Ekbäck Erik, Granåsen Gabriel, Svärling Rachel, Blomqvist Ida, Henje Eva
Department of Clinical Science, Umeå University, Umeå, Sweden.
Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden.
Front Psychiatry. 2021 Oct 11;12:674583. doi: 10.3389/fpsyt.2021.674583. eCollection 2021.
Depression in adolescents and young adults is an increasing global health concern. Available treatments are not sufficiently effective and relapse rates remain high. The novel group-treatment program "Training for Awareness, Resilience and Action" (TARA) targets specific mechanisms based on neuroscientific findings in adolescent depression. TARA is framed within the National Institute of Mental Health's Research Domain Criteria and has documented feasibility and preliminary efficacy in the treatment of adolescent depression. Since neurodevelopment continues well into the mid-twenties, age-adapted treatments are warranted also for young adults. Patients 15-22 years old, with either major depressive disorder (MDD) or persistent depressive disorder (PDD) according to the DSM-IV/5 or a rating >40 on the clinician rating scale Children's Depression Rating Scale-Revised (CDRS-R), will be recruited from specialized Child and Adolescent Psychiatry and local Youth-Clinics and randomized to either TARA or standard treatment, including but not limited to antidepressant medication and/or psychotherapy. Outcome measures will be obtained before randomization (T), after 3 months of treatment (T) and at 6-months- (T) and 24-months- (T) follow-up. Additionally, dose-response measures will be obtained weekly in the TARA-arm and measures for mediation-analysis will be obtained halfway through treatment (T). Primary outcome measure is Reynolds Adolescent Depression Scale (RADS-2) score at T. Secondary outcome measures include RADS-2 score at T, Multidimensional Anxiety Scale for Children at T and T, and CDRS-R at T. Additional outcome measures include self-report measures of depression-associated symptoms, systemic bio-indicators of depression from blood and hair, heartrate variability, brain magnetic resonance imaging, as well as three-axial accelerometry for sleep-objectivization. Qualitative data will be gathered to reach a more comprehensive understanding of the factors affecting adolescents and young adults with depression and the extent to which the different treatments address these factors. In summary, this article describes the design, methods and statistical analysis plan for pragmatically evaluating the clinical effectiveness of TARA. This will be the first RCT to examine the effects of TARA compared to standard treatment for adolescents and young adults with MDD or PDD. We argue that this study will extend the current knowledgebase regarding the treatment of depression. identifier [NCT04747340].
青少年和青年的抑郁症是一个日益引起全球关注的健康问题。现有的治疗方法效果不够显著，复发率仍然很高。新颖的团体治疗项目“意识、恢复力与行动训练”（TARA）基于青少年抑郁症的神经科学研究结果针对特定机制。TARA是在美国国立精神卫生研究所的研究领域标准框架内制定的，并且已证明在治疗青少年抑郁症方面具有可行性和初步疗效。由于神经发育会持续到二十多岁中期，因此也需要为青年提供适合其年龄的治疗方法。年龄在15至22岁之间、根据《精神疾病诊断与统计手册》第四版/第五版患有重度抑郁症（MDD）或持续性抑郁症（PDD）或在临床医生评定量表儿童抑郁评定量表修订版（CDRS-R）上评分>40的患者，将从专门的儿童和青少年精神病科以及当地的青少年诊所招募，并随机分为TARA组或标准治疗组，标准治疗包括但不限于抗抑郁药物和/或心理治疗。将在随机分组前（T0）、治疗3个月后（T1）以及6个月（T2）和24个月（T3）随访时获取结果测量数据。此外，将在TARA组每周获取剂量反应测量数据，并在治疗中期（T1）获取用于中介分析的测量数据。主要结局指标是T3时的雷诺兹青少年抑郁量表（RADS-2）评分。次要结局指标包括T1、T2和T3时的RADS-2评分、T1和T2时的儿童多维焦虑量表以及T1时的CDRS-R评分。其他结局指标包括与抑郁相关症状的自我报告测量、血液和头发中抑郁的系统性生物指标、心率变异性、脑磁共振成像以及用于睡眠客观化的三轴加速度计。将收集定性数据，以更全面地了解影响患有抑郁症的青少年和青年的因素，以及不同治疗方法解决这些因素的程度。总之，本文描述了务实评估TARA临床疗效的设计、方法和统计分析计划。这将是第一项比较TARA与针对患有MDD或PDD的青少年和青年的标准治疗效果的随机对照试验。我们认为这项研究将扩展当前关于抑郁症治疗的知识库。标识符 [NCT04747340]
