Depression treatments are typically less effective for young people than for adults. However, treatments rarely target loneliness, which is a key risk factor in the onset, maintenance and development of depression.

This study evaluated the efficacy of a novel loneliness intervention, Groups 4 Health (G4H), relative to the best-practice treatment of cognitive–behavioural therapy (CBT) in reducing loneliness and depression over a 12-month period (Australian New Zealand Clinical Trial Registry: ACTRN12618000440224).

The study was a phase 3 randomised non-inferiority trial comparing G4H with dose-controlled group CBT. Participants were 174 people aged 15–25 years experiencing loneliness and clinically significant symptoms of depression, who were not in receipt of adjunct treatment. Participants were recruited from mental health services in Southeast Queensland, Australia. Randomisation was conducted using computer software. Follow-up assessments and statistical analyses were masked to allocation. Both interventions consisted of five 75 min group-based psychotherapy sessions. The primary outcomes were depression and loneliness, with a non-inferiority margin of 2.20 for depression.

The trial enrolled 174 participants between 24 April 2018 and 25 May 2019, with 84 in the G4H condition and 90 in the CBT condition. All randomised participants were included in the intention-to-treat analyses (n = 174). The pre–post effect sizes for depression were dG4H = −0.71 and dCBT = −0.91. For loneliness, they were dG4H = −1.07 and dCBT = −0.89. At 12-month follow-up, the absolute difference between groups on depression was 1.176 (95% CI −1.94 to 4.29) and on loneliness it was −0.679 (95% CI −1.43 to 0.07). No adverse effects were observed.

G4H was non-inferior to CBT for depression and showed a slight advantage over CBT for loneliness that emerged after treatment completion.

抑郁症治疗对年轻人的效果通常不如成年人。然而，治疗很少针对孤独感，而孤独感是抑郁症发作、维持和发展的关键风险因素。

本研究评估了一种新型孤独干预措施，第 4 组健康 (G4H)，相对于认知行为疗法 (CBT) 的最佳实践治疗在 12 个月内减少孤独感和抑郁症的效果（澳大利亚新西兰临床试验注册表：ACTRN12618000440224）。

该研究是一项比较 G 4 H 与剂量控制组 CBT的 3 期随机非劣效性试验。参与者是 174 名年龄在 15-25 岁之间的人，他们有孤独感和临床上显着的抑郁症状，他们没有接受辅助治疗。参与者是从澳大利亚昆士兰东南部的心理健康服务机构招募的。使用计算机软件进行随机化。后续评估和统计分析被掩盖到分配。两种干预措施都包括五个 75 分钟的小组心理治疗课程。主要结果是抑郁和孤独，抑郁的非劣效性为 2.20。

该试验在 2018 年 4 月 24 日至 2019 年 5 月 25 日期间招募了 174 名参与者，其中 84 人处于 G 4 H 状态，90 人处于 CBT 状态。所有随机参与者都包括在意向治疗分析中（n = 174）。抑郁症的前后效应大小为d G4H = -0.71 和d CBT = -0.91。对于孤独感，它们是d G4H = -1.07 和d CBT = -0.89。在 12 个月的随访中，抑郁组之间的绝对差异为 1.176（95% CI -1.94 至 4.29），而孤独组之间的绝对差异为 -0.679（95% CI -1.43 至 0.07）。没有观察到不良反应。

G4H 在抑郁症方面不劣于 CBT，并且在治疗完成后出现的孤独感方面比 CBT 略有优势。