Engaged and Resilient - a Preventive Intervention to Promote Psychological Well-being and Mental Health for Leaders

Stress, Psychological Clinical Trial

Official title:

Engaged and Resilient - a Preventive Resilience Intervention to Promote Psychological Well-being and Mental Health for Leaders in Organizations

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04727255
• Other study ID #: AU_IM
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 19, 2020
• Est. completion date: February 2, 2023

Study information

• Verified date: June 2022
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Leaders in organizations must handle organizational complexity and adversity as part of their position and profession. Work-related risk exposure is associated with perceived stress, low engagement, and mental health issues. However, not all leaders exposed to risk experience adverse outcomes, and one possible explanation might be their psychological ability to adapt to the organizational turbulence.

Engaged and Resilient is a research project for leaders in private and public organizations. The overall objective is to improve human health and performance, more specifically, to promote psychological and mental health by enhancing the resilience capacities to face adversity and adapt to the organizational environment. The Engaged and Resilient intervention is a flexible training program for leaders implemented as a 20-week program on-site (adjusted due to Covid-19).

Description:

Research design:

The study involves program development, implementation, and evaluation of resilience training by a randomized controlled research design. The participant will be randomized to the intervention group to receive the resilience training program "Engaged and Resilient" or a wait-list control group to receive the resilience training conducted by internal educated trainers following the post-intervention measures.

Pre- and post measures include mental health, flourishing, perceived stress, resilience (two scales), and work-related performance (one-item). The training effects will be measured after each training session on a 4-point scale to create knowledge about the specific resilience promoting factors and the implementation process.

The intervention project will consist of an organizational supporting system and didactic component, including an internal trainer education for the Management/HR and more specific for the participants (leaders): Psychoeducation, psychological skill-building training, and ongoing homework exercises to support the implementation of resilience strategies within the organizational context.

Operational objectives:

• To develop a flexible (co-customized, co-implemented) resilience training program for leaders in organizations structured as thee general resilience factors with specific training sessions within each

• To implement a resilience intervention for leaders in public and private Danish organizational environments

• To demonstrate outcome effects on human health and performance. Primary in terms of mental health and well-being, and secondary in perceived stress, resilience, work-related performance, and sick-leave

• To provide evidence of specific resilience factors promoting positive mental health and well-being longitudinally (20 weeks)

• To create knowledge about the implementation and change process by ongoing participant evaluation of the specific training sessions

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1
• Est. completion date: February 2, 2023
• Est. primary completion date: February 2, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18+ years

• Being a formal leader or having a specific leading role in a professional or functional area in the organization

• Accept the commitment to attendance in interventions groups and all sessions

Exclusion Criteria:

• Not willing and able to give informed consent

• Not willing to complete surveys at all time points

Related Conditions & MeSH terms

• Mental Health Issue
• Stress, Psychological

Intervention

Behavioral:
• Engaged and Resilient intervention
Engaged and Resilient is a 3-phase program addressing the promotion of psychological resilience strategies for leaders. To implement resilience training as a strategic and ethical intervention in the organization, stakeholders from Management/HR will be involved in the final design of the training program based on local institutional data, and the baseline measure result. Local training sessions will be selected from a bag-log of resilience skills structured by three general resilience factors. To support ownership and internal sustainability, internal trainers will be educated on how to train the resilience skills in the program. The Engaged and Resilient program consists of 20 short-term sessions for leaders based on cognitive and positive psychology.

Locations

Country	Name	City	State
Denmark	Aahus University	Aarhus	Aarhus C

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mental well-being	The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS-14) is a 14-item scale with 5 response categories.	-1 month intervention (baseline), week 10, +1 month post intervention
Primary	Change in well-being (flourishing)	The Flourishing Scale is a 10-item scale with different (5,4 and 10) response categories.	-1 month intervention (baseline), week 10, +1 month post intervention
Secondary	Change in perceived stress	The Perceived Stress Scale (PSS) is a 10-item scale with 5 response categories.	-1 month intervention (baseline), week 10, +1 month post intervention
Secondary	Change in work-related resilience	The resilience at work (RAW) Scale is a 20-item scale with 7 response categories.	-1 month intervention (baseline), week 10, +1 month post intervention
Secondary	Change in resilience	The CD-RISC 10 Scale is a 10-item scale with 5 response categories.	-1 month intervention (baseline), week 10, +1 month post intervention
Secondary	Job performance	The question on job performance (Pronk et al., 2004) has 10 response categories.	-1 month intervention (baseline), week 10, +1 month post intervention