannister , Thorayya S. Giovannelli , Brian S. Fuehrlein , Chris Shriver , Ethan Spana , Mark Honsberger , Stacey A. Demirelli , Elena Shest , Sara J. Landes , Marianne Goodman , Steve Martino

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引用次数: 0

摘要

背景：美国武装部队退伍军人自杀死亡的风险高得不成比例，需要明确的策略来降低这一风险。辩证行为疗法（DBT）对于减少情绪失调、重复自杀行为或自我导向暴力个体的自杀企图是有效的，但它是一种综合的、多成分的、资源密集型的治疗方法。作为一种资源效率更高的DBT组成部分，DBT技能小组作为一种辅助治疗，治疗师咨询小组（DBT- sg）在非退伍军人样本中被证明与综合DBT一样有效，但其有效性和影响其实施的因素尚未在退伍军人健康管理局（VHA）中进行研究。本研究旨在评估DBT-SG在近期和多次自杀未遂和情绪失调的高风险退伍军人中的有效性，同时系统评估实施障碍和促进因素。方法：本混合1型有效性-实施研究将采用18 个月的随机对照试验，评估DBT-SG在情绪失调的自杀未遂高风险退伍军人中的有效性。研究条件是24期DBT-SG加全谱VHA心理健康治疗（TAU），或VHA TAU。在随机化后3个月、6个月、12个月和18个月评估结果。在有效性试验之前、期间和之后，将使用基于卫生服务研究实施综合促进行动（i-PARIHS）框架的混合方法评估DBT-SG作为VHA辅助治疗的实施决定因素。结论：本研究将为DBT-SG对高自杀风险退伍军人的有效性提供证据，并提供有关障碍和促进因素的信息，以支持在VHA中更广泛地促进实施辅助DBT-SG。临床试验注册：NCT05000749。

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Study protocol of a hybrid type 1 effectiveness-implementation multisite trial: Dialectical behavior therapy skills group for Veterans at high-risk for suicide attempt

Background

Veterans of the United States Armed Forces are at disproportionately high risk for suicide death, requiring indicated strategies to mitigate that risk. Dialectical Behavior Therapy (DBT) is effective for reducing suicide attempts in individuals with emotional dysregulation and repeat suicidal behaviors or self-directed violence, but is a comprehensive, multi-component, resource-intensive treatment. A more resource-efficient component of DBT, the DBT Skills Group as an adjunctive treatment, with therapist consultation team (DBT-SG), has been shown to be as efficacious as comprehensive DBT in non-veteran samples, but its effectiveness and factors affecting its implementation have not been studied in the Veterans Health Administration (VHA). This research aims to assess the effectiveness of DBT-SG among high-risk veterans with recent and repeated suicide attempts and emotion dysregulation while systematically evaluating implementation barriers and facilitators.

Methods

This hybrid type 1 effectiveness-implementation study will evaluate DBT-SG effectiveness among veterans at high-risk for suicide attempt with emotion dysregulation using a randomized controlled trial of 18 months duration. Study conditions are 24-session DBT-SG plus full-spectrum VHA mental health treatment-as-usual (TAU), or VHA TAU. Outcomes are assessed at 3-, 6-, 12-, and 18-months post-randomization. Before, during, and after the effectiveness trial, implementation determinants of DBT-SG as an adjunctive treatment in VHA will be assessed using a mixed methods evaluation grounded in the Integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) framework.

Conclusions

This study will provide evidence for DBT-SG effectiveness for veterans at high risk for suicide and information about barriers and facilitators to support more widespread facilitation of implementing adjunctive DBT-SG in VHA if it is found effective.

Clinical trials registration: NCT05000749

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.