Clinical trial NCT06979089: Implementation of DWM in Dutch SMEs
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Depression
Psychological Distress
Keywords: Depression
Anxiety
Psychological Distress
Mental health
Work-place mental health
Employee well-being
Digital intervention
Online intervention
Doing What Matters in Times of Stress
Small and medium-sized enterprises
Lead sponsor: VU University of Amsterdam
Sponsor class: OTHER
Collaborators: name: World Health Organization
name: University of Copenhagen
name: University Hospital Heidelberg
First posted: 2025-05-18
Enrollment: 518
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The trial has cluster-randomized study design, meaning that the organizations (i.e., SMEs) that take part in the study will form clusters that will be randomized into either the intervention or control group. This way every participating employee from a SME is part of the same group.

In this trial we are applying a stratified randomization based on whether the managers of the participating SME previously received the ASCEND intervention (manager training) or were in the control condition of a preceding trial (see NCT ID: \[to be updated once available\]). The SMEs will be randomized using limited block size that varies randomly (i.e., 4, 6, or 8 SMEs per block) per each stratum across (1) DWM and CAU (n=37) or (2) CAU only (n=37), with an equal probability of assignment to each group (allocation ratio 1:1).
Primary purpose: PREVENTION

Brief summary: 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).

Detailed description: 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 psychological distress 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).

Intervention: DWM is an online intervention based on an illustrated stress management book developed by WHO. It is delivered in 5 sessions over 5 consecutive weeks, with a weekly supporting 15 minutes telephone call from a trained non-specialist facilitator (i.e., helper). DWM teaches strategies to help reduce stress such as mindfulness exercises (e.g., grounding).

Main study parameters/endpoints: The primary outcome of the cRCT will be psychological distress (combined anxiety and depression levels) at 1 week post-treatment. A decrease is anticipated in the intervention group compared to the control group, with a Cohen's d effect size of 0.34. A decrease is also anticipated in the intervention group compared to the control group in the secondary outcomes: anxiety, depression, burnout, absenteeism, presenteeism, self-stigma; and an increase in resilience, work-engagement, and quality of life Effectiveness will be assessed using linear mixed models, which account for repeated measures and clustering at the organizational/department level.

Through interviews and/or focus group discussions, the feasibility of scaling-up the implementation of the DWM intervention within the Netherlands will be examined.

Eligibility criteria: Inclusion Criteria (SMEs):

* Having 10 to 250 employees
* Being located in the Netherlands
* (In case of insufficient recruitment among SMEs, a mitigation strategy is to recruit individual departments from larger organizations)

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

Exclusion Criteria (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: \[to be updated once available\])

Primary outcomes:
measure: Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)
timeFrame: Change from Baseline (week 1) to 1-week post intervention (week 7)
Secondary outcomes:
measure: Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)
timeFrame: Change from Baseline (week 1) to 3 months follow-up (week 18)
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Change from Baseline (week 1) to 1-week post intervention (week 7) and 3 months follow-up (week 18)
measure: Generalized Anxiety Disorder (GAD-7) questionnaire
timeFrame: Change from Baseline (week 1) to 1-week post intervention (week 7) and 3 months follow-up (week 18)
measure: EQ-5D-5L
timeFrame: Change from Baseline (week 1) to 1-week post intervention (week 7) and 3 months follow-up (week 18)
measure: Client Service Receipt Inventory (CSRI)
timeFrame: Change from Baseline (week 1) to 1-week post intervention (week 7) and 3 months follow-up (week 18)
measure: Burnout Assessment Tool (BAT-4)
timeFrame: Change from Baseline (week 1) to 1-week post intervention (week 7) and 3 months follow-up (week 18)
measure: Utrecht Work Engagement Scale (UWES-3)
timeFrame: Change from Baseline (week 1) to 1-week post intervention (week 7) and 3 months follow-up (week 18)
measure: Mainz Inventory of Microstressors (MIMIS) - adapted
timeFrame: Change from Baseline (week 1) to 1-week post intervention (week 7) and 3 months follow-up (week 18)
measure: Ultra-Brief Self-Stigma of Seeking Help Scale (SSOSH-3)
timeFrame: Change from Baseline (week 1) to 1-week post intervention (week 7) and 3 months follow-up (week 18)
measure: Absenteeism and Presenteeism
timeFrame: Change from Baseline (week 1) to 1-week post intervention (week 7) and 3 months follow-up (week 18)
Other outcomes:
measure: Kessler-10 Psychological Distress Scale (K10)
timeFrame: Screening (week 1)
measure: Implementation indicator: acceptability
timeFrame: During intervention (week 2-6)
measure: Implementation indicator: acceptability
timeFrame: 1-week post intervention (week 7)
measure: Implementation indicator: appropriateness
timeFrame: 1-week post intervention (week 7)
measure: Implementation indicator: feasibility
timeFrame: 1-week post intervention (week 7)
measure: Implementation indicator: barriers and facilitators
timeFrame: 1-week post intervention (week 7)
measure: Implementation indicator: use of DWM strategies
timeFrame: 1-week post intervention (week 7) and 3 months follow-up (week 18)
Locations:
city: Amsterdam
country: Netherlands
facility: Vrije Universiteit Amsterdam
state: Noord-Holland
Study officials:
affiliation: VU University of Amsterdam
name: Marit E. Sijbrandij
role: PRINCIPAL_INVESTIGATOR
References: