Research School of Psychology, The Australian National University, Canberra, ACT, 2601, Australia.
School of Psychology, University of Queensland, Brisbane, 4072, QLD, Australia.
BMC Public Health. 2019 Jun 20;19(1):788. doi: 10.1186/s12889-019-7011-y.
BACKGROUND: Depression is the leading cause of disability in young people (aged 15-25) globally. Loneliness is a major factor in the development and relapse of depression in young people, yet few interventions directly address loneliness. Groups 4 Health (G4H) - a novel, theoretically derived group psychotherapy intervention - may address this disconnect. Previous trials (Phase I and Phase II) have found G4H to be efficacious in reducing symptoms of depression. However, the efficacy of G4H compared to current evidence-based treatments (Phase III) has not been investigated. This protocol details the design and methodology of the Connecting Adolescents to Reduce Relapse (CARR) trial, a randomised control trial assessing the efficacy of G4H in young people relative to cognitive behavioural therapy (CBT). METHODS: The CARR trial is a two-arm non-inferiority randomised controlled trial that will compare the efficacy of G4H to the most widely used evidence-based treatment for depression, CBT, at program completion and 6- and 12-month follow up. Participants will be 200 young people (aged 15-25) with symptoms of depression and/or loneliness recruited from community and university mental health services. We hypothesise that the interventions will be comparable in reducing depression symptoms, but that G4H will be superior in reducing loneliness. Because loneliness is a primary risk factor for depression relapse in young people, we therefore expect the benefits of Groups 4 Health to be particularly apparent at 12-month follow up. DISCUSSION: This trial will be the first to evaluate an intervention that targets loneliness, in comparison to the current gold standard treatment approach - CBT. If found to be effective, this program offers a new approach to treatment and relapse prevention of depression among young people. TRIAL REGISTRATION: Trial prospectively registered on ANZCTR ( ACTRN12618000440224 ), registered on 27/03/2018.
背景:抑郁症是全球(15-25 岁)年轻人致残的首要原因。孤独感是年轻人抑郁发展和复发的一个主要因素,但很少有干预措施直接针对孤独感。Groups 4 Health(G4H)是一种新颖的、基于理论的团体心理治疗干预措施,可能会解决这一脱节问题。之前的试验(I 期和 II 期)发现 G4H 能有效减轻抑郁症状。然而,G4H 与目前基于证据的治疗方法(III 期)的疗效比较尚未得到研究。本方案详细介绍了 Connecting Adolescents to Reduce Relapse(CARR)试验的设计和方法学,该试验是一项随机对照试验,评估 G4H 相对于认知行为疗法(CBT)在年轻人中的疗效。
方法:CARR 试验是一项两臂非劣效性随机对照试验,将在方案完成时和 6 个月及 12 个月随访时,比较 G4H 与最广泛使用的抑郁症循证治疗方法(CBT)的疗效。参与者将是 200 名来自社区和大学心理健康服务机构的患有抑郁和/或孤独感症状的年轻人(15-25 岁)。我们假设这两种干预措施在减轻抑郁症状方面是相当的,但 G4H 在减轻孤独感方面会更有效。因为孤独感是年轻人抑郁复发的一个主要危险因素,因此我们预计 G4H 的益处在 12 个月随访时会特别明显。
讨论:这项试验将是第一个评估针对孤独感的干预措施的试验,与目前的黄金标准治疗方法-CBT 相比。如果被证明有效,该方案为年轻人的抑郁症治疗和预防复发提供了一种新的方法。
试验注册:试验前瞻性注册于澳大利亚新西兰临床试验注册中心(ANZCTR)(ACTRN12618000440224),注册于 2018 年 3 月 27 日。
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