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

Primary Purpose

Stress, Well-being, Burn Out

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Training leaders in leading well-being and the psychosocial working environment
The offer of a webinar and written material
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stress focused on measuring Manager training, stress, well-being, the psychosocial working environment

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Aarhus UniversitetRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Treatment group

Control group

Arm Description

Leadership training comprising 5 modules and group exercises

Active control group receiving the offer of a webinar and written material

Outcomes

Primary Outcome Measures

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
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.
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.
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.
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
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)

Secondary Outcome Measures

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
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)
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)
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)
Change in turnover intention among middle managers and employees
Measured with a self-formulated single-item
Actual turnover among employees
Measured with registered sickness absence from the business Intelligence department at the Central Denmark Region administration of sick-leave
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)
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
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)

Full Information

First Posted
October 12, 2022
Last Updated
November 14, 2022
Sponsor
University of Aarhus
Collaborators
Central Denmark Region
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1. Study Identification

Unique Protocol Identification Number
NCT05623371
Brief Title
Leading Well-being and the Psychosocial Working Environment - A Cluster-randomized Waitlist Controlled Trial
Acronym
Matterhorn
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2022 (Actual)
Primary Completion Date
January 8, 2024 (Anticipated)
Study Completion Date
January 8, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Central Denmark Region

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Well-being, Burn Out
Keywords
Manager training, stress, well-being, the psychosocial working environment

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cluster, randomized waitlist controlled trial. The treatment group receives the intervention in 2023, and the control group receives it in 2024.
Masking
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).
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Leadership training comprising 5 modules and group exercises
Arm Title
Control group
Arm Type
Other
Arm Description
Active control group receiving the offer of a webinar and written material
Intervention Type
Behavioral
Intervention Name(s)
Training leaders in leading well-being and the psychosocial working environment
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
The offer of a webinar and written material
Intervention Description
The offer of a webinar plus written material
Primary Outcome Measure Information:
Title
Change in perceived selfcare in middle managers and employees
Description
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
Time Frame
Baseline, post training (6 months follow-up) and 12 months follow-up
Title
Change in perceived Staffcare in middle managers and employees
Description
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.
Time Frame
Baseline, post training (6 months follow-up) and 12 months follow-up
Title
Change in perceived stress in middle managers and employees
Description
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.
Time Frame
Baseline, post training (6 months follow-up) and 12 months follow-up
Title
Change in burnout in middle managers and employees
Description
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.
Time Frame
Baseline, post training (6 months follow-up) and 12 months follow-up
Title
Registered sickness absence in middle managers and employees
Description
Measured with registered sickness absence from the business Intelligence department at the Central Denmark Region administration of sick-leave
Time Frame
12 months
Title
Change in job satisfaction in middle managers and employees
Description
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)
Time Frame
Baseline, post training (6 months follow-up) and 12 months follow-up
Secondary Outcome Measure Information:
Title
Change in Well-being among middle managers and employees
Description
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
Time Frame
Baseline, post training (6 months follow-up) and 12 months follow-up
Title
Change in the perceived psychosocial working environment in middle managers and employees
Description
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)
Time Frame
Baseline, post training (6 months follow-up) and 12 months follow-up
Title
Change in perceive leadership quality among employees
Description
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)
Time Frame
Baseline, post training (6 months follow-up) and 12 months follow-up
Title
Change in central aspects of the psychosocial work environment among employees in employees
Description
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)
Time Frame
Baseline, post training (6 months follow-up) and 12 months follow-up
Title
Change in turnover intention among middle managers and employees
Description
Measured with a self-formulated single-item
Time Frame
Baseline, post training (6 months follow-up) and 12 months follow-up
Title
Actual turnover among employees
Description
Measured with registered sickness absence from the business Intelligence department at the Central Denmark Region administration of sick-leave
Time Frame
12 months
Title
Change in perceived confidence among middle managers
Description
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)
Time Frame
Baseline, post training (6 months follow-up) and 12 months follow-up
Title
Psychological saftety
Description
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
Time Frame
Baseline, post training (6 months follow-up) and 12 months follow-up
Title
Psychosocial safety climate among employees
Description
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)
Time Frame
Baseline, post training (6 months follow-up) and 12 months follow-up
Other Pre-specified Outcome Measures:
Title
Questions on readiness among participating middle managers
Description
Self-formulated process questions on readiness and adherence
Time Frame
12 months
Title
Compliance with training programme among participating middle managers
Description
Measured with administrative data on attendance at each module of the training program
Time Frame
6 months
Title
Distress symptoms among middle managers and employees
Description
Measured with Symptom Checklist, SCL-90-R
Time Frame
12 months
Title
Change in sleep quality among middle managers and employees
Description
Two items from the Karolinska Sleep Questionnaire. Items were answered on a 5 point Likert scale ranging 1 (bad) to extremely good (5)
Time Frame
Baseline, post training (6 months follow-up) and 12 months follow-up
Title
Change in knowledge on main topics among participating middle managers
Description
Self-formulated questions on degree of knowledge
Time Frame
Baseline, post training (6 months follow-up) and 12 months follow-up
Title
Change in attitudes towards managing well-being among participating middle managers
Description
Self-formulated questions on attitude
Time Frame
Baseline, post training (6 months follow-up) and 12 months follow-up
Title
Change in behavior aimed at managing well-being among participating middle managers
Description
Self-formulated questions on behavior
Time Frame
Baseline, post training (6 months follow-up) and 12 months follow-up
Title
Change in Perceived quality of patient care among employees
Description
Self-formulated questions on perceived quality of patient care
Time Frame
Baseline, post training (6 months follow-up) and 12 months follow-up

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vita LP Dalgaard, Ph.D
Phone
+4527124401
Email
ligayadalgaard@psy.au.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Christian B Jacobsen, Ph.D
Email
ChristianJ@ps.au.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vita LP Dalgaard, Ph.D
Organizational Affiliation
Aarhus BSS, Aarhus University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus Universitet
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ane-Kathrine aklh@ps.au.dk, MSc
Email
matterhorn@ps.au.dk
First Name & Middle Initial & Last Name & Degree
Christian B Jacobsen, Ph.D
Ext
Dalgaard
Email
ChristianJ@ps.au.dk
First Name & Middle Initial & Last Name & Degree
Vita LP Dalgaard, Ph.D

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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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Leading Well-being and the Psychosocial Working Environment - A Cluster-randomized Waitlist Controlled Trial

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