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

NCT05623371 | Unknown

• 1 other identifier: Matterhorn
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Stress; Well-being; Burn Out

Keywords

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

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (9)

• Change in Well-being among middle managers and employees

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

• Change in the perceived psychosocial working environment in middle managers and employees

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

• Change in perceive leadership quality among employees

  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

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

• Change in turnover intention among middle managers and employees

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

Other Outcomes (8)

• Questions on readiness among participating middle managers

  12 months

• Compliance with training programme among participating middle managers

  6 months

• Distress symptoms among middle managers and employees

  12 months

Study Arms (2)

Treatment group

EXPERIMENTAL

Leadership training comprising 5 modules and group exercises

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

Control group

OTHER

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

Behavioral: The offer of a webinar and written material

Interventions

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: 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.

Treatment group

The offer of a webinar and written material BEHAVIORAL

The offer of a webinar plus written material

Control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Central Denmark Region: collaborator

Study Sites (1)

Aarhus Universitet

Aarhus, 8000, Denmark

RECRUITING

Related Publications (23)

• 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.

  PMID: 32463101 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 29791510 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 29563195 BACKGROUND

• 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.

  PMID: 29031935 BACKGROUND

• Taris TW, Nielsen K. Leadership in occupational health psychology. Work & Stress. 2019;33(2):105-6.

  BACKGROUND

• 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. No abstract available.

  PMID: 30643919 BACKGROUND

• 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.

  PMID: 28108676 BACKGROUND

• 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. doi: 10.1136/oem.2003.009688.

  PMID: 15377767 BACKGROUND

• Ladegaard Y, Skakon J, Elrond AF, Netterstrom 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.

  PMID: 28845715 BACKGROUND

• 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.

  PMID: 30060150 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 34518756 BACKGROUND

• 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.

  PMID: 28749153 BACKGROUND

• Nielsen K, Abildgaard JS. Organizational interventions: A research-based framework for the evaluation of both process and effects. Work & Stress. 2013;27:278-97.

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 26111225 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 30592500 BACKGROUND

• 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. doi: 10.1111/j.1600-0447.2004.00399.x.

  PMID: 15283743 BACKGROUND

• 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.

  PMID: 12830302 BACKGROUND

• Dalgaard VL, Gayed A, Hansen AKL, Grytnes R, Nielsen K, Kirkegaard T, Uldall L, Ingerslev K, Skakon J, Jacobsen CB. A study protocol outlining the development and evaluation of a training program for frontline managers on leading well-being and the psychosocial work environment in Danish hospital settings - a cluster randomized waitlist controlled trial. BMC Public Health. 2023 May 10;23(1):848. doi: 10.1186/s12889-023-15728-2.

  PMID: 37165331 DERIVED

MeSH Terms

Conditions

Burnout, Psychological

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Vita LP Dalgaard, Ph.D

  Aarhus BSS, Aarhus University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vita LP Dalgaard, Ph.D

CONTACT

+4527124401; ligayadalgaard@psy.au.dk

Christian B Jacobsen, Ph.D

CONTACT

ChristianJ@ps.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: November 21, 2022
• Study Start: May 15, 2022
• Primary Completion: January 8, 2024
• Study Completion: January 8, 2024
• Last Updated: November 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)