NCT04727255

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 19, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 27, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2023

Completed
Last Updated

November 29, 2022

Status Verified

June 1, 2022

Enrollment Period

1.3 years

First QC Date

January 22, 2021

Last Update Submit

November 22, 2022

Conditions

Keywords

ResiliencePositive mental healthWell-being

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (4)

  • Change in perceived stress

    -1 month intervention (baseline), week 10, +1 month post intervention

  • Change in work-related resilience

    -1 month intervention (baseline), week 10, +1 month post intervention

  • Change in resilience

    -1 month intervention (baseline), week 10, +1 month post intervention

  • Job performance

    -1 month intervention (baseline), week 10, +1 month post intervention

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: Engaged and Resilient intervention

Control

NO INTERVENTION

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.

Interventions

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.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Not willing and able to give informed consent
  • Not willing to complete surveys at all time points

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aahus University

Aarhus, Aarhus C, 8000, Denmark

Location

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Hans Henrik Knoop

    University of Aarhus

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized, controlled (two parallel groups)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2021

First Posted

January 27, 2021

Study Start

October 19, 2020

Primary Completion

February 2, 2022

Study Completion

February 2, 2023

Last Updated

November 29, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations