针对青少年和青年抑郁症患者的意识、恢复力及行动训练的临床效果：一项多中心随机对照试验的试点阶段

Clinical effectiveness of training for awareness, resilience, and action for adolescents and young adults with depression: The pilot phase of a multicenter randomized controlled trial.

作者信息

Ekbäck Erik, Rådmark Lina, Granåsen Gabriel, Svärling Rachel, Sörlin Matilda, Schönbeck Caspar, Henje Eva

机构信息

Child and Adolescent Psychiatry, Department of Clinical Science, Umeå University, Umeå, Sweden.

Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden.

出版信息

Front Psychiatry. 2023 Mar 31;14:1130035. doi: 10.3389/fpsyt.2023.1130035. eCollection 2023.

DOI:10.3389/fpsyt.2023.1130035

PMID:37065894

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10102586/

Abstract

BACKGROUND

Depression is a top-ranking global health concern increasing in magnitude. Available treatments for adolescents and young adults are not convincingly effective and relapse rates remain high. Training for Awareness, Resilience and Action (TARA) is a group treatment program targeting specific pathophysiological mechanisms of depression in young people. TARA is feasible, acceptable, preliminarily efficacious in depressed American adolescents, and it affects postulated brain-circuitry.

METHODS

As an initial step of a multicenter randomized controlled trial (RCT) we performed a single-arm multicenter pilot-study on TARA. Thirty-five depressed individuals (15-21 years old, 28 females) received TARA for 12 weeks face-to-face or online. Data was collected before (T0), during, and after the intervention (T1). The trial was pre-registered at clinicaltrials.gov, NCT Registration: identifier [NCT04747340]. Feasibility outcomes included recruitment, attendance rates, and session ratings. Adverse events were recorded weekly and extracted from medical records at the end of the trial. Primary effectiveness outcome was self-rated depression severity on Reynolds Adolescent Depression scale 2nd ed. at T1. Secondary outcomes were Children's Depression Rating Scale-revised (CDRS-R) and Multidimensional Anxiety Scale for Children (MASC) at T1.

RESULTS

TARA was feasible and safe in the present trial. No significant RADS-2-change was seen (adjusted mean difference -3.26, 95 % CI -8.35 to 1.83; = 0.20), however a significant decrease in CDRS-R scores is reported (adjusted mean difference -9.99, 95% CI -14.76 to -5.22; < 0.001). MASC-scores did not change significantly (adjusted mean difference 1.98, 95% CI -0.96 to 4.91; =0.18). Additional feasibility aspects are presented and discussed.

DISCUSSION

Limitations include substantial loss-to-follow-up, no randomization to control, and that some participants received concomitant treatment(s). The Coronavirus pandemic complicated both implementation and interpretation of the trial. In conclusion TARA was feasible and safe in depressed adolescents and young adults. Preliminary signs of effectiveness were seen. The initiated RCT will be important and worthwhile to conduct, and several improvements to the design are suggested based on the present results.

CLINICAL TRIAL REGISTRATION

clinicaltrials.gov, identifier NCT04747340.

摘要

背景

抑郁症是一个日益严重的全球首要健康问题。针对青少年和青年的现有治疗方法效果并不令人信服，复发率仍然很高。意识、恢复力和行动训练（TARA）是一项针对年轻人抑郁症特定病理生理机制的团体治疗项目。TARA在美国抑郁症青少年中是可行的、可接受的，初步有效，并且会影响假定的脑回路。

方法

作为一项多中心随机对照试验（RCT）的第一步，我们对TARA进行了一项单臂多中心试点研究。35名抑郁症患者（15 - 21岁，28名女性）通过面对面或在线方式接受了为期12周的TARA治疗。在干预前（T0）、干预期间和干预后（T1）收集数据。该试验已在clinicaltrials.gov上预先注册，NCT注册号：标识符[NCT04747340]。可行性结果包括招募情况、出勤率和课程评分。每周记录不良事件，并在试验结束时从医疗记录中提取。主要有效性结果是在T1时使用雷诺兹青少年抑郁量表第二版进行的自评抑郁严重程度。次要结果是在T1时的儿童抑郁评定量表修订版（CDRS - R）和儿童多维焦虑量表（MASC）。

结果

在本试验中，TARA是可行且安全的。未观察到RADS - 2有显著变化（调整后平均差异 - 3.26，95%可信区间 - 8.35至1.83；P = 0.20），然而报告显示CDRS - R评分有显著下降（调整后平均差异 - 9.99，95%可信区间 - 14.76至 - 5.22；P < 0.001）。MASC评分没有显著变化（调整后平均差异1.98，95%可信区间 - 0.96至4.91；P = 0.18）。还介绍并讨论了其他可行性方面。