Anxiety, Depression, Psychological Distress
Conditions
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
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 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.
Interventions
BEHAVIORALDoing 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).
Sponsors
VU University of Amsterdam
World Health Organization
University of Copenhagen
University Hospital Heidelberg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
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: 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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) | Change from Baseline (week 1) to 1-week post intervention (week 7) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) | Change from Baseline (week 1) to 3 months follow-up (week 18) | 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. |
| Patient Health Questionnaire (PHQ-9) | Change from Baseline (week 1) to 1-week post intervention (week 7) and 3 months follow-up (week 18) | 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. |
| 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) | 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. |
| Burnout Assessment Tool (BAT-4) | Change from Baseline (week 1) to 1-week post intervention (week 7) and 3 months follow-up (week 18) | 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. |
| Utrecht Work Engagement Scale (UWES-3) | Change from Baseline (week 1) to 1-week post intervention (week 7) and 3 months follow-up (week 18) | 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. |
| Ultra-Brief Self-Stigma of Seeking Help Scale (SSOSH-3) | Change from Baseline (week 1) to 1-week post intervention (week 7) and 3 months follow-up (week 18) | 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. |
| Absenteeism and Presenteeism | Change from Baseline (week 1) to 1-week post intervention (week 7) and 3 months follow-up (week 18) | 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? |
Countries
Netherlands
Contacts
CONTACTCătălin Gherdan
CONTACTAnke B. Witteveen
PRINCIPAL_INVESTIGATORMarit E. Sijbrandij
VU University of Amsterdam
Outcome results
None listed