NCT06989398

Brief 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). 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 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.

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
6mo 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
May 2025Feb 2027

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
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

July 21, 2026

Status Verified

July 1, 2026

Enrollment Period

1.6 years

First QC Date

May 6, 2025

Last Update Submit

July 17, 2026

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 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.

    Change from baseline to 1 month

Secondary Outcomes (5)

  • Supervisor confidence in addressing employee mental health problems

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

  • Supervisor responsiveness to employee mental health problems

    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 self-care

    Change from baseline to 1 month and 3 months

  • Supervisor mental health literacy

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

Other Outcomes (10)

  • Perceived supervisor responsiveness to mental health problems

    Change from baseline to 1 month and 3 months

  • Perceived supervisor staff care

    Change from baseline to 1 month and 3 months

  • Supervisee psychological distress

    Change from baseline to 1 month and 3 months

  • +7 more other outcomes

Study Arms (2)

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.

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.

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, 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.

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) control (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)

December 1, 2026

Study Completion (Estimated)

February 1, 2027

Last Updated

July 21, 2026

Record last verified: 2026-07

Locations