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

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.

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

Study Overview

• Status: Recruiting
• Conditions: Stress; Well-being; Burn Out
• Intervention / Treatment: Behavioral: Training leaders in leading well-being and the psychosocial working environment; Behavioral: The offer of a webinar and written material

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vita LP Dalgaard, Ph.D; Phone Number: +4527124401; Email: ligayadalgaard@psy.au.dk
• Study Contact Backup: Name: Christian B Jacobsen, Ph.D; Email: ChristianJ@ps.au.dk

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Recruiting
    • Aarhus Universitet
    • Contact: Ane-Kathrine aklh@ps.au.dk, MSc; Email: matterhorn@ps.au.dk
    • Contact: Christian B Jacobsen, Ph.D; Email: ChristianJ@ps.au.dk
    • Principal Investigator: Vita LP Dalgaard, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; Leadership training comprising 5 modules and group exercises	Behavioral: Training 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: 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.
Other: Control group; Active control group receiving the offer of a webinar and written material	Behavioral: The offer of a webinar and written material; The offer of a webinar plus written material

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	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.	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	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)	Baseline, post training (6 months follow-up) and 12 months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)	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)	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)	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	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	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)	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	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)	Baseline, post training (6 months follow-up) and 12 months follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questions on readiness among participating middle managers	Self-formulated process questions on readiness and adherence	12 months
Compliance with training programme among participating middle managers	Measured with administrative data on attendance at each module of the training program	6 months
Distress symptoms among middle managers and employees	Measured with Symptom Checklist, SCL-90-R	12 months
Change in sleep quality among middle managers and employees	Two items from the Karolinska Sleep Questionnaire. Items were answered on a 5 point Likert scale ranging 1 (bad) to extremely good (5)	Baseline, post training (6 months follow-up) and 12 months follow-up
Change in knowledge on main topics among participating middle managers	Self-formulated questions on degree of knowledge	Baseline, post training (6 months follow-up) and 12 months follow-up
Change in attitudes towards managing well-being among participating middle managers	Self-formulated questions on attitude	Baseline, post training (6 months follow-up) and 12 months follow-up
Change in behavior aimed at managing well-being among participating middle managers	Self-formulated questions on behavior	Baseline, post training (6 months follow-up) and 12 months follow-up
Change in Perceived quality of patient care among employees	Self-formulated questions on perceived quality of patient care	Baseline, post training (6 months follow-up) and 12 months follow-up

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Central Denmark Region
• Investigators: Principal Investigator: Vita LP Dalgaard, Ph.D, Aarhus BSS, Aarhus University

Publications and helpful links

General 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.
• Skakon 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.
• Harms 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.
• Milligan-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.
• Taris 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.
• Harvey 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. Review.
• Nieuwenhuijsen 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.
• Ladegaard Y, Skakon J, Elrond AF, Netterstrøm 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.
• Bryan 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.
• Tafvelin 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.
• Lacerenza 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.
• Nielsen K, Abildgaard JS. Organizational interventions: A research-based framework for the evaluation of both process and effects. Work & Stress. 2013;27:278-97.
• Franke, F., Felfe, J., and Pundt, A. (2014). The impact of health-oriented leadership on follower health: development and test of a new instrument measuring health-promoting leadership. German J. Hum. Resour. Manag. 28, 139-161. doi: 10.1177/239700221402800108
• Eskildsen A, Dalgaard VL, Nielsen KJ, Andersen JH, Zachariae R, Olsen LR, Jorgensen A, Christiansen DH. Cross-cultural adaptation and validation of the Danish consensus version of the 10-item Perceived Stress Scale. Scand J Work Environ Health. 2015 Sep 1;41(5):486-90. doi: 10.5271/sjweh.3510. Epub 2015 Jun 25.
• Kristensen TS, Borritz M, Villadsen E, Christensen KB. The Copenhagen Burnout Inventory: a new tool for the assessment of burnout. Work Stress 2005;19:192-207.
• Clausen T, Madsen IE, Christensen KB, Bjorner JB, Poulsen OM, Maltesen T, Borg V, Rugulies R. The Danish Psychosocial Work Environment Questionnaire (DPQ): Development, content, reliability and validity. Scand J Work Environ Health. 2019 Jul 1;45(4):356-369. doi: 10.5271/sjweh.3793. Epub 2018 Dec 28.
• Olsen LR, Mortensen EL, Bech P. The SCL-90 and SCL-90R versions validated by item response models in a Danish community sample. Acta Psychiatr Scand. 2004 Sep;110(3):225-9.
• Bech P, Olsen LR, Kjoller M, Rasmussen NK. Measuring well-being rather than the absence of distress symptoms: a comparison of the SF-36 Mental Health subscale and the WHO-Five Well-Being Scale. Int J Methods Psychiatr Res. 2003;12(2):85-91. doi: 10.1002/mpr.145.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2022
• Primary Completion (Anticipated): January 8, 2024
• Study Completion (Anticipated): January 8, 2024

Study Registration Dates

• First Submitted: October 12, 2022
• First Submitted That Met QC Criteria: November 14, 2022
• First Posted (Actual): November 21, 2022

Study Record Updates

• Last Update Posted (Actual): November 21, 2022
• Last Update Submitted That Met QC Criteria: November 14, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Manager training; stress; well-being; the psychosocial working environment
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Burnout, Psychological
• Other Study ID Numbers: MATTERHORN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Due to data security regulation is it not possible to make individual participant data available to other researchers outside Aarhus University

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No