Stress, PsychologicalNCT04727255
Engaged and Resilient - a Preventive Intervention to Promote Psychological Well-being and Mental Health for Leaders
A study testing Engaged and Resilient intervention in people with Stress, Psychological and Mental Health Issue, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological, Mental Health Issue
- What is being tested?
- Engaged and Resilient intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteDenmark
- Study dates
- 19 Oct 2020to 2 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not willing and able to give informed consent
- Not willing to complete surveys at all time points
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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
- Conditions
- Stress, Psychological, Mental Health Issue
- Being tested
- Engaged and Resilient intervention
- Keywords
- Resilience, Positive mental health, Well-being
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Engaged and Resilient interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mental well-being
The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS-14) is a 14-item scale with 5 response categories.
Measured: -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.
Measured: -1 month intervention (baseline), week 10, +1 month post intervention
Secondary outcomes (4)
Change in perceived stress
The Perceived Stress Scale (PSS) is a 10-item scale with 5 response categories.
Measured: -1 month intervention (baseline), week 10, +1 month post intervention
Change in work-related resilience
The resilience at work (RAW) Scale is a 20-item scale with 7 response categories.
Measured: -1 month intervention (baseline), week 10, +1 month post intervention
Change in resilience
The CD-RISC 10 Scale is a 10-item scale with 5 response categories.
Measured: -1 month intervention (baseline), week 10, +1 month post intervention
Job performance
The question on job performance (Pronk et al., 2004) has 10 response categories.
Measured: -1 month intervention (baseline), week 10, +1 month post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start19 Oct 2020
- Primary completion2 Feb 2022
- Study completion2 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled (two parallel groups)
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark
- Responsible party
- Sponsor
- Investigators
- Hans Henrik Knoop, Study director, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04727255
- Sponsor's protocol ID
- AU_IM
- Status last verified
- Jun 2022
- First submitted
- 22 Jan 2021
- Last updated
- 29 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaged and Resilient - a Preventive Resilience Intervention to Promote Psychological Well-being and Mental Health for Leaders in Organizations
- ClinicalTrials.gov ID
- NCT04727255
- Acronym / sponsor ID
- AU_IM
- Conditions
- Stress, Psychological, Mental Health Issue
- Keywords
- Resilience, Positive mental health, Well-being
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- University of Southern Denmark
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 2 Feb 2022 (actual)
- Study completion
- 2 Feb 2023 (estimated)
- First posted
- 27 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, controlled (two parallel groups)
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Engaged and Resilient interventionThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Not willing and able to give informed consent
- Not willing to complete surveys at all time points
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Engaged and Resilient interventionEngaged 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. | Behavioural | Intervention |
Primary outcome
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.
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.
4 secondary outcomes
Change in perceived stress
Time frame: -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
Change in resilience
Time frame: -1 month intervention (baseline), week 10, +1 month post intervention
Job performance
Time frame: -1 month intervention (baseline), week 10, +1 month post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans Henrik Knoop study director
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Engaged and Resilient intervention in people with Stress, Psychological and Mental Health Issue, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mental well-being (time frame: -1 month intervention (baseline), week 10, +1 month post intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2022.