Mental Wellbeing of Older AdultsS4RNCT07504042
Resilience Toolbox Intervention in Elderly Care
A study testing Support4Resilience toolbox in people with Mental Wellbeing of Older Adults, run by University of Stavanger.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Wellbeing of Older Adults
- What is being tested?
- Support4Resilience toolbox
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthcare workers and leaders in elderly care settings
- Employed in participating organizations in Norway and Finland
- Able to provide informed consent
Who cannot join
- Not actively working during the intervention period
- Inability to complete questionnaires
About this study
Official title: 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?
Read more
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.
Read the 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.
- Conditions
- Mental Wellbeing of Older Adults
- Being tested
- Support4Resilience toolbox
- Keywords
- mental wellbeing, resilience, elderly care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Support4Resilience toolboxBehavioural
The Support4Resilience toolbox includes 3 tools that elderly care leaders will use in collaboration with their workers. The tools are the following:
- 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.
- 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.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Resilience Toolbox Intervention | Experimental | 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. Receives: Behavioral: Support4Resilience toolbox |
| Usual Practice | No intervention | Participants continue standard practice without access to the resilience toolbox during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental wellbeing
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.
Measured: From enrollment to the end of treatment at 12 months
Secondary outcomes (2)
Work-related burnout
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.
Measured: From enrollment to the end of treatment at 12 months
Turnover intentions
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.
Measured: From enrollment to the end of treatment at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental Wellbeing of Older AdultsStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Stavanger
- Sponsor type
- University, hospital or other
- Collaborators
- Turku University of Applied Sciences
- Responsible party
- Principal investigator, Daniel Adrian Lungu, University of Stavanger
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07504042
- Sponsor's protocol ID
- S4R-WP4-cRCT
- Other IDs
- 101136291
- Acronym
- S4R
- Status last verified
- Mar 2026
- First submitted
- 20 Mar 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lyng HB, Haraldseid-Driftland C, Lungu DA, Viksveen P, Akerjordet K, Glette MK, Ree E, Guise V, Haver A, Bergerod IJ, Kankaanpaa E, Kapitsaki GM, Chatzittofis A, Ellis LA, Bal R, Tibu F, Delgado-Saborit JM, Tolosa A, Cantarelli P, Vola F, Lahti M, Parmentier H, Raknes Sogstad MK, Engel C, Vincent C, Braithwaite J, Pfaff H, Wiig S. Strengthening Resilience and Mental Well-Being Through the Support4Resilience Toolbox for Leaders in Older Adult Care: Protocol for a Cross-Country Mixed Methods Study (Support4Resilience). JMIR Res Protoc. 2026 Jul 20;15:e73701. doi: 10.2196/73701.
PubMed 42475674
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07504042
- Acronym / sponsor ID
- S4R / S4R-WP4-cRCT
- Conditions
- Mental Wellbeing of Older Adults
- Keywords
- mental wellbeing, resilience, elderly care
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- University of StavangerUniversity, hospital or other
- Collaborators
- Turku University of Applied Sciences
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 31 Mar 2026 (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.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resilience Toolbox Intervention | Experimental | Behavioral: Support4Resilience toolboxParticipants 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. |
| Usual Practice | No intervention | –Participants continue standard practice without access to the resilience toolbox during the study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthcare workers and leaders in elderly care settings
- Employed in participating organizations in Norway and Finland
- Able to provide informed consent
Key exclusion criteria (2 listed)
- Not actively working during the intervention period
- Inability to complete questionnaires
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 |
|---|---|---|
| Support4Resilience toolboxThe 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. | Behavioural | Resilience Toolbox Intervention |
Primary outcome
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.
2 secondary outcomes
Work-related burnout
Time frame: From enrollment to the end of treatment at 12 months
Turnover intentions
Time frame: From enrollment to the end of treatment at 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Derived from this study: PubMed 42475674Lyng HB, Haraldseid-Driftland C, Lungu DA, Viksveen P, Akerjordet K, Glette MK, Ree E, Guise V, Haver A, Bergerod IJ, Kankaanpaa E, Kapitsaki GM, Chatzittofis A, Ellis LA, Bal R, Tibu F, Delgado-Saborit JM, Tolosa A, Cantarelli P, Vola F, Lahti M, Parmentier H, Raknes Sogstad MK, Engel C, Vincent C, Braithwaite J, Pfaff H, Wiig S. Strengthening Resilience and Mental Well-Being Through the Support4Resilience Toolbox for Leaders in Older Adult Care: Protocol for a Cross-Country Mixed Methods Study (Support4Resilience). JMIR Res Protoc. 2026 Jul 20;15:e73701. doi: 10.2196/73701.
Related trials for Mental Wellbeing of Older Adults
Not yet recruiting
Effects of Positive Psychology on Hope, Gratitude, and Well-Being
Elderly, Nursing Homes
Active, not recruiting
Multimodal Training With Immersive Virtual Reality to Improve the Cognitive Health and Emotional Well-being of Older Women Living Alone
Social Isolation in Older Adults, Poverty
Not yet recruiting
A Virtual Reality Program for Nursing Home Residents With Physical Disabilities
Older Adults Institutionalized in Residential Homes
Recruiting
Virtual Nature Versus Guided Imagery for Anxiety and Well-Being in Hospitalized Older Adults
Anxiety, Hospitalization
Not yet recruiting
Thrive at Home: A Virtual Reality Social Intervention for Older Adults
Mental Health (Depression), Mental Health and General Well-being
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Support4Resilience toolbox in people with Mental Wellbeing of Older Adults, run by University of Stavanger.
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: opening soon, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Mental wellbeing (time frame: From enrollment to the end of treatment at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07504042, which also lists 1 linked publication.
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 31 Mar 2026.