Resilience Toolbox Intervention in Elderly Care (S4R)

March 26, 2026 updated by: Daniel Adrian Lungu, University of Stavanger

Effectiveness of a Leader-Led Resilience Toolbox Intervention on Mental Wellbeing, Burnout, and Turnover Intention in Elderly Care Workers: A Cluster Randomized Controlled Trial With Repeated Measures

The goal of this cluster randomized controlled trial is to test if the Support4Resilience toolbox can improve mental wellbeing of healthcare workers in elderly care. The main questions it aims to answer is:

Is the Support4Resilience toolbox effective in improving the mental wellbeing of healthcare workers in elderly care?

Researchers will compare an intervention and a control group to see if the use of the Support4Resilience toolbox improves the mental wellbeing of the intervention arm participants.

Participants will be given access to the toolbox and structured workshops will be organized for them to use it. Participants in the control arm will not have access to the toolbox and no other alternative activities are planned.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a cluster randomized controlled trial conducted within the Support4Resilience (S4R) project, aiming to evaluate the effectiveness of a structured resilience intervention ("toolbox") in improving mental wellbeing among healthcare workers in elderly care settings.

The study is conducted in two countries, Norway and Finland, and includes a total of 30 clusters (15 per country). Clusters are defined as organizational units within elderly care settings (each municipality has 1 or more units), within which leaders and healthcare workers participate jointly in the intervention. The average cluster size is approximately 30 healthcare workers.

The intervention is designed as a leader-supported, practice-oriented program consisting of a series of structured workshops in which leaders and healthcare workers collaboratively engage with and implement tools targeting mental wellbeing organizational resilience. The toolbox includes strategies to enhance coping, communication, reflection, and supportive work practices. The intervention is implemented at the cluster level, reflecting its organizational focus and minimizing contamination between participants.

Clusters are randomized to either the intervention group or a control group. Clusters allocated to the intervention group receive access to the Support4Resilience toolbox and participate in a sequence of five main workshops, followed by a final workshop focused on reflection and discussion of results. The intervention is delivered over a period of approximately 12 months. The timing of workshops is adapted to local organizational needs, but they are generally conducted at intervals of approximately 2-3 months. Between workshops, participants are encouraged to apply and integrate the toolbox components into daily practice. Clusters in the control group continue with usual practice and do not receive access to the toolbox during the study period.

Data are collected at six time points: one baseline assessment prior to the start of the intervention and five follow-up assessments conducted after each of the main workshops. This repeated-measures design allows for the evaluation of both overall intervention effects and changes over time.

The primary outcome is mental wellbeing, measured using the Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS). Secondary outcomes include burnout, assessed using the Maslach Burnout Inventory (MBI), and intention to leave the job, measured using the Michigan Organizational Assessment Questionnaire (MOAQ). All outcomes are collected through self-administered questionnaires. Based on expected participation patterns, a response rate of at least 30% across all six measurement points is anticipated.

Due to the nature of the intervention, participants and implementers cannot be blinded to group allocation. However, outcome assessment is standardized across groups and time points using validated instruments, and statistical analyses will be conducted according to a predefined analysis plan.

Assuming an intra-cluster correlation coefficient of 0.05, this design is expected to provide adequate power to detect a moderate intervention effect on the primary outcome, while accounting for clustering. The repeated-measures design and use of mixed-effects models are expected to further improve efficiency by incorporating all available observations over time.

The findings of this study are expected to provide robust evidence on the effectiveness of organizational and leadership-supported interventions to promote mental wellbeing and resilience among healthcare workers in elderly care, and to inform future implementation and scale-up across different healthcare systems.

Study Type

Interventional

Enrollment (Estimated)

900

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthcare workers and leaders in elderly care settings
  • Employed in participating organizations in Norway and Finland
  • Able to provide informed consent

Exclusion Criteria:

  • Not actively working during the intervention period
  • Inability to complete questionnaires

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Resilience Toolbox Intervention
Participants receive a structured intervention consisting of multiple workshops delivered to leaders and staff. The workshops focus on implementing a resilience toolbox targeting mental wellbeing, stress management, and organizational support.
Behavioral: Support4Resilience toolbox

The Support4Resilience toolbox includes 3 tools that elderly care leaders will use in collaboration with their workers. The tools are the following:

  1. Mapping and identification tool: it provides leaders with a holistic awareness of the current status of the organization through integrating healthcare workers' and informal caregivers' perspectives.
  2. Reflection and education tool: it provides contextual understanding of 'work-as-done' rather than 'work-as-imagined', and educational components to identify successful adaptations and solutions to reduce capacity-demand gaps.
  3. Re-organization tool: designed to help reframing by identifying which practices to preserve, which to implement, and which to de-implement, resulting in detailed action plans.
No Intervention: Usual Practice
Participants continue standard practice without access to the resilience toolbox during the study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mental wellbeing
Time Frame: From enrollment to the end of treatment at 12 months
Mental wellbeing is measured through the Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS). It consists of 7 items assessed on a 5-points Likert scale. The total score is the sum of the item scores and ranges between 7 and 35. A higher score corresponds to a better mental wellbeing.
From enrollment to the end of treatment at 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Work-related burnout
Time Frame: From enrollment to the end of treatment at 12 months
Work-related burnout is one of the dimensions of the Copenhagen Burnout Inventory. It consists of 7 items with response options on a 5-points likert scale. Responses are converted to a 0-100 scale and the total score is calculated as the mean of the 7 items. A higher score indicates a higher level of work-related burnout.
From enrollment to the end of treatment at 12 months
Turnover intentions
Time Frame: From enrollment to the end of treatment at 12 months
The outcome is measured by the Michigan Organizational Assessment Questionnaire Turnover Intentions Scale. It consists of 4 items with response options on a 7-points Likert scale. The total score is calculated as the mean of the 4 items and a higher score indicates a higher intention to leave the job.
From enrollment to the end of treatment at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Stavanger

Collaborators

Turku University of Applied Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

March 20, 2026

First Submitted That Met QC Criteria

March 26, 2026

First Posted (Actual)

March 31, 2026

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • S4R-WP4-cRCT
  • 101136291 (Other Grant/Funding Number: European Commission)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Mental Wellbeing of Older Adults

Clinical Trials on Support4Resilience toolbox

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Pakistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe