Viewing Study NCT05623371



Ignite Creation Date: 2024-05-06 @ 6:19 PM
Last Modification Date: 2024-10-26 @ 2:45 PM
Study NCT ID: NCT05623371
Status: UNKNOWN
Last Update Posted: 2022-11-21
First Post: 2022-10-12

Brief Title: Leading Well-being and the Psychosocial Working Environment - A Cluster-randomized Waitlist Controlled Trial
Sponsor: University of Aarhus
Organization: University of Aarhus

Study Overview

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
Status: UNKNOWN
Status Verified Date: 2022-09
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: Matterhorn
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None