- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04727255
Engaged and Resilient - a Preventive Intervention to Promote Psychological Well-being and Mental Health for Leaders
Engaged and Resilient - a Preventive Resilience Intervention to Promote Psychological Well-being and Mental Health for Leaders in Organizations
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).
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Aarhus C
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Aarhus, Aarhus C, Denmark, 8000
- Aahus University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
The intervention will be implemented through a group-based delivery format involving internal educated resilience trainers.
The Engaged and Resilient training program consists of twenty weekly, short-term sessions to build resilience skills in leaders.
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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. |
|
No Intervention: Control
Participants in the (waitlist) control group will be exposed to their usual activities in the organization and will not perceive any interventions from the resilience curriculum.
After the final data is collected, the control participant will be offered the opportunity to be trained by the internal trainers, educated in the research study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in mental well-being
Time Frame: -1 month intervention (baseline), week 10, +1 month post intervention
|
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
|
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Change in well-being (flourishing)
Time Frame: -1 month intervention (baseline), week 10, +1 month post intervention
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in perceived stress
Time Frame: -1 month intervention (baseline), week 10, +1 month post intervention
|
The Perceived Stress Scale (PSS) is a 10-item scale with 5 response categories.
|
-1 month intervention (baseline), week 10, +1 month post intervention
|
|
Change in work-related resilience
Time Frame: -1 month intervention (baseline), week 10, +1 month post intervention
|
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
|
|
Change in resilience
Time Frame: -1 month intervention (baseline), week 10, +1 month post intervention
|
The CD-RISC 10 Scale is a 10-item scale with 5 response categories.
|
-1 month intervention (baseline), week 10, +1 month post intervention
|
|
Job performance
Time Frame: -1 month intervention (baseline), week 10, +1 month post intervention
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The question on job performance (Pronk et al., 2004) has 10 response categories.
|
-1 month intervention (baseline), week 10, +1 month post intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Hans Henrik Knoop, University of Aarhus
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AU_IM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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