StressMatterhornNCT05623371
Leading Well-being and the Psychosocial Working Environment - A Cluster-randomized Waitlist Controlled Trial
A study testing Training leaders in leading well-being and the psychosocial working environment and The offer of a webinar and written material in people with Stress and Well-being, run by University of Aarhus at 1 site in Denmark.
Trial summary
The design comprises a cluster, randomized waitlist controlled design. The goal of the study is to prevent stress and burnout in middle managers and employees in a hospital setting. The study population is middle managers in a hospital setting. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Stress, Well-being, Burn Out
- What is being tested?
- Training leaders in leading well-being and the psychosocial working environment and The offer of a webinar and written material
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteDenmark
- Study dates
- 15 May 2022to 25 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Included managers are middle managers in hospitals in the Danish Central Region
- Included managers must be directly responsible for employees
- Included managers must be responsible for yearly assesment talks
Who cannot join
- If the above is not true, based on the data collected when the manager signed up for the study, the manager is not included in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Leading Well-being and the Psychosocial Working Environment - A Cluster-randomized Waitlist Controlled Trial of a Training Program for Middle Managers in a Danish Healthcare Setting
The design comprises a cluster, randomized waitlist controlled design. The goal of the study is to prevent stress and burnout in middle managers and employees in a hospital setting. The study population is middle managers in a hospital setting.
The intervention comprises five training modules with practice in small groups in between. Training will take place over 5 months. The training will be received in groups of 20 middle managers and the training will be facilitated by 2 facilitators. Themes of training are inspired by the concept of Health Oriented Leadership which takes into account that the well-being of managers is important for the well-being of employees. Central themes of the training are: 1) Self-care and well-being of the manager and how to cope with stress as a manager. 2) Employee well-being and reducing risk-factors in the psychosocial working environment of employee mental health problems. 3) Enhancing protective factors social social support and a healthy team climate. 4) Responding to employees at risk and how to handle difficult conversations and procedures on return to work. 5) Managing well-being in employees during changes and pressure.
Read more
In order to establish commitment for the waitlist control group, the control group will receive an offer of a webinar and some written information.
Middle managers in both intervention arms will receive a questionnaire at baseline, after the intervention and at 6 months follow-up. The intervention group will also receive a short questionnaire after each training.
The following expectations are hypothesized:
The training will improve self-care and perceived staff-care in middle managers and employees in the intervention group when compared to the control group
The training will improve psychological outcomes of stress, well-being, exhaustion and psychological symptoms among middle managers and employees in the intervention group when compared to the control group
The training will improve the perceived psychosocial working environment (PSWE) among middle managers and employees in the intervention group when compared to the control group
The training will reduce sickness absence and retention among middle managers and employees in the intervention group when compared to the control group
Middle managers who adhere more to the training will experience larger improvements in self-care, staff-care and mental outcomes
Read the detailed description
The design comprises a two-armed cluster, randomized waitlist controlled design. The goal of the study is to prevent stress and burnout in middle managers and employees in a hospital setting. The study population is middle managers in a hospital setting. These managers are randomized by unit and stratified on number of managers enrolled from each unit to obtain equal numbers in each arm.
The intervention comprises five training modules with practice in small groups in between. Training will take place over 5 months. The training will be received in groups of 20 middle managers and the training will be facilitated by 2 facilitators. Themes of training are inspired by the concept of Health Oriented Leadership which takes into account that the well-being of middle managers is important for the well-being of employees. Central themes of the training are: 1) Self-care and well-being of the manager and how to cope with stress as a manager. 2) Employee well-being and reducing risk-factors in the psychosocial working environment of employee mental health problems. 3) Enhancing protective factors social social support and a healthy team climate. 4) Responding to employees at risk and how to handle difficult conversations and procedures on return to work. 5) Managing well-being in employees during changes and pressure.
In order to establish commitment for the waitlist control group, the control group will receive an offer of a webinar and some written information.
Middle managers in both intervention arms will receive a questionnaire at baseline, after the intervention and at 6 months follow-up. The intervention group will also receive a short questionnaire after each training.
The following expectations are hypothesized:
The training will improve self-care and perceived staff-care in middle managers and in employees in the intervention group when compared to the control group
The training will improve psychological outcomes of stress, well-being, exhaustion and psychological symptoms among middle managers and employees in the intervention group when compared to the control group
The training will improve the perceived psychosocial working environment (PSWE) among middle managers and employees in the intervention group when compared to the control group
The training will reduce sickness absence and retention among middle managers and employees in the intervention group when compared to the control group
Middle managers who adhere more to the training will experience larger improvements in self-care, staff-care and mental outcomes
- Conditions
- Stress, Well-being, Burn Out
- Being tested
- Training leaders in leading well-being and the psychosocial working environment, The offer of a webinar and written material
- Keywords
- Manager training, stress, well-being, the psychosocial working environment
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training leaders in leading well-being and the psychosocial working environmentBehavioural
The intervention comprises five training modules with practice in small groups in between. Training will take place over 5 months. The training will be received in groups of 20 and the training will be facilitated by 2 facilitators. Central themes of the training are:
- Self-care and well-being of the manager and how to cope with stress as a manager.
- Employee well-being and reducing risk-factors in the psychosocial working environment of employee mental health problems
- Enhancing protective factors social social support and a healthy team climate
- Responding to employees at risk and how to handle difficult conversations and procedures on return to work
- Managing well-being in employees during organizational change and final reflections
The training will comprise video material and in person training of competencies and behaviors in group settings.
The waitlist control group will receive an offer of a webinar and written information.
The offer of a webinar and written materialBehavioural
The offer of a webinar plus written material
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Leadership training comprising 5 modules and group exercises Receives: Behavioral: Training leaders in leading well-being and the psychosocial working environment |
| Control group | Other | Active control group receiving the offer of a webinar and written material Receives: Behavioral: The offer of a webinar and written material |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in perceived selfcare in middle managers and employees
Measured with 16 items using an adapted version of the selfcare scale from The Health-Oriented Leadership questionnaire (Franke et al. 2014). Items are scored using a 5 point Likert scale ranging from 1 (a very low degree) to 5 (a very high degree) indicating to which extent they practice selfcare in relation to their work life
Measured: Baseline, post training (6 months follow-up) and 12 months follow-up
Change in perceived Staffcare in middle managers and employees
Measured with 18 items using an adapted version of the staffcare scale from The Health-Oriented Leadership questionnaire (Franke et al. 2014). Items are scored using a 5 point Likert scale ranging from 1 (a very low degree) to 5 (a very high degree) indicating to which extent they practice selfcare in relation to their work life.
Measured: Baseline, post training (6 months follow-up) and 12 months follow-up
Change in perceived stress in middle managers and employees
Measured with the Danish consensus version of the Perceived Stress Scale 10 (Eskildsen et al. 2015). The scale comprises 10 items measured on a five point likert scale ranging from 0 (never) to 4 (very ofte). A higher score indicates higher stress levels.
Measured: Baseline, post training (6 months follow-up) and 12 months follow-up
Change in burnout in middle managers and employees
Measured with the Copenhagen Burnout Inventory. 19 Items are answered on a 6-point likert scale ranging from 0 (never) to 5 (always). The CBI understands the core components of burnout as fatigue and exhaustion.
Measured: Baseline, post training (6 months follow-up) and 12 months follow-up
Registered sickness absence in middle managers and employees
Measured with registered sickness absence from the business Intelligence department at the Central Denmark Region administration of sick-leave
Measured: 12 months
Change in job satisfaction in middle managers and employees
Measured with the Danish Psychosocial Questionnaire (Clausen et al. 2019), the job satisfaction item is scored on scale ranging from 0 (very unsatisfied) to 10 (very satisfied)
Measured: Baseline, post training (6 months follow-up) and 12 months follow-up
Secondary outcomes (9)
Change in Well-being among middle managers and employees
Measured with the WHO-5 well-being index (Bech et al. 2003). Items are answered on a 6 point Likert scale from 0 (at no time point) till 5 (all the time). The scale ranges from 0-100 where a higher score indicates higher well-being
Measured: Baseline, post training (6 months follow-up) and 12 months follow-up
Change in the perceived psychosocial working environment in middle managers and employees
Measured with one item from the Danish Psychosocial Questionnaire (Clausen et al 2019).The job satisfaction item is scored on scale ranging from 0 (very unsatisfied) to 10 (very satisfied)
Measured: Baseline, post training (6 months follow-up) and 12 months follow-up
Change in perceive leadership quality among employees
Measured with four items from the Danish Psychosocial Questionnaire (Clausen et al 2019). Items were scored on a 5 point Likert scale ranging from 1 (to a very high extent) to 5 (to a very low extent)
Measured: Baseline, post training (6 months follow-up) and 12 months follow-up
Change in central aspects of the psychosocial work environment among employees in employees
Measured with the Danish Psychosocial Questionnaire (Clausen et al 2019). Addresses areas as influence, recognition, possibilities to conduct work tasks, predictability, recognition, social support from manager and colleagues quantitative and emotional demands, justice, work-life balance.
Items are scored on a 5 point Likert scale ranging from 1 (to a very high extent) to 5 (to a very low extent)
Measured: Baseline, post training (6 months follow-up) and 12 months follow-up
Change in turnover intention among middle managers and employees
Measured with a self-formulated single-item
Measured: Baseline, post training (6 months follow-up) and 12 months follow-up
Actual turnover among employees
Measured with registered sickness absence from the business Intelligence department at the Central Denmark Region administration of sick-leave
Measured: 12 months
Change in perceived confidence among middle managers
Modified version of items used in A New Online Mental Health Training Program for Workplace Managers: Pre-Post Pilot Study Assessing Feasibility, Usability, and Possible Effectiveness by Gayed et al. 2018
Items were scored on a 5 point Likert scale ranging from 1 (to a very low degree) to 5 (to a very high degree)
Measured: Baseline, post training (6 months follow-up) and 12 months follow-up
Psychological saftety
Measured five items from with scale by Edmonson 2018 items were scored on a scale from 1 (completely disagree) to 5 (completely agree) A higher score indicate a higher level of psychological safety
Measured: Baseline, post training (6 months follow-up) and 12 months follow-up
Psychosocial safety climate among employees
Measured six items using an adapted version of the Psychosocial Safety Climate measure (PSC-12) items were scored on a scale from 1 (completely disagree) to 5 (completely agree)
Measured: Baseline, post training (6 months follow-up) and 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start15 May 2022
- Primary completion25 Jan 2024
- Study completion25 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Cluster, randomized waitlist controlled trial. The treatment group receives the intervention in 2023, and the control group receives it in 2024.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Central Denmark Region
- Responsible party
- Sponsor
- Investigators
- Vita LP Dalgaard, Ph.D, Principal investigator, Aarhus BSS, Aarhus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05623371
- Sponsor's protocol ID
- Matterhorn
- Acronym
- Matterhorn
- Status last verified
- Jun 2026
- First submitted
- 12 Oct 2022
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to data security regulation is it not possible to make individual participant data available to other researchers outside Aarhus University
Publications
Andersen LL, Thorsen SV, Larsen M, Sundstrup E, Boot CR, Rugulies R. Work factors facilitating working beyond state pension age: Prospective cohort study with register follow-up. Scand J Work Environ Health. 2021 Jan 1;47(1):15-21. doi: 10.5271/sjweh.3904. Epub 2020 May 28.
PubMed 32463101Skakon J, Nielsen K, Borg V, Guzman J. Are leaders' well-being behaviours and style associated with the affective well-being of employees? A systematic review of three decades of research. Work and Stress - WORK STRESS. 2010;24:107-39.
Petrie K, Gayed A, Bryan BT, Deady M, Madan I, Savic A, Wooldridge Z, Counson I, Calvo RA, Glozier N, Harvey SB. The importance of manager support for the mental health and well-being of ambulance personnel. PLoS One. 2018 May 23;13(5):e0197802. doi: 10.1371/journal.pone.0197802. eCollection 2018.
PubMed 29791510Harms PD, Credé M, Tynan M, Leon M, Jeung W. Leadership and stress: A meta-analytic review. The Leadership Quarterly. 2017;28(1):178-94
Gayed A, Milligan-Saville JS, Nicholas J, Bryan BT, LaMontagne AD, Milner A, Madan I, Calvo RA, Christensen H, Mykletun A, Glozier N, Harvey SB. Effectiveness of training workplace managers to understand and support the mental health needs of employees: a systematic review and meta-analysis. Occup Environ Med. 2018 Jun;75(6):462-470. doi: 10.1136/oemed-2017-104789. Epub 2018 Mar 21.
PubMed 29563195Milligan-Saville JS, Tan L, Gayed A, Barnes C, Madan I, Dobson M, Bryant RA, Christensen H, Mykletun A, Harvey SB. Workplace mental health training for managers and its effect on sick leave in employees: a cluster randomised controlled trial. Lancet Psychiatry. 2017 Nov;4(11):850-858. doi: 10.1016/S2215-0366(17)30372-3. Epub 2017 Oct 12.
PubMed 29031935Taris TW, Nielsen K. Leadership in occupational health psychology. Work & Stress. 2019;33(2):105-6.
Rugulies R. What is a psychosocial work environment? Scand J Work Environ Health. 2019 Jan 1;45(1):1-6. doi: 10.5271/sjweh.3792. No abstract available.
PubMed 30643919Harvey SB, Modini M, Joyce S, Milligan-Saville JS, Tan L, Mykletun A, Bryant RA, Christensen H, Mitchell PB. Can work make you mentally ill? A systematic meta-review of work-related risk factors for common mental health problems. Occup Environ Med. 2017 Mar;74(4):301-310. doi: 10.1136/oemed-2016-104015. Epub 2017 Jan 20.
PubMed 28108676Nieuwenhuijsen K, Verbeek JH, de Boer AG, Blonk RW, van Dijk FJ. Supervisory behaviour as a predictor of return to work in employees absent from work due to mental health problems. Occup Environ Med. 2004 Oct;61(10):817-23. doi: 10.1136/oem.2003.009688.
PubMed 15377767Ladegaard Y, Skakon J, Elrond AF, Netterstrom B. How do line managers experience and handle the return to work of employees on sick leave due to work-related stress? A one-year follow-up study. Disabil Rehabil. 2019 Jan;41(1):44-52. doi: 10.1080/09638288.2017.1370733. Epub 2017 Aug 28.
PubMed 28845715Bryan BT, Gayed A, Milligan-Saville JS, Madan I, Calvo RA, Glozier N, Harvey SB. Managers' response to mental health issues among their staff. Occup Med (Lond). 2018 Sep 13;68(7):464-468. doi: 10.1093/occmed/kqy103.
PubMed 30060150Tafvelin S, Hasson H, Nielsen K, Von Thiele Schwarz U. Integrating a transfer perspective into evaluations of leadership training. Leadership and Organization Development Journal. 2021;ahead-of-print.
von Thiele Schwarz U, Nielsen K, Edwards K, Hasson H, Ipsen C, Savage C, Simonsen Abildgaard J, Richter A, Lornudd C, Mazzocato P, Reed JE. How to design, implement and evaluate organizational interventions for maximum impact: the Sigtuna Principles. Eur J Work Organ Psychol. 2020 Aug 26;30(3):415-427. doi: 10.1080/1359432X.2020.1803960. eCollection 2021.
PubMed 34518756Lacerenza CN, Reyes DL, Marlow SL, Joseph DL, Salas E. Leadership training design, delivery, and implementation: A meta-analysis. J Appl Psychol. 2017 Dec;102(12):1686-1718. doi: 10.1037/apl0000241. Epub 2017 Jul 27.
PubMed 28749153
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leading Well-being and the Psychosocial Working Environment - A Cluster-randomized Waitlist Controlled Trial of a Training Program for Middle Managers in a Danish Healthcare Setting
- ClinicalTrials.gov ID
- NCT05623371
- Acronym / sponsor ID
- Matterhorn / Matterhorn
- Conditions
- Stress, Well-being, Burn Out
- Keywords
- Manager training, stress, well-being, the psychosocial working environment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Central Denmark Region
- Study start
- 15 May 2022 (actual)
- Primary completion
- 25 Jan 2024 (actual)
- Study completion
- 25 Jan 2024 (actual)
- First posted
- 21 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The design comprises a cluster, randomized waitlist controlled design. The goal of the study is to prevent stress and burnout in middle managers and employees in a hospital setting. The study population is middle managers in a hospital setting.
The intervention comprises five training modules with practice in small groups in between. Training will take place over 5 months. The training will be received in groups of 20 middle managers and the training will be facilitated by 2 facilitators. Themes of training are inspired by the concept of Health Oriented Leadership which takes into account that the well-being of managers is important for the well-being of employees. Central themes of the training are: 1) Self-care and well-being of the manager and how to cope with stress as a manager. 2) Employee well-being and reducing risk-factors in the psychosocial working environment of employee mental health problems. 3) Enhancing protective factors social social support and a healthy team climate. 4) Responding to employees at risk and how to handle difficult conversations and procedures on return to work. 5) Managing well-being in employees during changes and pressure.
In order to establish commitment for the waitlist control group, the control group will receive an offer of a webinar and some written information.
Middle managers in both intervention arms will receive a questionnaire at baseline, after the intervention and at 6 months follow-up. The intervention group will also receive a short questionnaire after each training.
The following expectations are hypothesized:
The training will improve self-care and perceived staff-care in middle managers and employees in the intervention group when compared to the control group
The training will improve psychological outcomes of stress, well-being, exhaustion and psychological symptoms among middle managers and employees in the intervention group when compared to the control group
The training will improve the perceived psychosocial working environment (PSWE) among middle managers and employees in the intervention group when compared to the control group
The training will reduce sickness absence and retention among middle managers and employees in the intervention group when compared to the control group
Middle managers who adhere more to the training will experience larger improvements in self-care, staff-care and mental outcomes
Detailed description
The design comprises a two-armed cluster, randomized waitlist controlled design. The goal of the study is to prevent stress and burnout in middle managers and employees in a hospital setting. The study population is middle managers in a hospital setting. These managers are randomized by unit and stratified on number of managers enrolled from each unit to obtain equal numbers in each arm.
The intervention comprises five training modules with practice in small groups in between. Training will take place over 5 months. The training will be received in groups of 20 middle managers and the training will be facilitated by 2 facilitators. Themes of training are inspired by the concept of Health Oriented Leadership which takes into account that the well-being of middle managers is important for the well-being of employees. Central themes of the training are: 1) Self-care and well-being of the manager and how to cope with stress as a manager. 2) Employee well-being and reducing risk-factors in the psychosocial working environment of employee mental health problems. 3) Enhancing protective factors social social support and a healthy team climate. 4) Responding to employees at risk and how to handle difficult conversations and procedures on return to work. 5) Managing well-being in employees during changes and pressure.
In order to establish commitment for the waitlist control group, the control group will receive an offer of a webinar and some written information.
Middle managers in both intervention arms will receive a questionnaire at baseline, after the intervention and at 6 months follow-up. The intervention group will also receive a short questionnaire after each training.
The following expectations are hypothesized:
The training will improve self-care and perceived staff-care in middle managers and in employees in the intervention group when compared to the control group
The training will improve psychological outcomes of stress, well-being, exhaustion and psychological symptoms among middle managers and employees in the intervention group when compared to the control group
The training will improve the perceived psychosocial working environment (PSWE) among middle managers and employees in the intervention group when compared to the control group
The training will reduce sickness absence and retention among middle managers and employees in the intervention group when compared to the control group
Middle managers who adhere more to the training will experience larger improvements in self-care, staff-care and mental outcomes
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster, randomized waitlist controlled trial. The treatment group receives the intervention in 2023, and the control group receives it in 2024.
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Behavioral: Training leaders in leading well-being and the psychosocial working environmentLeadership training comprising 5 modules and group exercises |
| Control group | Other | Behavioral: The offer of a webinar and written materialActive control group receiving the offer of a webinar and written material |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Included managers are middle managers in hospitals in the Danish Central Region
- Included managers must be directly responsible for employees
- Included managers must be responsible for yearly assesment talks
Key exclusion criteria (1 listed)
- If the above is not true, based on the data collected when the manager signed up for the study, the manager is not included in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training leaders in leading well-being and the psychosocial working environmentThe intervention comprises five training modules with practice in small groups in between. Training will take place over 5 months. The training will be received in groups of 20 and the training will be facilitated by 2 facilitators. Central themes of the training are: 1. Self-care and well-being of the manager and how to cope with stress as a manager. 2. Employee well-being and reducing risk-factors in the psychosocial working environment of employee mental health problems 3. Enhancing protective factors social social support and a healthy team climate 4. Responding to employees at risk and how to handle difficult conversations and procedures on return to work 5. Managing well-being in employees during organizational change and final reflections The training will comprise video material and in person training of competencies and behaviors in group settings. The waitlist control group will receive an offer of a webinar and written information. | Behavioural | Treatment group |
| The offer of a webinar and written materialThe offer of a webinar plus written material | Behavioural | Control group |
Primary outcome
Change in perceived selfcare in middle managers and employees
Time frame: Baseline, post training (6 months follow-up) and 12 months follow-up
Measured with 16 items using an adapted version of the selfcare scale from The Health-Oriented Leadership questionnaire (Franke et al. 2014). Items are scored using a 5 point Likert scale ranging from 1 (a very low degree) to 5 (a very high degree) indicating to which extent they practice selfcare in relation to their work life
Change in perceived Staffcare in middle managers and employees
Time frame: Baseline, post training (6 months follow-up) and 12 months follow-up
Measured with 18 items using an adapted version of the staffcare scale from The Health-Oriented Leadership questionnaire (Franke et al. 2014). Items are scored using a 5 point Likert scale ranging from 1 (a very low degree) to 5 (a very high degree) indicating to which extent they practice selfcare in relation to their work life.
Change in perceived stress in middle managers and employees
Time frame: Baseline, post training (6 months follow-up) and 12 months follow-up
Measured with the Danish consensus version of the Perceived Stress Scale 10 (Eskildsen et al. 2015). The scale comprises 10 items measured on a five point likert scale ranging from 0 (never) to 4 (very ofte). A higher score indicates higher stress levels.
Change in burnout in middle managers and employees
Time frame: Baseline, post training (6 months follow-up) and 12 months follow-up
Measured with the Copenhagen Burnout Inventory. 19 Items are answered on a 6-point likert scale ranging from 0 (never) to 5 (always). The CBI understands the core components of burnout as fatigue and exhaustion.
Registered sickness absence in middle managers and employees
Time frame: 12 months
Measured with registered sickness absence from the business Intelligence department at the Central Denmark Region administration of sick-leave
Change in job satisfaction in middle managers and employees
Time frame: Baseline, post training (6 months follow-up) and 12 months follow-up
Measured with the Danish Psychosocial Questionnaire (Clausen et al. 2019), the job satisfaction item is scored on scale ranging from 0 (very unsatisfied) to 10 (very satisfied)
9 secondary outcomes
Change in Well-being among middle managers and employees
Time frame: Baseline, post training (6 months follow-up) and 12 months follow-up
Change in the perceived psychosocial working environment in middle managers and employees
Time frame: Baseline, post training (6 months follow-up) and 12 months follow-up
Change in perceive leadership quality among employees
Time frame: Baseline, post training (6 months follow-up) and 12 months follow-up
Change in central aspects of the psychosocial work environment among employees in employees
Time frame: Baseline, post training (6 months follow-up) and 12 months follow-up
Change in turnover intention among middle managers and employees
Time frame: Baseline, post training (6 months follow-up) and 12 months follow-up
Actual turnover among employees
Time frame: 12 months
Change in perceived confidence among middle managers
Time frame: Baseline, post training (6 months follow-up) and 12 months follow-up
Psychological saftety
Time frame: Baseline, post training (6 months follow-up) and 12 months follow-up
Psychosocial safety climate among employees
Time frame: Baseline, post training (6 months follow-up) and 12 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Background: PubMed 32463101Andersen LL, Thorsen SV, Larsen M, Sundstrup E, Boot CR, Rugulies R. Work factors facilitating working beyond state pension age: Prospective cohort study with register follow-up. Scand J Work Environ Health. 2021 Jan 1;47(1):15-21. doi: 10.5271/sjweh.3904. Epub 2020 May 28.
- BackgroundSkakon J, Nielsen K, Borg V, Guzman J. Are leaders' well-being behaviours and style associated with the affective well-being of employees? A systematic review of three decades of research. Work and Stress - WORK STRESS. 2010;24:107-39.
- Background: PubMed 29791510Petrie K, Gayed A, Bryan BT, Deady M, Madan I, Savic A, Wooldridge Z, Counson I, Calvo RA, Glozier N, Harvey SB. The importance of manager support for the mental health and well-being of ambulance personnel. PLoS One. 2018 May 23;13(5):e0197802. doi: 10.1371/journal.pone.0197802. eCollection 2018.
- BackgroundHarms PD, Credé M, Tynan M, Leon M, Jeung W. Leadership and stress: A meta-analytic review. The Leadership Quarterly. 2017;28(1):178-94
- Background: PubMed 29563195Gayed A, Milligan-Saville JS, Nicholas J, Bryan BT, LaMontagne AD, Milner A, Madan I, Calvo RA, Christensen H, Mykletun A, Glozier N, Harvey SB. Effectiveness of training workplace managers to understand and support the mental health needs of employees: a systematic review and meta-analysis. Occup Environ Med. 2018 Jun;75(6):462-470. doi: 10.1136/oemed-2017-104789. Epub 2018 Mar 21.
- Background: PubMed 29031935Milligan-Saville JS, Tan L, Gayed A, Barnes C, Madan I, Dobson M, Bryant RA, Christensen H, Mykletun A, Harvey SB. Workplace mental health training for managers and its effect on sick leave in employees: a cluster randomised controlled trial. Lancet Psychiatry. 2017 Nov;4(11):850-858. doi: 10.1016/S2215-0366(17)30372-3. Epub 2017 Oct 12.
- BackgroundTaris TW, Nielsen K. Leadership in occupational health psychology. Work & Stress. 2019;33(2):105-6.
- Background: PubMed 30643919Rugulies R. What is a psychosocial work environment? Scand J Work Environ Health. 2019 Jan 1;45(1):1-6. doi: 10.5271/sjweh.3792. No abstract available.
- Background: PubMed 28108676Harvey SB, Modini M, Joyce S, Milligan-Saville JS, Tan L, Mykletun A, Bryant RA, Christensen H, Mitchell PB. Can work make you mentally ill? A systematic meta-review of work-related risk factors for common mental health problems. Occup Environ Med. 2017 Mar;74(4):301-310. doi: 10.1136/oemed-2016-104015. Epub 2017 Jan 20.
- Background: PubMed 15377767Nieuwenhuijsen K, Verbeek JH, de Boer AG, Blonk RW, van Dijk FJ. Supervisory behaviour as a predictor of return to work in employees absent from work due to mental health problems. Occup Environ Med. 2004 Oct;61(10):817-23. doi: 10.1136/oem.2003.009688.
- Background: PubMed 28845715Ladegaard Y, Skakon J, Elrond AF, Netterstrom B. How do line managers experience and handle the return to work of employees on sick leave due to work-related stress? A one-year follow-up study. Disabil Rehabil. 2019 Jan;41(1):44-52. doi: 10.1080/09638288.2017.1370733. Epub 2017 Aug 28.
- Background: PubMed 30060150Bryan BT, Gayed A, Milligan-Saville JS, Madan I, Calvo RA, Glozier N, Harvey SB. Managers' response to mental health issues among their staff. Occup Med (Lond). 2018 Sep 13;68(7):464-468. doi: 10.1093/occmed/kqy103.
- Individual participant dataSharing planned: No. Due to data security regulation is it not possible to make individual participant data available to other researchers outside Aarhus University
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vita LP Dalgaard, Ph.D principal investigator
Aarhus BSS, Aarhus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training leaders in leading well-being and the psychosocial working environment and The offer of a webinar and written material in people with Stress and Well-being, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in perceived selfcare in middle managers and employees (time frame: Baseline, post training (6 months follow-up) and 12 months follow-up). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05623371, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.