Clinical trial NCT04727255: Engaged and Resilient - a Preventive Intervention to Promote Psychological Well-being and Mental Health for Leaders
Official title: Engaged and Resilient - a Preventive Resilience Intervention to Promote Psychological Well-being and Mental Health for Leaders in Organizations
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress, Psychological
Mental Health Issue
Keywords: Resilience
Positive mental health
Well-being
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
First posted: 2021-01-27
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled (two parallel groups)
Primary purpose: PREVENTION

Brief 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).

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Change in mental well-being
timeFrame: -1 month intervention (baseline), week 10, +1 month post intervention
measure: Change in well-being (flourishing)
timeFrame: -1 month intervention (baseline), week 10, +1 month post intervention
Secondary outcomes:
measure: Change in perceived stress
timeFrame: -1 month intervention (baseline), week 10, +1 month post intervention
measure: Change in work-related resilience
timeFrame: -1 month intervention (baseline), week 10, +1 month post intervention
measure: Change in resilience
timeFrame: -1 month intervention (baseline), week 10, +1 month post intervention
measure: Job performance
timeFrame: -1 month intervention (baseline), week 10, +1 month post intervention
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aahus University
state: Aarhus C
Study officials:
affiliation: University of Aarhus
name: Hans Henrik Knoop
role: STUDY_DIRECTOR
References: