@Article{info:doi/10.2196/37292, author="Fassnacht, Daniel B and Ali, Kathina and van Agteren, Joep and Iasiello, Matthew and Mavrangelos, Teri and Furber, Gareth and Kyrios, Michael", title="A Group-Facilitated, Internet-Based Intervention to Promote Mental Health and Well-Being in a Vulnerable Population of University Students: Randomized Controlled Trial of the Be Well Plan Program", journal="JMIR Ment Health", year="2022", month="May", day="5", volume="9", number="5", pages="e37292", keywords="COVID-19; mental health; well-being; depression; anxiety; online; digital; intervention; Be Well Plan; health outcome; online health; digital health; health intervention; primary outcome; cognition; randomized control trial; resilience; participant satisfaction; student", abstract="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 (F1,162=9.65, P=.002, Cohen d=0.48) and resilience (F1,162=7.85, P=.006, Cohen d=0.44) showed significant time {\texttimes} 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 ", issn="2368-7959", doi="10.2196/37292", url="https://mental.jmir.org/2022/5/e37292", url="https://doi.org/10.2196/37292", url="http://www.ncbi.nlm.nih.gov/pubmed/35471196" }