ClinicalTrials.gg
Not yet recruitingNCT07504042S4RUpdated Mar 31, 2026

Resilience Toolbox Intervention in Elderly Care

An interventional study of Support4Resilience toolbox in Mental Wellbeing of Older Adults, sponsored by University of Stavanger. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-31.

Sponsored by University of Stavanger · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
900
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

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.

02

Conditions studied

  • Mental Wellbeing of Older Adults

Keywords

  • mental wellbeing
  • resilience
  • elderly care
03

In context

Lead sponsor

University of Stavanger is the lead sponsor of 7 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Not actively working during the intervention period
  • Inability to complete questionnaires
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
900 participants (estimated)

Study arms

  • 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

  • No intervention
    Usual Practice

    Participants continue standard practice without access to the resilience toolbox during the study period.

Interventions

  • BehavioralSupport4Resilience 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From enrollment to the end of treatment at 12 months

Secondary outcomes

  1. 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.

    Time frame: From enrollment to the end of treatment at 12 months

  2. 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.

    Time frame: From enrollment to the end of treatment at 12 months

07

Study locations

No study locations are listed for this record.

08

References and documents

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 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Apr 2026; primary completion for Mar 2027, 11 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 20, 2026
First posted
Mar 31, 2026
StartEst.
Apr 1, 2026
Primary completionEst.
Mar 31, 2027
CompletionEst.
Mar 31, 2027
Last update
Mar 31, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07504042
Lead sponsor
University of Stavanger
Collaborators
Turku University of Applied Sciences
Responsible party
Daniel Adrian Lungu (Associate Professor, University of Stavanger) — Principal investigator
First posted
Mar 31, 2026
Start date
Apr 1, 2026 (estimated)
Primary completion
Mar 31, 2027 (estimated)
Completion
Mar 31, 2027 (estimated)
Last update
Mar 31, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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