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Completed

NCT Number: NCT05623371

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

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

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Key information

Conditions

Stress Behavior Behavioral Symptoms Burn Out Burnout, Psychological Stress, Psychological Well-Being

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus Universitet

Aarhus, 8000, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Behavioral

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 material

Behavioral

The offer of a webinar plus written material

Primary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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)

Secondary outcomes

  1. Change in Well-being among middle managers and employees

    Time frame: Baseline, post training (6 months follow-up) and 12 months follow-up

    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

  2. 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

    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)

  3. Change in perceive leadership quality among employees

    Time frame: Baseline, post training (6 months follow-up) and 12 months follow-up

    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)

  4. 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

    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)

  5. Change in turnover intention among middle managers and employees

    Time frame: Baseline, post training (6 months follow-up) and 12 months follow-up

    Measured with a self-formulated single-item

  6. Actual turnover among employees

    Time frame: 12 months

    Measured with registered sickness absence from the business Intelligence department at the Central Denmark Region administration of sick-leave

  7. Change in perceived confidence among middle managers

    Time frame: Baseline, post training (6 months follow-up) and 12 months follow-up

    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)

  8. Psychological saftety

    Time frame: Baseline, post training (6 months follow-up) and 12 months follow-up

    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

  9. Psychosocial safety climate among employees

    Time frame: Baseline, post training (6 months follow-up) and 12 months follow-up

    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)

Other outcomes

  1. Questions on readiness among participating middle managers

    Time frame: 12 months

    Self-formulated process questions on readiness and adherence

  2. Compliance with training programme among participating middle managers

    Time frame: 6 months

    Measured with administrative data on attendance at each module of the training program

  3. Distress symptoms among middle managers and employees

    Time frame: 12 months

    Measured with Symptom Checklist, SCL-90-R

  4. Change in sleep quality among middle managers and employees

    Time frame: Baseline, post training (6 months follow-up) and 12 months follow-up

    Two items from the Karolinska Sleep Questionnaire. Items were answered on a 5 point Likert scale ranging 1 (bad) to extremely good (5)

  5. Change in knowledge on main topics among participating middle managers

    Time frame: Baseline, post training (6 months follow-up) and 12 months follow-up

    Self-formulated questions on degree of knowledge

  6. Change in attitudes towards managing well-being among participating middle managers

    Time frame: Baseline, post training (6 months follow-up) and 12 months follow-up

    Self-formulated questions on attitude

  7. Change in behavior aimed at managing well-being among participating middle managers

    Time frame: Baseline, post training (6 months follow-up) and 12 months follow-up

    Self-formulated questions on behavior

  8. Change in Perceived quality of patient care among employees

    Time frame: Baseline, post training (6 months follow-up) and 12 months follow-up

    Self-formulated questions on perceived quality of patient care

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Central Denmark Region

Registry information

Official study 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

Acronym: Matterhorn

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 21, 2022
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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