Background: A growing literature supports the use of internet-based interventions to improve mental health outcomes. However, most programs target specific symptoms or participant groups and are not tailored to facilitate improvements in mental health and well-being or do not allow for needs and preferences of individual participants. The Be Well Plan, a 5-week group-facilitated, internet-based mental health and well-being group intervention addresses these gaps, allowing participants to select a range of activities that they can tailor to their specific characteristics, needs, and preferences. Objective: This study aims to test whether the Be Well Plan program was effective in improving primary outcomes of mental well-being, resilience, anxiety, and depression compared to a waitlist control group during the COVID-19 pandemic; secondary outcomes included self-efficacy, a sense of control, and cognitive flexibility. The study further seeks to examine participants’ engagement and satisfaction with the program. Methods: A randomized controlled trial (RCT) was conducted with 2 parallel arms, an intervention and a waitlist control group. The intervention involved 5 weekly 2-hour sessions, which were facilitated in group format using Zoom videoconferencing software. University students were recruited via social media posts, lectures, emails, flyers, and posters. Results: Using an intentional randomization 2:1 allocation strategy, we recruited 215 participants to the trial (n=126, 58.6%, intervention group; n=89, 41.4%, waitlist control group). Of the 126 participants assigned to the intervention group, 75 (59.5%) commenced the program and were included in modified intention-to-treat (mITT) analyses. mITT intervention participants attended, on average, 3.41 sessions (SD 1.56, median 4); 55 (73.3%) attended at least 4 sessions, and 25 (33.3%) attended all 5 sessions. Of the 49 intervention group participants who completed the postintervention assessment, 47 (95.9%) were either very satisfied (n=31, 66%) or satisfied (n=16, 34%). The mITT analysis for well-being (F_1,162=9.65, P=.002, Cohen d=0.48) and resilience (F_1,162=7.85, P=.006, Cohen d=0.44) showed significant time × group interaction effects, suggesting that both groups improved over time, but the Be Well Plan (intervention) group showed significantly greater improvement compared to the waitlist control group. A similar pattern of results was observed for depression and anxiety (Cohen d=0.32 and 0.37, respectively), as well as the secondary outcomes (self-efficacy, Cohen d=0.50; sense of control, Cohen d=0.42; cognitive flexibility, Cohen d=0.65). Larger effect sizes were observed in the completer analyses. Reliable change analysis showed that the majority of mITT participants (58/75, 77.3%) demonstrated a significant reliable improvement in at least 1 of the primary outcomes. Conclusions: The Be Well Plan program was effective in improving mental health and well-being, including mental well-being, resilience, depression, and anxiety. Participant satisfaction scores and attendance indicated a high degree of engagement and satisfaction with the program. Trial Registration: Australian New Zealand Clinical Trial Registry ACTRN12621000180819; https://tinyurl.com/2p8da5sk

中文翻译：

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促进大学生弱势群体心理健康和福祉的群体促进、基于互联网的干预措施：Be Well 计划计划的随机对照试验

背景：越来越多的文献支持使用基于互联网的干预措施来改善心理健康结果。然而，大多数项目针对特定症状或参与者群体，并没有为促进心理健康和福祉的改善而量身定制，或者不允许个体参与者的需求和偏好。Be Well 计划是一项为期 5 周的团体促进、基于互联网的心理健康和福祉团体干预，解决了这些差距，允许参与者选择一系列活动，他们可以根据自己的具体特征、需求和偏好进行调整。客观的：本研究旨在测试与 COVID-19 大流行期间的候补名单对照组相比，Be Well Plan 计划在改善心理健康、复原力、焦虑和抑郁的主要结果方面是否有效；次要结果包括自我效能、控制感和认知灵活性。该研究进一步旨在检查参与者对该计划的参与度和满意度。方法：一项随机对照试验 (RCT) 采用 2 个平行组、一个干预组和一个候补对照组进行。干预涉及 5 次每周 2 小时的会议，这些会议使用 Zoom 视频会议软件以小组形式进行。通过社交媒体帖子、讲座、电子邮件、传单和海报招募大学生。结果：使用有意随机化 2:1 分配策略，我们招募了 215 名参与者参加试验（n=126, 58.6%，干预组；n=89, 41.4%，等待名单对照组）。在分配到干预组的 126 名参与者中，75 名 (59.5%) 开始了该计划并被纳入改良意向治疗 (mITT) 分析。mITT 干预参与者平均参加 3.41 次会议（标准差 1.56，中位数 4）；55 人 (73.3%) 参加了至少 4 次会议，25 人 (33.3%) 参加了所有 5 次会议。在完成干预后评估的 49 名干预组参与者中，47 名 (95.9%) 非常满意 (n=31, 66%) 或满意 (n=16, 34%)。幸福感 ( F _1,162 =9.65, P =.002, Cohen d =0.48) 和弹性 (F _1,162 =7.85, P =.006, Cohen d =0.44) 显示出显着的时间 × 组交互效应，表明两组都随着时间的推移而有所改善，但与候补名单对照组相比，Be Well Plan（干预）组的改善显着更大. 抑郁和焦虑（分别为 Cohen d = 0.32 和 0.37）以及次要结果（自我效能，Cohen d = 0.50；控制感，Cohen d = 0.42；认知灵活性，科恩_=0.65）。在更完整的分析中观察到更大的效应量。可靠的变化分析表明，大多数 mITT 参与者（58/75，77.3%）在至少一项主要结果中表现出显着的可靠改善。结论： Be Well Plan 计划在改善心理健康和幸福感方面是有效的，包括心理健康、复原力、抑郁和焦虑。参与者的满意度得分和出勤率表明对该计划的参与度和满意度很高。试验注册：澳大利亚新西兰临床试验注册ACTRN12621000180819；https://tinyurl.com/2p8da5sk