AzTrials
AzTrials

AnxietyNCT06979089

Implementation of WHO's Doing What Matters in Times of Stress in Dutch Small and Medium-sized Enterprises (SMEs)

A study testing Doing What Matters in Times of Stress in people with Anxiety and Depression, run by VU University of Amsterdam at 1 site in Netherlands.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anxiety, Depression, Psychological Distress
What is being tested?
Doing What Matters in Times of Stress
Could I receive a placebo?
No, everyone receives an active treatment
How many people
518 participants
Where
1 siteNetherlands
Study dates
19 May 2025to Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Cătălin Gherdan contact

+31 20 59 82587

c.gherdan@vu.nl

Anke B. Witteveen contact

a.b.witteveen@vu.nl

Netherlands1 site, 1 recruiting
  • Vrije Universiteit Amsterdam

    Amsterdam, North Holland, 1081 HV

    Cătălin Gherdan, +31 20 59 82587, c.gherdan@vu.nl

    Recruiting

Other trials in Netherlands

About this study

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)

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?
Read more

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).
Read the 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 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).

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 the reduction in symptoms of depression and anxiety from baseline to 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 work-engagement. Effectiveness will be assessed using linear mixed models, which account for repeated measures and clustering at the organizational 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.

Being tested
Doing What Matters in Times of Stress
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
Medical subject headings
Anxiety Disorders, Depression, Psychological Well-Being, Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Doing What Matters in Times of StressBehavioural

    Also called DWM, Doing What Matters, SH+, Self-Help Plus

    DWM is the illustrated guide of the original stress management intervention - Self-Help Plus and can be offered online through a web-based application.

    DWM is a low-intensity and transdiagnostic intervention that has been designed to be widely applicable to a variety of mental health problems (depression, anxiety and PTSD). DWM is based on acceptance and commitment therapy (ACT), a modern form (third wave) of cognitive-behavioural therapy with a strong focus on mindfulness practices and identification of values, with exercises which aim to reduce distress and build social support, adaptive coping and resilience.

    DWM includes five modules, each of which focuses on a specific skill. The online version of DWM has been designed to release a module every week, so the program is finalized in 5 weeks. In this trial, participants will receive the guided version of DWM: participants will have a short (15 minutes) weekly support call with a helper (6 calls in total).

Study groups in NCT06979089
Study groupRoleWhat they receive
Doing What Matters in Times of Stress & Care-as-Usual (CAU)ExperimentalTreatment 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.
Receives: Behavioral: Doing What Matters in Times of Stress
Care-as-Usual (CAU)No interventionCare-as-Usual ranges from community care to specialised psychological treatments.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)

    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.

    Measured: Change from Baseline (week 1) to 1-week post intervention (week 7)

Secondary outcomes (7)
  1. Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)

    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.

    Measured: Change from Baseline (week 1) to 3 months follow-up (week 18)

  2. Patient Health Questionnaire (PHQ-9)

    PHQ-9 is a self-report measure of depression. The 9 items are scored on a 4-point scale ranging from 0 (Not at all) to 3 (Nearly every day). Scores range from 0 to 27 and higher scores indicate higher levels of depression.

    Measured: Change from Baseline (week 1) to 1-week post intervention (week 7) and 3 months follow-up (week 18)

  3. Generalized Anxiety Disorder (GAD-7) questionnaire

    GAD-7 is a self-report measure of anxiety. The 7 items are scored on a 4-point scale ranging from 0 (Not at all) to 3 (Nearly every day). Scores range from 0 to 21 and higher scores indicate higher levels of anxiety.

    Measured: Change from Baseline (week 1) to 1-week post intervention (week 7) and 3 months follow-up (week 18)

  4. Burnout Assessment Tool (BAT-4)

    BAT-4 is a self-report measure of burnout. The 4 items are scored on a 5-point scale ranging from 1 (Never) to 5 (Always). Sores range from 1 to 5 and higher scores indicate higher levels of burnout.

    Measured: Change from Baseline (week 1) to 1-week post intervention (week 7) and 3 months follow-up (week 18)

  5. Utrecht Work Engagement Scale (UWES-3)

    UWES-3 is a self-report measure of work-engagement. The 3 items are scored on a 7-point scale ranging from 0 (Never) to 6 (Always/Every day). Scores range from 0 to 6 and higher scores indicate higher levels of work engagement.

    Measured: Change from Baseline (week 1) to 1-week post intervention (week 7) and 3 months follow-up (week 18)

  6. Ultra-Brief Self-Stigma of Seeking Help Scale (SSOSH-3)

    SSOSH-3 is a self-report measure of stigma related to mental health help-seeking behaviour. The 3 items are scored on a 5-point scale ranging from 1 (Strongly disagree) to 5 (Strongly agree). Scores range from 3 to 15. Higher scores indicate higher levels of stigma.

    Measured: Change from Baseline (week 1) to 1-week post intervention (week 7) and 3 months follow-up (week 18)

  7. Absenteeism and Presenteeism

    Absenteeism and presenteeism will be self-reported using single-item measures.

    Absenteeism: How many days have you been absent from work in the last 4 weeks due to illness?

    Presenteeism: How many days have you been less productive than usual at work in the last 4 weeks due to illness?

    Measured: Change from Baseline (week 1) to 1-week post intervention (week 7) and 3 months follow-up (week 18)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2025
  2. Study start19 May 2025
  3. Primary completionMar 2027 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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: NCT06989398). 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).
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
518 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06979089
Sponsor's protocol ID
2024.0852
Other IDs
ADVANCE
Status last verified
Jul 2026
First submitted
7 May 2025
Last updated
16 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Doing What Matters in Times of Stress in people with Anxiety and Depression, run by VU University of Amsterdam at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Cătălin Gherdan (+31 20 59 82587, c.gherdan@vu.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) (time frame: Change from Baseline (week 1) to 1-week post intervention (week 7)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in