University of Warwick, Coventry, UK.
Warwick Medical School, Division of Health Sciences, University of Warwick, Coventry, UK.
BMJ Open. 2022 Dec 9;12(12):e060545. doi: 10.1136/bmjopen-2021-060545.
One in six workers experience some form of mental health problems at work costing the UK economy an estimated £70 billion/year. Digital interventions provide low cost and easily scalable delivery methods to implement psychological interventions in the workplace. This trial tests the feasibility of implementing a self-guided 8-week digital cognitive behavioural therapy intervention for subthreshold to clinical depression and/or anxiety versus waitlist control (ie, life as usual) in the workplace.
Feasibility of implementation will be tested using a mixed-methods evaluation of the two-arm randomised waitlist-control trial. Evaluation will include examination of organisational buy-in, and the engagement of employees through the trial indicated by the completion of outcome measures. In addition, we also explore how participants use the platform, the appropriateness of the analysis both with reference to the outcome measures and linear modelling. Finally, we examine the acceptability of the intervention based on participants experiences using qualitative interviews. Assessments take place at baseline (T0), at 8 weeks post-treatment (T1), at short-term follow-up 4 weeks post-treatment (T2) and long-term follow-ups (6 and 12 months after-end of treatment). We will recruit from 1 July 2021 to 31 December 2021 for employees and self-employed workers with depression and anxiety symptoms (subclinical and clinical levels) who are not seeking or engaged in treatment at the time of the trial.
Full approval was given by the University of Warwick Biomedical and Research Ethics Committee (BSREC 45/20-21). The current protocol version is 2.8 (August 2021). Publication of results in peer-reviewed journals will inform the scientific, clinical and business communities. We will disseminate results through webinars, conferences, newsletter as well as a lay summary of results on the study website (mhpp.me).
ISRCTN31161020.
英国经济每年因员工遭受某种形式的心理健康问题（估计有六分之一的员工会经历）而损失约 700 亿英镑。数字干预措施提供了低成本且易于扩展的交付方法，可在工作场所实施心理干预。本试验旨在测试在工作场所实施自我指导的 8 周数字认知行为疗法干预亚临床至临床抑郁和/或焦虑症与等待对照（即，正常生活）的可行性。
将使用两臂随机等待对照试验的混合方法评估来测试实施的可行性。评估将包括检查组织的投入度，以及员工通过试验参与度的指标，如完成结果测量。此外，我们还探索了参与者如何使用该平台，以及分析的适当性，包括参考结果测量和线性建模。最后，我们根据参与者的经验使用定性访谈来评估干预措施的可接受性。评估在基线（T0）、治疗后 8 周（T1）、治疗后 4 周短期随访（T2）和长期随访（治疗结束后 6 个月和 12 个月）进行。我们将于 2021 年 7 月 1 日至 2021 年 12 月 31 日招募抑郁和焦虑症状（亚临床和临床水平）的员工和自雇人士，这些人在试验期间不寻求或不参与治疗。
华威大学生物医学和研究伦理委员会（BSREC 45/20-21）已完全批准。当前协议版本为 2.8（2021 年 8 月）。在同行评议期刊上发表结果将为科学界、临床界和商界提供信息。我们将通过网络研讨会、会议、时事通讯以及在研究网站（mhpp.me）上发布结果的通俗摘要来传播结果。
ISRCTN31161020。
