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

Stress Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05623371
• Other study ID #: Matterhorn
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2022
• Est. completion date: January 8, 2024

Study information

• Verified date: September 2022
• Source: University of Aarhus
• Contact: Vita LP Dalgaard, Ph.D
• Phone: +4527124401
• Email: ligayadalgaard[@]psy.au.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 8, 2024
• Est. primary completion date: January 8, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Burn Out
• Burnout, Psychological
• Stress
• Well-being

Intervention

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.
• The offer of a webinar and written material
The offer of a webinar plus written material

Locations

Country	Name	City	State
Denmark	Aarhus Universitet	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Central Denmark Region

Country where clinical trial is conducted

Denmark, 

References & Publications (22)

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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. — View Citation

Eskildsen A, Dalgaard VL, Nielsen KJ, Andersen JH, Zachariae R, Olsen LR, Jørgensen 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. — View Citation

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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. — View Citation

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

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. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

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.

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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. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Questions on readiness among participating middle managers	Self-formulated process questions on readiness and adherence	12 months
Other	Compliance with training programme among participating middle managers	Measured with administrative data on attendance at each module of the training program	6 months
Other	Distress symptoms among middle managers and employees	Measured with Symptom Checklist, SCL-90-R	12 months
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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