Recruiting

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

ClinicalTrials.gov IDNCT06979089

PhaseNA

Enrollment518

SponsorVU University of Amsterdam

Age18 Years and older

SexALL

I'm interested View official listing

Conditions studied

Anxiety, Depression, Psychological Distress

About this study

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).

Interventions

Behavioral: Doing What Matters in Times of Stress — 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).

Primary outcomes

Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) (Change from Baseline (week 1) to 1-week post intervention (week 7))

Eligibility information

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 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 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: NCT06989398)

Study locations

Vrije Universiteit Amsterdam, Amsterdam, North Holland 1081 HV Netherlands

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-16.