Studies
| Study First Submitted Date | 2021-01-22 |
| Study First Posted Date | 2021-01-27 |
| Last Update Posted Date | 2022-11-29 |
| Start Month Year | October 19, 2020 |
| Primary Completion Month Year | February 2, 2022 |
| Verification Month Year | June 2022 |
| Verification Date | 2022-06-30 |
| Last Update Posted Date | 2022-11-29 |
Detailed Descriptions
| Sequence: | 20679309 |
| 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 |
Facilities
| Sequence: | 199596196 |
| Name | Aahus University |
| City | Aarhus |
| State | Aarhus C |
| Zip | 8000 |
| Country | Denmark |
Conditions
| Sequence: | 52059378 | Sequence: | 52059379 |
| Name | Stress, Psychological | Name | Mental Health Issue |
| Downcase Name | stress, psychological | Downcase Name | mental health issue |
Id Information
| Sequence: | 40069896 |
| Id Source | org_study_id |
| Id Value | AU_IM |
Countries
| Sequence: | 42467660 |
| Name | Denmark |
| Removed | False |
Design Groups
| Sequence: | 55470359 | Sequence: | 55470360 |
| Group Type | Experimental | Group Type | No Intervention |
| Title | Intervention | Title | Control |
| 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. | 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. |
Interventions
| Sequence: | 52371560 |
| Intervention Type | Behavioral |
| Name | Engaged and Resilient 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. |
Keywords
| Sequence: | 79684754 | Sequence: | 79684755 | Sequence: | 79684756 |
| Name | Resilience | Name | Positive mental health | Name | Well-being |
| Downcase Name | resilience | Downcase Name | positive mental health | Downcase Name | well-being |
Design Outcomes
| Sequence: | 176993480 | Sequence: | 176993481 | Sequence: | 176993482 | Sequence: | 176993483 | Sequence: | 176993484 | Sequence: | 176993485 |
| Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
| Measure | Change in mental well-being | Measure | Change in well-being (flourishing) | Measure | Change in perceived stress | Measure | Change in work-related resilience | Measure | Change in resilience | Measure | Job performance |
| Time Frame | -1 month intervention (baseline), week 10, +1 month post intervention | Time Frame | -1 month intervention (baseline), week 10, +1 month post intervention | Time Frame | -1 month intervention (baseline), week 10, +1 month post intervention | Time Frame | -1 month intervention (baseline), week 10, +1 month post intervention | Time Frame | -1 month intervention (baseline), week 10, +1 month post intervention | Time Frame | -1 month intervention (baseline), week 10, +1 month post intervention |
| Description | The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS-14) is a 14-item scale with 5 response categories. | Description | The Flourishing Scale is a 10-item scale with different (5,4 and 10) response categories. | Description | The Perceived Stress Scale (PSS) is a 10-item scale with 5 response categories. | Description | The resilience at work (RAW) Scale is a 20-item scale with 7 response categories. | Description | The CD-RISC 10 Scale is a 10-item scale with 5 response categories. | Description | The question on job performance (Pronk et al., 2004) has 10 response categories. |
Browse Conditions
| Sequence: | 193040011 | Sequence: | 193040012 |
| Mesh Term | Stress, Psychological | Mesh Term | Behavioral Symptoms |
| Downcase Mesh Term | stress, psychological | Downcase Mesh Term | behavioral symptoms |
| Mesh Type | mesh-list | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48215247 | Sequence: | 48215248 |
| Agency Class | OTHER | Agency Class | OTHER |
| Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
| Name | University of Aarhus | Name | University of Southern Denmark |
Overall Officials
| Sequence: | 29219951 |
| Role | Study Director |
| Name | Hans Henrik Knoop |
| Affiliation | University of Aarhus |
Design Group Interventions
| Sequence: | 67999979 |
| Design Group Id | 55470359 |
| Intervention Id | 52371560 |
Eligibilities
| Sequence: | 30699909 |
| Gender | All |
| Minimum Age | 18 Years |
| Maximum Age | N/A |
| Healthy Volunteers | Accepts Healthy Volunteers |
| 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 |
| Adult | True |
| Child | False |
| Older Adult | True |
Calculated Values
| Sequence: | 253914891 |
| Number Of Facilities | 1 |
| Registered In Calendar Year | 2021 |
| Actual Duration | 15 |
| Were Results Reported | False |
| Has Us Facility | False |
| Has Single Facility | True |
| Minimum Age Num | 18 |
| Minimum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 2 |
| Number Of Secondary Outcomes To Measure | 4 |
Designs
| Sequence: | 30446553 |
| Allocation | Randomized |
| Intervention Model | Parallel Assignment |
| Observational Model | |
| Primary Purpose | Prevention |
| Time Perspective | |
| Masking | None (Open Label) |
| Intervention Model Description | Randomized, controlled (two parallel groups) |
Responsible Parties
| Sequence: | 28813052 |
| Responsible Party Type | Sponsor |