NCT06989398

Brief Summary

This cluster randomized controlled trial (cRCT) aims to evaluate the effectiveness 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:

  • Assess to what extent the novel, WHO-developed ASCEND intervention is effective in enhancing supervisors' confidence, responsiveness, mental health literacy, and SelfCare 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 in the context of Dutch SMEs. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress76%
May 2025Sep 2026

First Submitted

Initial submission to the registry

May 6, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

May 14, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 25, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

November 19, 2025

Status Verified

May 1, 2025

Enrollment Period

1.3 years

First QC Date

May 6, 2025

Last Update Submit

November 18, 2025

Conditions

Keywords

Workplace mental healthOccupational stressSickness absenceSupervisorsLine managersAbsenteeismPresenteeismEmployee well-beingWorkplace interventionManager trainingASCENDAdvancing Supervisors' Capacity for Mental Health at Work

Outcome Measures

Primary Outcomes (1)

  • Supervisor confidence in supporting employees with mental health conditions

    Confidence in supporting employees with mental health conditions 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.

    Change from baseline to 1-hour post-intervention, 1 month, and 3 months

Secondary Outcomes (6)

  • Supervisor responsiveness to employee mental health conditions

    Change from baseline to 1 month and 3 months

  • Supervisor stigma towards mental health conditions

    Change from baseline to 1-hour post-intervention, 1 month, and 3 months

  • Supervisor SelfCare

    Change from baseline to 1 month and 3 months

  • Supervisor mental health literacy

    Change from baseline to 1-hour post-intervention and 1 month

  • Implementation indicator: acceptability

    1-hour post-intervention

  • +1 more secondary outcomes

Other Outcomes (8)

  • Perceived supervisor responsiveness to mental health conditions

    Change from baseline to 1 month and 3 months

  • Perceived StaffCare

    Change from baseline to 1 month and 3 months

  • Supervisee psychological distress

    Change from baseline to 1 month and 3 months

  • +5 more other outcomes

Study Arms (2)

Advancing Supervisors' Capacity for Mental Health at Work (ASCEND)

EXPERIMENTAL

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.

Behavioral: Advancing Supervisors' Capacity for Mental Health at Work (ASCEND)

Waitlist

NO INTERVENTION

Supervisors from organizations in the waitlist arm will receive no training during the trial. They will be provided with the ASCEND training approx. 6 months after baseline, after the last follow-up.

Interventions

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 and skill application, 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.

Also known as: Toolkit Mental Health for Supervisors, Toolkit Mentale Gezondheid voor Leidinggevenden
Advancing Supervisors' Capacity for Mental Health at Work (ASCEND)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vrije Universiteit Amsterdam

Amsterdam, 1081BT, Netherlands

RECRUITING

Related Links

MeSH Terms

Conditions

Burnout, PsychologicalOccupational Stress

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehaviorOccupational Diseases

Study Officials

  • Mark van Vugt, PhD

    VU University of Amsterdam

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amber S Brizar, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
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. 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) Waitlist (n=37), with an equal probability of assignment to each group (allocation ratio 1:1).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

May 6, 2025

First Posted

May 25, 2025

Study Start

May 14, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

November 19, 2025

Record last verified: 2025-05

Locations