Occupational HealthNCT06989398
Implementation of the ASCEND Training for Supervisors in Dutch Small and Medium-sized Enterprises (SMEs)
A study testing Advancing Supervisors' Capacity for Mental Health at Work (ASCEND) in people with Occupational Health and Stress, run by VU University of Amsterdam at 1 site in Netherlands.
Trial summary
This cluster randomized controlled trial (cRCT) aims to evaluate the effectiveness of the Dutch adaptation of an in-person group intervention for workplace supervisors - Advancing Supervisors' Capacity for Mental Health at Work (ASCEND) - in Dutch Small and Medium-sized Enterprises (SMEs). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Occupational Health, Stress, Burnout
- What is being tested?
- Advancing Supervisors' Capacity for Mental Health at Work (ASCEND)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteNetherlands
- Study dates
- 14 May 2025to Feb 2027
- Phase
- Interventional
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
- Healthy volunteers accepted
- 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 with 10 to 250 employees, and units of larger organizations employing between 10 and 250 employees
- Eligibility criteria for individual participants:
- Supervisors are included if they fit the following inclusion criteria:
- 18 years or older
Show all 15Show fewer
- Working in an organization in the Netherlands
- Sufficient mastery (written and spoken) of the language in which the ASCEND intervention is being delivered (i.e., Dutch or English)
- Written informed consent before entering the study
- Supervise at least 1 supervisee within the same organization
- Supervisees are included if they fit the following inclusion criteria:
- 18 years or older
- Have a direct supervisor who is participating in ASCEND (either intervention or control group)
- Sufficient mastery of English or Dutch
- Written informed consent before entering the study
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Vrije Universiteit Amsterdam
Amsterdam, 1081BT
Amber S Brizar, MSc, +31 20 59 82587, a.s.brizar@vu.nl
Mark van Vugt, PhD
About this study
Official title: Cluster RCT of the WHO's Advancing Supervisor Capabilities for Mental Health at Work (ASCEND) in Dutch Small and Medium-sized Enterprises (SMEs)
This cluster randomized controlled trial (cRCT) aims to evaluate the effectiveness of the Dutch adaptation of an in-person group intervention for workplace supervisors - Advancing Supervisors' Capacity for Mental Health at Work (ASCEND) - in Dutch Small and Medium-sized Enterprises (SMEs). The ASCEND intervention is designed to equip supervisors with the skills to: i) know when to support their workers; ii) how to direct workers to support, and iii) advocate for action on mental health at work.
The primary objectives of this project are to:
Read more
- Assess to what extent the Dutch adaptation of the WHO-developed ASCEND intervention is effective in enhancing supervisors' confidence, responsiveness, mental health literacy, and self-care practices, and in reducing supervisor stigma towards mental health conditions within Dutch SMEs.
- Evaluate the impact of the ASCEND intervention on employee outcomes, including mental health and work-related outcomes among supervisees (i.e., subordinates), as well as overall organizational absenteeism rates.
- Identify barriers, facilitators, and key implementation and adoption indicators to support future opportunities for scaling up the ASCEND intervention.
Researchers will compare two groups to evaluate the effectiveness of the ASCEND intervention. One group will receive the training (the intervention group), while the other group will receive the training after the final follow-up period (the control group).
Data will be collected from both supervisors and their supervisees (i.e., subordinates) via online questionnaires at various time points. In addition, general organizational information, including absenteeism rates, will be gathered through a representative from each participating organization.
To further explore the feasibility of scaling up the ASCEND intervention within the Netherlands, qualitative data will be collected through interviews and/or focus group discussions.
Read the detailed description
Small and Medium-sized enterprises (SMEs) often lack the resources to effectively address the negative consequences of work-related stressors (e.g., high workplace digitalization). Moreover, supervisors play a pivotal role in protecting employee well-being, yet they frequently report feeling poorly equipped to recognize and support employees experiencing mental health problems.
This project aims to evaluate the effectiveness of the Dutch adaptation of Advancing Supervisors' Capacity for Mental Health at Work (ASCEND), an in-person group intervention developed by the World Health Organization (WHO). The ASCEND intervention is designed to equip supervisors with the skills to: i) know when to support their workers; ii) how to direct workers to support, and iii) advocate for action on mental health at work.
The first phase of this study concerns a cluster randomized controlled trial (cRCT) comparing ASCEND and control, where supervisors in the control group receive the intervention approx. 6 months after baseline. The second phase consists in the qualitative process evaluation that pertains individual interviews and/or focus group discussions.
In the first study phase, data will be collected through online questionnaires administered to supervisors and their supervisees (i.e., subordinates). Additionally, general organizational information, including absenteeism rates, will be gathered from a designated representative within each organization. Supervisors will complete surveys at baseline, immediately post-intervention, and at 1-month and 3-month follow-ups. Supervisees will complete surveys at baseline, 1-month follow-up, and 3-month follow-up.
The primary outcome is supervisor confidence in addressing employee mental health problems at the 1-month follow-up. Secondary outcomes include supervisor responsiveness, stigma toward mental health conditions, mental health literacy, and self-care practices. Supervisees will be invited to provide exploratory outcome data on perceived supervisor responsiveness, perceived supervisor staff care, psychological distress, help-seeking intentions, work stress, absenteeism, and presenteeism. Additionally, general absenteeism figures for the participating SMEs will be collected.
The study aims to recruit 74 SMEs, randomly allocated to either the ASCEND intervention group (n = 37) or the control group (n = 37). Each SME is expected to enrol at least two supervisors, resulting in a total sample of 148 managers for this study phase. Sample size calculations indicate that a minimum of 60 SMEs is required to detect a significant increase in supervisor confidence at 1-month follow-up with an effect size of Cohen's d = 0.59, accounting for 20% attrition (power = 0.80, two-sided alpha = 0.05, ICC = 0.01).
In the second study phase, a process evaluation will be conducted to assess factors such as intervention acceptability, appropriateness, barriers, and facilitators to implementation. Qualitative data will be gathered through post-intervention online surveys and interviews with a sample of supervisors, as well as relevant other stakeholders. In addition, we will collect process data to inform the implementation of the intervention.
This study is part of the larger EU H2022-ADVANCE project, which aims to improve the mental health of vulnerable populations in Europe.
- Conditions
- Occupational Health, Stress, Burnout, Mental Health Conditions, Sickness Absence
- Being tested
- Advancing Supervisors' Capacity for Mental Health at Work (ASCEND)
- Keywords
- Workplace mental health, Occupational stress, Sickness absence, Supervisors, Line managers, Absenteeism, Presenteeism, Employee well-being, Workplace intervention, Manager training, ASCEND, Advancing Supervisors' Capacity for Mental Health at Work
- Medical subject headings
- Burnout, Psychological, Occupational Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advancing Supervisors' Capacity for Mental Health at Work (ASCEND)Behavioural
Also called Toolkit Mental Health for Supervisors, Toolkit Mentale Gezondheid voor Leidinggevenden
The intervention will consist of a training that incorporates evidence-based content and interactive exercises. Advancing Supervisors' Capacity for Mental Health at Work (ASCEND) covers five core topics designed to equip supervisors with the knowledge and practical skills needed to effectively support the mental health of their employees. The full training is delivered over approximately 8 hours in an in-person group setting. Trainings are facilitated by a trained professional.
To support learning, participants will also receive a Manager Reference Booklet during the training. This booklet consolidates key information from the ASCEND training, serving both as a learning aid during the sessions and a practical, quick-reference tool afterward. It includes summaries of key concepts, tips, and exercises, along with space for participants to record notes. Participants receive a certificate for their participation in the training.
| Study group | Role | What they receive |
|---|---|---|
| Advancing Supervisors' Capacity for Mental Health at Work (ASCEND) | Experimental | Participants in the treatment group will receive the Dutch adaptation of the ASCEND group intervention, delivered in person over approximately 8 hours in a single day. Participants will be permitted to participate in other programs or training courses after enrolling in the trial. Receives: Behavioral: Advancing Supervisors' Capacity for Mental Health at Work (ASCEND) |
| Control | No intervention | Supervisors from organizations in the control arm will receive no ASCEND training during the trial. They will be provided with the ASCEND training approx. 6 months after baseline, after the last follow-up. Participants will be permitted to participate in other programs or training courses after enrolling in the trial. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Supervisor confidence in addressing employee mental health problems
Confidence in addressing employee mental health problems will be measured among supervisors using a 6-item scale used in other trials that investigated a similar intervention. Participants will be asked to rate their degree of confidence from 1 (not confident at all) to 5 (extremely confident) for various activities that are related to the construct of supporting employee mental health. A mean score will be calculated by averaging participants' ratings across all items. Scores range from 1 to 5, with a higher score indicating more confidence.
Measured: Change from baseline to 1 month
Secondary outcomes (5)
Supervisor confidence in addressing employee mental health problems
Confidence in addressing employee mental health problems will be measured among supervisors using a 6-item scale used in other trials that investigated a similar intervention. Participants will be asked to rate their degree of confidence from 1 (not confident at all) to 5 (extremely confident) for various activities that are related to the construct of supporting employee mental health. A mean score will be calculated by averaging participants' ratings across all items. Scores range from 1 to 5, with a higher score indicating more confidence.
Measured: Change from baseline to within 1-hour post-intervention and 3 months
Supervisor responsiveness to employee mental health problems
Responsiveness to mental health problems will be measured among supervisors using a 6-item scale used in earlier trials investigating a similar intervention. Participants rate each item on a 5-point Likert scale with 1 (strongly disagree) to 5 (strongly agree) to what extent they agree with the statement. A mean score will be calculated by averaging participants' ratings across all items. Scores range from 1 to 5, with a higher score indicating a better responsiveness.
Measured: Change from baseline to 1 month and 3 months
Supervisor stigma towards mental health conditions
Stigma towards mental health conditions will be measured among supervisors using the 12-item Stigma Toward Employee Depression Scale. Items are adjusted to fit a broader range of mental health conditions, instead of depression only. Participants rate each item on a 5-point Likert scale with 1 (strongly disagree) to 5 (strongly agree) to what extent they agree with the statement. A mean score will be calculated by averaging participants' ratings across all items. Scores range from 1 to 5, with a higher score indicating more stigma.
Measured: Change from baseline to 1-hour post-intervention, 1 month, and 3 months
Supervisor self-care
Self-care will be measured among supervisors using a construct originating from the Health-oriented Leadership framework. The full SelfCare scale consists of 3 subscales (i.e., awareness, values, and behavior), but this trial focuses only on the behaviors. From the behavior items, 3 items are chosen. Participants rate each item on a 5-point Likert scale with 1 (strongly disagree) to 5 (strongly agree) to what extent they agree with the statement. A mean score will be calculated by averaging participants' ratings across all items. Scores range from 1 to 5, with a higher score indicating better SelfCare.
Measured: Change from baseline to 1 month and 3 months
Supervisor mental health literacy
Mental health literacy will be measured among supervisors using vignette-based questions, based on vignettes from the Mental Health Literacy (MHL) scale. Supervisors will respond to open-ended questions about how they would handle each of the workplace scenarios described in the vignettes. Responses will be scored at a later stage. Each vignette-question will receive a score from 0 to 2, with higher scores reflecting higher mental health literacy.
Measured: Change from baseline to 1-hour post-intervention and 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start14 May 2025
- Primary completionDec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occupational HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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. The SMEs will be randomized using limited block size that varies randomly (i.e., 4, 6, or 8 SMEs per block) across (1) ASCEND (n=37) or (2) control (n=37), with an equal probability of assignment to each group (allocation ratio 1:1).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VU University of Amsterdam
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization, University of Copenhagen, University Hospital Heidelberg
- Responsible party
- Principal investigator, Mark van Vugt, VU University of Amsterdam
- Investigators
- Mark van Vugt, PhD, Principal investigator, VU University of Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06989398
- Sponsor's protocol ID
- 2024.0846
- Other IDs
- ADVANCE
- Status last verified
- Jul 2026
- First submitted
- 6 May 2025
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided