Implementation of WHO's Doing What Matters in Times of Stress in Dutch Small and Medium-sized Enterprises (SMEs)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVU University of Amsterdam
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Having 10 to 250 employees
Being located in the Netherlands
18 years or older
Having elevated levels of psychological distress (Kessler Psychological Distress Scale; K10 scores > 15.9)
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Doing What Matters in Times of Stress
BehavioralDWM 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).
Treatment groups
518 Participants
are divided into 2 treatment groupsGroup A: Doing What Matters in Times of Stress & Care-as-Usual (CAU)Experimental treatment 1 intervention
Group B: Care-as-Usual (CAU)No intervention 0 interventions
Trial outcomes
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.
Time frame
Change from Baseline (week 1) to 1-week post intervention (week 7)Secondary 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.
Time frame
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.
Time frame
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.
Time frame
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.
Time frame
Change from Baseline (week 1) to 1-week post intervention (week 7) and 3 months follow-up (week 18)Other outcomes
1
Kessler-10 Psychological Distress Scale (K10)
K10 is a self-report measure of psychological distress. The 10 items are scored on a 5-point scale ranging from 1 (None of the time) to 5 (All of the time). Scores range from 10 to 50. Higher scores indicate higher psychological distress. In this study, the K10 is used as a screening tool, with a score greater than 15.9 indicating (at least) moderate psychological distress.
Time frame
Screening (week 1)2
EQ-5D-5L
EQ-5D-5L is a self-report measure of quality of life. Problems experienced under 5 life domains are scored on a 5-point scale, ranging from 'No problems' to 'Extreme problems'. Higher scores indicate lower quality of life. Additionally, the current health status is measured through a visual analogue scale ranging from 'The worst health you can imagine' to 'The best health you can imagine'.
Time frame
Baseline (week 1), 1-week post intervention (week 7) and 3 months follow-up (week 18)3
Client Service Receipt Inventory (CSRI)
The (mental) healthcare service utilization and related costs will be measured using the locally adapted version of the Client Service Receipt Inventory (CSRI).
Time frame
Baseline (week 1), 1-week post intervention (week 7) and 3 months follow-up (week 18)4
Mainz Inventory of Microstressors (MIMIS) - adapted
MIMIS is a self-report measure of (micro)stressors experienced that consists of two parts. The first part includes three questions that measure the extent to which individuals were affected by major life events. The questions are rated on a 5-point scale, with answers ranging from from 0 (This situation did not happen) to 4 (Severe impact). Higher scores indicate a higher impact. The second part consists of 19 questions related to experiencing (micro)stressors which are rated on a 4-point scale, ranging from 0 (Did not happen/Almost never) to 3 ((Nearly) every day). Higher scores indicated a frequent experience of (micro)stressors.
Time frame
Baseline (week 1), 1-week post intervention (week 7) and 3 months follow-up (week 18)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
VU University of Amsterdam
Lead sponsor
World Health Organization
Collaborator
University of Copenhagen
Collaborator
University Hospital Heidelberg
Collaborator
Source ClinicalTrials.gov