Improving the Mental Health of Working Adults in Dutch Small and Medium-Sized Enterprises (SMEs): A Cluster RCT of WHO's Doing What Matters in Times of Stress (DWM)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 518
- 试验地点
- 2
- 主要终点
- Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)
研究概览
简要总结
The goal of this cluster randomized controlled trial is to explore if mental health in Dutch small and medium-sized enterprises (SMEs) can be improved by the World Health Organization's online program Doing What Matters in Times of Stress (DWM). The main questions it aims to answer are:
- Does DWM improve the mental health of employees working in Dutch SMEs?
- Does DWM improve work-related outcomes in employees working in Dutch SMEs?
- How can DWM be implemented at a large scale in Dutch SMEs?
Researchers will compare two groups to see if the DWM program is effective. One group will receive the DWM program and Care-as-Usual (group 1), and the other group will receive Care-as-Usual only (group 2).
Participants will:
- Follow the online DWM program for 5 weeks (only group 1).
- Take part in 6 telephone appointments with a facilitator (helper) that provides extra support to complete the program (only group 1).
- Complete 3 sets of questionnaires. Each set of questionnaire takes about 15 minutes to be completed (group 1 and group 2).
详细描述
Rationale: Small and medium-sized enterprises (SMEs) often lack the resources to combat the negative consequences of work stressors (e.g., high workplace digitalization). This puts their employees at risk of developing mental health problems. Literature on effective interventions at work for SME employees' mental health is scarce and inconclusive. This project focuses on the implementation of Doing What Matters in Times of Stress (DWM), a scalable, low-intensity, online psychological intervention developed by the World Health Organization (WHO) and adapted for use in Dutch SMEs. This study is part of the larger EU H2022-ADVANCE project, which aims to improve the mental health of vulnerable populations in Europe.
Objective: The main objective is to assess the (cost-)effectiveness of DWM in improving the mental health and work outcomes in employees of Dutch SMEs. Another objective is to identify a) barriers and facilitators to intervention engagement and adherence and b) opportunities and budget impact for scaling up the implementation of the interventions within the context of working adults in Dutch SMEs.
Study design: The first phase of this study concerns a cluster randomized controlled trial (cRCT) comparing DWM and care-as-usual (CAU) to CAU only. Main and secondary outcomes will be assessed at baseline (week 1), 1 week after completion of the 5-week intervention (week 7), and at 3-month follow-up (week 18) which is approximately 12 weeks after the end of the intervention. The second phase consists in the qualitative process evaluation that pertains individual interviews and/or focus group discussions.
Study population: In the first phase, the population is working adults in Dutch SMEs with self-reported elevated psychological distress. The aim is to include in the trial a total of 74 SMEs (37 per study arm) and to include five to 10 employees per SME (on average of seven employees; 259 per study arm, total N = 518), to detect a significant reduction in symptoms of depression and anxiety of Cohen's d of 0.34 at 1-week post-intervention (power=0.80, two-sided alpha=0.05, ICC=0.01, 30% attrition).
In the qualitative process evaluation, the population is: participants who completed DWM and improved (n=10), who did not improve (n=10), and who dropped-out during DWM (n=10); facilitators of DWM (n=5-10); representatives of SMEs, occupational health advocacy umbrella organisations and SME umbrella organisations (n=10).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having 10 to 250 employees
- •Being located in the Netherlands
- •In case of insufficient recruitment among SMEs, a mitigation strategy is to recruit public and non-profit organizations, and units of larger organizations, all employing between 10 and 250 employees.
- •Inclusion Criteria (Individual participants):
- •18 years or older
- •Having elevated levels of psychological distress (Kessler Psychological Distress Scale; K10 scores > 15.9)
- •Sufficient literacy and mastery (written and spoken) of one of the languages the DWM intervention is being delivered in (i.e., Dutch or English)
- •Having access to an electronic device with internet access to follow the intervention
- •Written informed consent before entering the study
排除标准
- •(Individual participants):
- •Imminent suicide risk, or expressed acute needs or protection risks that require immediate follow-up
- •Currently receiving specialized psychological treatment (e.g., EMDR or CBT) at the time of screening
- •In case of current psychotropic medication use: being on an unstable dose for at least 2 months or a change in dosage over the past 2 months.
- •Having participated in the preceding ASCEND trial as supervisor (see NCT ID: NCT06989398)
研究组 & 干预措施
Doing What Matters in Times of Stress & Care-as-Usual (CAU)
Treatment group will receive the guided-online Doing What Matters in Times of Stress (DWM) program. The program has 5 modules and is delivered in 5 weeks (one module is being made available each week).
Treatment group also receives a weekly support call (15 minutes) from a helper (6 calls in total). Helpers are (graduate) psychology students trained according to the WHO training manual in order to provide support to participants in completing the DWM program.
Participants in treatment group will be allowed to receive any usual care once they are enrolled in the trial.
干预措施: Doing What Matters in Times of Stress (Behavioral)
Care-as-Usual (CAU)
Care-as-Usual ranges from community care to specialised psychological treatments.
结局指标
主要结局
Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)
时间窗: Change from Baseline (week 1) to 1-week post intervention (week 7)
The PHQ-ADS is the sum of the PHQ-9 and GAD-7 scores (details of both instruments summarised below) and thus can range from 0 to 48, with higher scores indicating higher levels of depression and anxiety symptomatology.
次要结局
- Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)(Change from Baseline (week 1) to 3 months follow-up (week 18))
- Generalized Anxiety Disorder (GAD-7) questionnaire(Change from Baseline (week 1) to 1-week post intervention (week 7) and 3 months follow-up (week 18))
- Client Service Receipt Inventory (CSRI)(Change from Baseline (week 1) to 1-week post intervention (week 7) and 3 months follow-up (week 18))
- Patient Health Questionnaire (PHQ-9)(Change from Baseline (week 1) to 1-week post intervention (week 7) and 3 months follow-up (week 18))
- Burnout Assessment Tool (BAT-4)(Change from Baseline (week 1) to 1-week post intervention (week 7) and 3 months follow-up (week 18))
- Utrecht Work Engagement Scale (UWES-3)(Change from Baseline (week 1) to 1-week post intervention (week 7) and 3 months follow-up (week 18))
- EQ-5D-5L(Change from Baseline (week 1) to 1-week post intervention (week 7) and 3 months follow-up (week 18))
- Mainz Inventory of Microstressors (MIMIS) - adapted(Change from Baseline (week 1) to 1-week post intervention (week 7) and 3 months follow-up (week 18))
- Ultra-Brief Self-Stigma of Seeking Help Scale (SSOSH-3)(Change from Baseline (week 1) to 1-week post intervention (week 7) and 3 months follow-up (week 18))
- Absenteeism and Presenteeism(Change from Baseline (week 1) to 1-week post intervention (week 7) and 3 months follow-up (week 18))
研究者
Marit Sijbrandij
Full Professor
VU University of Amsterdam