Boucher Eliane M, Ward Haley E, Stafford Julia L, Parks Acacia C
Happify Health, New York, NY, United States.
JMIR Res Protoc. 2021 Apr 19;10(4):e25545. doi: 10.2196/25545.
Stress is an important transdiagnostic risk factor in adolescence and predicts a host of physical and psychological problems in adolescence and adulthood. Adolescence is also a developmental stage in which people may be more sensitive or reactive to stress. Indeed, research has shown that adolescents report high levels of stress, particularly when enrolled in school. However, adolescents report engaging in few, if any, stress management techniques. Consequently, the development of effective programs to help address adolescent stress is particularly important. To date, most stress management programs for adolescents are delivered within schools, and the evidence for such programs is mixed. Furthermore, most of these programs rely on traditional stress management techniques rather than incorporating methods to address the underlying negative cognitive processes, such as rumination, that may contribute to or exacerbate the effects of perceived stress.
The aim of this study is to test the short-term effects of a digital mental health program designed for adolescents aged 13-17 years on perceived stress and rumination.
This is a randomized controlled trial in which adolescents between the ages of 13 and 17 years, with elevated levels of perceived stress and brooding, will be randomly assigned to complete 8 weeks of a digital mental health program (Happify for Teens) or to a corresponding wait-list control group. The study will take place over 3 months, including the 8-week intervention period and 1-month postintervention follow-up. The primary outcome, perceived stress, along with secondary and exploratory outcomes (ie, brooding, optimism, sleep disturbance, and loneliness) will be assessed via self-report at baseline, 4 weeks, 8 weeks, and 12 weeks to compare changes in these outcomes across conditions.
Recruitment is expected to begin in the second quarter of 2021, with a target sample size of 800 participants (400 per condition). Participants will begin the study as they are recruited and will finish in waves, with the first wave of data expected 8 weeks after recruitment begins and the final wave of data expected by the end of the third quarter of 2021.
Although school-based stress management programs for adolescents are common, research suggests that they may be limited in their reach and more effective for school-based stress than other types of stress. This trial will be one of the first attempts to examine the potential benefits of a digital mental health program on adolescents to address stress along with negative cognitive processes such as rumination. If successful, this would help introduce a more scalable alternative to school-based programs that offers adolescents greater privacy while also providing insight into novel ways to target adolescent mental health more generally.
ClinicalTrials.gov NCT04567888; https://clinicaltrials.gov/ct2/show/NCT04567888.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/25545.
压力是青少年时期一个重要的跨诊断风险因素，它预示着青少年期及成年期的一系列身体和心理问题。青少年时期也是一个人可能对压力更为敏感或反应更强的发育阶段。事实上，研究表明青少年报告的压力水平很高，尤其是在上学期间。然而，青少年报告称很少（如果有的话）采用压力管理技巧。因此，开发有效的项目来帮助应对青少年压力尤为重要。迄今为止，大多数针对青少年的压力管理项目是在学校开展的，而此类项目的证据参差不齐。此外，这些项目大多依赖传统的压力管理技巧，而非纳入应对潜在负面认知过程（如反刍思维）的方法，这些负面认知过程可能会导致或加剧感知到的压力的影响。
本研究的目的是测试一款为13至17岁青少年设计的数字心理健康项目对感知压力和反刍思维的短期影响。
这是一项随机对照试验，13至17岁、感知压力水平较高且有沉思倾向的青少年将被随机分配，一组完成为期8周的数字心理健康项目（青少年版Happify），另一组作为相应的等待名单对照组。该研究将持续3个月，包括8周的干预期和干预后1个月的随访。主要结局指标感知压力，以及次要和探索性结局指标（即沉思、乐观、睡眠障碍和孤独感）将在基线、4周、8周和12周通过自我报告进行评估，以比较不同组间这些结局指标的变化。
预计招募工作将于2021年第二季度开始，目标样本量为800名参与者（每组400名）。参与者将在招募后开始研究，并分批次完成，预计招募开始8周后获得第一批数据，2021年第三季度末获得最后一批数据。
虽然针对青少年的校内压力管理项目很常见，但研究表明，它们的覆盖范围可能有限，且对校内压力的效果比对其他类型压力的效果更显著。本试验将是首批尝试研究数字心理健康项目对青少年应对压力及反刍思维等负面认知过程潜在益处的试验之一。如果成功，这将有助于引入一种比校内项目更具可扩展性的替代方案，为青少年提供更大的隐私空间，同时也能更全面地洞察针对青少年心理健康的新方法。
ClinicalTrials.gov NCT04567888；https://clinicaltrials.gov/ct2/show/NCT04567888。
国际注册报告识别码（IRRID）：PRR1-10.2196/25545。
