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Leading Well-being and the Psychosocial Working Environment - A Cluster-randomized Waitlist Controlled Trial

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05623371
Acronym
Matterhorn
Enrollment
160
Registered
2022-11-21
Start date
2022-05-15
Completion date
2024-01-25
Last updated
2026-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burn Out, Stress, Well-being

Keywords

Manager training, stress, well-being, the psychosocial working environment

Brief 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. 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

Interventions

BEHAVIORALTraining leaders in leading well-being and the psychosocial working environment

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: 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.

BEHAVIORALThe offer of a webinar and written material

The offer of a webinar plus written material

Sponsors

University of Aarhus
Lead SponsorOTHER
Central Denmark Region
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

As the design is a waitlist controlled trial, the participants, the consultans and the some of the involved researchers will know what individuals received the intervention in 2023 (i.e. the treatment group), and 2024 (i.e. the control group).

Intervention model description

Cluster, randomized waitlist controlled trial. The treatment group receives the intervention in 2023, and the control group receives it in 2024.

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change in perceived selfcare in middle managers and employeesBaseline, post training (6 months follow-up) and 12 months follow-upMeasured 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 employeesBaseline, post training (6 months follow-up) and 12 months follow-upMeasured 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 employeesBaseline, post training (6 months follow-up) and 12 months follow-upMeasured 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 employeesBaseline, post training (6 months follow-up) and 12 months follow-upMeasured 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 employees12 monthsMeasured 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 employeesBaseline, post training (6 months follow-up) and 12 months follow-upMeasured 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)

Secondary

MeasureTime frameDescription
Change in central aspects of the psychosocial work environment among employees in employeesBaseline, post training (6 months follow-up) and 12 months follow-upMeasured 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)
Change in turnover intention among middle managers and employeesBaseline, post training (6 months follow-up) and 12 months follow-upMeasured with a self-formulated single-item
Change in perceived confidence among middle managersBaseline, post training (6 months follow-up) and 12 months follow-upModified 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)
Actual turnover among employees12 monthsMeasured with registered sickness absence from the business Intelligence department at the Central Denmark Region administration of sick-leave
Psychological saftetyBaseline, post training (6 months follow-up) and 12 months follow-upMeasured 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
Psychosocial safety climate among employeesBaseline, post training (6 months follow-up) and 12 months follow-upMeasured 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)
Change in Well-being among middle managers and employeesBaseline, post training (6 months follow-up) and 12 months follow-upMeasured 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
Change in the perceived psychosocial working environment in middle managers and employeesBaseline, post training (6 months follow-up) and 12 months follow-upMeasured 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)
Change in perceive leadership quality among employeesBaseline, post training (6 months follow-up) and 12 months follow-upMeasured 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)

Countries

Denmark

Contacts

PRINCIPAL_INVESTIGATORVita LP Dalgaard, Ph.D

Aarhus BSS, Aarhus University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 3, 2026