Implementation of DWM in Dutch SMEs

NCT06979089 | Recruiting DMC

• 2 other identifiers: 2024.0852ADVANCE
• Study Type: interventional
• Target: 518
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (10)

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

  Change from Baseline (week 1) to 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)

• 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)

• EQ-5D-5L

  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)

Other Outcomes (7)

• Kessler-10 Psychological Distress Scale (K10)

  Screening (week 1)

• Implementation indicator: acceptability

  During intervention (week 2-6)

• Implementation indicator: acceptability

  1-week post intervention (week 7)

Study Arms (2)

Doing What Matters in Times of Stress & Care-as-Usual (CAU)

EXPERIMENTAL

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.

Behavioral: Doing What Matters in Times of Stress

Care-as-Usual (CAU)

NO INTERVENTION

Care-as-Usual ranges from community care to specialised psychological treatments.

Interventions

Doing What Matters in Times of Stress BEHAVIORAL

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).

Also known as: DWM, Doing What Matters, SH+, Self-Help Plus

Doing What Matters in Times of Stress & Care-as-Usual (CAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• VU University of Amsterdam: lead
• World Health Organization: collaborator
• University of Copenhagen: collaborator
• University Hospital Heidelberg: collaborator

Study Sites (1)

Vrije Universiteit Amsterdam

Amsterdam, North Holland, 1081 HV, Netherlands

RECRUITING

Related Links

• EU-ADVANCE website

MeSH Terms

Conditions

Anxiety Disorders; Depression; Psychological Well-Being; Cerebral Palsy

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Personal Satisfaction; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Marit E. Sijbrandij

  VU University of Amsterdam

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cătălin Gherdan

CONTACT

+31 20 59 82587; c.gherdan@vu.nl

Anke B. Witteveen

CONTACT

a.b.witteveen@vu.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Model Details: 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).

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 18, 2025
• Study Start: May 19, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-11

Locations

NL (1)