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

Primary Purpose

Stress, Psychological, Mental Health Issue

Status
Active
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Engaged and Resilient intervention
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stress, Psychological focused on measuring Resilience, Positive mental health, Well-being

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Aahus University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in mental well-being
The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS-14) is a 14-item scale with 5 response categories.
Change in well-being (flourishing)
The Flourishing Scale is a 10-item scale with different (5,4 and 10) response categories.

Secondary Outcome Measures

Change in perceived stress
The Perceived Stress Scale (PSS) is a 10-item scale with 5 response categories.
Change in work-related resilience
The resilience at work (RAW) Scale is a 20-item scale with 7 response categories.
Change in resilience
The CD-RISC 10 Scale is a 10-item scale with 5 response categories.
Job performance
The question on job performance (Pronk et al., 2004) has 10 response categories.

Full Information

First Posted
January 22, 2021
Last Updated
November 22, 2022
Sponsor
University of Aarhus
Collaborators
University of Southern Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT04727255
Brief Title
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

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 19, 2020 (Actual)
Primary Completion Date
February 2, 2022 (Actual)
Study Completion Date
February 2, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
University of Southern Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological, Mental Health Issue
Keywords
Resilience, Positive mental health, Well-being

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, controlled (two parallel groups)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Engaged and Resilient intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in mental well-being
Description
The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS-14) is a 14-item scale with 5 response categories.
Time Frame
-1 month intervention (baseline), week 10, +1 month post intervention
Title
Change in well-being (flourishing)
Description
The Flourishing Scale is a 10-item scale with different (5,4 and 10) response categories.
Time Frame
-1 month intervention (baseline), week 10, +1 month post intervention
Secondary Outcome Measure Information:
Title
Change in perceived stress
Description
The Perceived Stress Scale (PSS) is a 10-item scale with 5 response categories.
Time Frame
-1 month intervention (baseline), week 10, +1 month post intervention
Title
Change in work-related resilience
Description
The resilience at work (RAW) Scale is a 20-item scale with 7 response categories.
Time Frame
-1 month intervention (baseline), week 10, +1 month post intervention
Title
Change in resilience
Description
The CD-RISC 10 Scale is a 10-item scale with 5 response categories.
Time Frame
-1 month intervention (baseline), week 10, +1 month post intervention
Title
Job performance
Description
The question on job performance (Pronk et al., 2004) has 10 response categories.
Time Frame
-1 month intervention (baseline), week 10, +1 month post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans Henrik Knoop
Organizational Affiliation
University of Aarhus
Official's Role
Study Director
Facility Information:
Facility Name
Aahus University
City
Aarhus
State/Province
Aarhus C
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

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

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