Occupational StressAGIT-RESTS-1NCT06727682
Feasibility of Stress Management Education Delivered Via Virtual Classroom in Nursing Homes: a Pilot Study of a RCT
A study testing Stress management in people with Occupational Stress, run by GCS CIPS at 4 sites in France.
Trial summary
The aim of this cluster-randomised pilot study is to assess the feasibility of a remote stress management programme to reduce occupational stress in healthcare workers in specialised care units of nursing homes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Occupational Stress
- What is being tested?
- Stress management
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesFrance
- Study dates
- 2 Dec 2024to 22 May 2025
- 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
- Having a caring relationship with residents (e.g. nurses, nursing assistants)
- Working in the specialised care unit of the nursing home
- Working in the nursing home for at least 3 months on the date of inclusion and whose employment contract does not end within 3 months of the date of inclusion.
- Obtaining express written informed consent, after a period of reflection
Who cannot join
- Person in a period of relative exclusion in relation to another protocol
- Person who is not affiliated to or does not benefit from a social security scheme.
- Pregnant or lactating woman
- Participant unable to give consent
- Person deprived of liberty by judicial or administrative decision
- Person unable to understand, speak, read and write French
Trial locations and contacts
4 sites in 1 country.
France4 sites
Korian La Colombe
Gigean, France, 34770
Korian Le Clos de l'orchidée
Narbonne, Occitanie, 11100
Korian Parc de l'abbaye
Saint-Cyr-l'École, Île-de-France Region, 78210
Korian Parc des dames
Saint-Germain-en-Laye, Île-de-France Region
About this study
Official title: Feasibility and Relevance of Stress Management Education Delivered Via Virtual Classroom for Carers Working in Specialised Care Units in Nursing Homes: a Pilot Study of a Randomized Controlled Trial
The aim of this cluster-randomised pilot study is to assess the feasibility of a remote stress management programme to reduce occupational stress in healthcare workers in specialised care units of nursing homes. Secondary aims are to assess the effectiveness of the programme in reducing stress in care workers and reducing behavioural and psychological symptoms of dementia in residents.
Participants randomised to the experimental cluster will follow the stress management programme delivered in a virtual classroom. Participants randomised to the control cluster will be placed on a waiting list.
Read more
The primary outcome measure will be the participation rate in the study. Other secondary outcomes will include measures of heart rate variability (as a marker of physiological stress) and scores on specific questionnaires for stress, anxiety and risk of burnout in nursing staff in the specialised care units, and behavioural and psychological symptoms of dementia and quality of life in residents in the specialised care units.
Both clusters will complete the same assessments. Participants in the experimental cluster will follow a three-course programme with a psychologist via videoconferencing over a period of 2 months. After the study's final evaluation visit, which will take place one month after the programme, participants in the control cluster will be offered the opportunity to follow the same programme.
- Conditions
- Occupational Stress
- Being tested
- Stress management
- Keywords
- stress management, virtual classroom, risk of burnout, behavioural and psychological symptoms of dementia
- Medical subject headings
- Occupational Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress managementBehavioural
Ten-hour, three-course stress management programme with a psychologist via video conferencing over a 2 month period. The classes will be delivered in small groups of maximum seven care workers. Carers can be brought together in the same room, but the speaker will necessarily be at a distance, via videoconferencing. The formation will adress the following issues: i) Understanding the mechanisms of stress, ii) Identifying sources of stress and triggers, iii) Anticipate stressful situations and use their resources to prevent them, and iv) Use the most appropriate stress-reduction techniques, depending on their sensitivity.
| Study group | Role | What they receive |
|---|---|---|
| Remote stress management programme | Experimental | Ten-hour, three-course stress management programme with a psychologist via video conferencing over 2 months Receives: Behavioral: Stress management |
| Waiting list | No intervention | No intervention during the study duration. However, after the end of the study, after the last evaluations, participants in this control cluster will be offered the opportunity to follow the stress management programme. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation rate
Participation rate defined as the ratio of the number of participants who completed all study visits to the number of care professionals who agreed to participate.
Measured: From enrollment to the end of the study at 3 months
Secondary outcomes (16)
Acceptance rate
Ratio between the total number of eligible healthcare workers and the number of healthcare worker who accept to be enrolled in the study.
Measured: At enrollment
Retention rate
Ratio between the number of care professionals still present at the last visit of the study and the number of care professionals included in the study
Measured: From enrollment to the end of the study at 3 months
Adherence
Average number of visits attended by each participant.
Measured: From the beginning to the end of the study, at 3 months
Quality of the intervention
Feedback on the relevance of the training and its contribution through semi-directive interviews and focus groups in participants and in managers and directors of the nursing homes.
Measured: At the end of the intervention, at 3 months
Cost of the programme
Total cost of the stress management program including the costs incurred to enable the employee to follow the training and/or the costs incurred to replace the absence of the employee in the service
Measured: From enrollment to the end of the study at 3 months
Heart rate variability
Recording of resting heart rate variability assessed by RMSSD, SDNN, LF and HF markers.
Measured: Baseline and 3 months
Occupational stress
Score on the Work Place Stress Scale
Measured: Baseline, 2 months and 3 months
Overall stress
Score on the Perceived Stress Scale-10
Measured: Baseline, 2 months and 3 months
Job satisfaction
Score on the Overall Job Satisfaction Scale
Measured: Baseline, 2 months and 3 months
Risk of burn-out
Score on the Malasch Burnout Inventory
Measured: Baseline, 2 months and 3 months
Quality of life
Score on the World Health Organization Quality of Life questionnaire
Measured: Baseline, 2 months and 3 months
Self-rated health
Score on the self-rated health scale
Measured: Baseline, 2 months and 3 months
Anxiety
Score on the Generalized Anxiety Disorder 7-Item
Measured: Baseline, 2 months and 3 months
Perceptions of the quality of patient care
Score on the Victorian Patient Satisfaction Questionnaire
Measured: Baseline, 2 months and 3 months
Substance use
Usual substance use (tobacco, alcohol, drugs...), assessed by a questionnaire that records the type of substance and frequency of use.
Measured: Baseline, 2 months and 3 months
Knowledge and mastery of stress management tools
Score on a multiple-choice questionnaire specially designed for the study
Measured: Baseline, 2 months and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start2 Dec 2024
- Primary completion22 May 2025
- Study completion22 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occupational StressStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster-randomised pilot study with four specialised care units of nursing homes and two clusters. Two specialised care units will be randomized in the experimental cluster, and the other ones will be randomized in the control cluster.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- GCS CIPS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fariba Kabirian, MD, Principal investigator, France Chief Medical Officer, Clariane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06727682
- Sponsor's protocol ID
- AGIT-RESTS-1
- Acronym
- AGIT-RESTS-1
- Status last verified
- Aug 2025
- First submitted
- 29 Nov 2024
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Relevance of Stress Management Education Delivered Via Virtual Classroom for Carers Working in Specialised Care Units in Nursing Homes: a Pilot Study of a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06727682
- Acronym / sponsor ID
- AGIT-RESTS-1 / AGIT-RESTS-1
- Conditions
- Occupational Stress
- Keywords
- stress management, virtual classroom, risk of burnout, behavioural and psychological symptoms of dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- GCS CIPSUniversity, hospital or other
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- 22 May 2025 (actual)
- Study completion
- 22 May 2025 (actual)
- First posted
- 11 Dec 2024 (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 aim of this cluster-randomised pilot study is to assess the feasibility of a remote stress management programme to reduce occupational stress in healthcare workers in specialised care units of nursing homes. Secondary aims are to assess the effectiveness of the programme in reducing stress in care workers and reducing behavioural and psychological symptoms of dementia in residents.
Participants randomised to the experimental cluster will follow the stress management programme delivered in a virtual classroom. Participants randomised to the control cluster will be placed on a waiting list.
The primary outcome measure will be the participation rate in the study. Other secondary outcomes will include measures of heart rate variability (as a marker of physiological stress) and scores on specific questionnaires for stress, anxiety and risk of burnout in nursing staff in the specialised care units, and behavioural and psychological symptoms of dementia and quality of life in residents in the specialised care units.
Both clusters will complete the same assessments. Participants in the experimental cluster will follow a three-course programme with a psychologist via videoconferencing over a period of 2 months. After the study's final evaluation visit, which will take place one month after the programme, participants in the control cluster will be offered the opportunity to follow the same programme.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster-randomised pilot study with four specialised care units of nursing homes and two clusters. Two specialised care units will be randomized in the experimental cluster, and the other ones will be randomized in the control cluster.
| Arm | Type | Receives |
|---|---|---|
| Remote stress management programme | Experimental | Behavioral: Stress managementTen-hour, three-course stress management programme with a psychologist via video conferencing over 2 months |
| Waiting list | No intervention | –No intervention during the study duration. However, after the end of the study, after the last evaluations, participants in this control cluster will be offered the opportunity to follow the stress management programme. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Having a caring relationship with residents (e.g. nurses, nursing assistants)
- Working in the specialised care unit of the nursing home
- Working in the nursing home for at least 3 months on the date of inclusion and whose employment contract does not end within 3 months of the date of inclusion.
- Obtaining express written informed consent, after a period of reflection
Key exclusion criteria (6 listed)
- Person in a period of relative exclusion in relation to another protocol
- Person who is not affiliated to or does not benefit from a social security scheme.
- Pregnant or lactating woman
- Participant unable to give consent
- Person deprived of liberty by judicial or administrative decision
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 |
|---|---|---|
| Stress managementTen-hour, three-course stress management programme with a psychologist via video conferencing over a 2 month period. The classes will be delivered in small groups of maximum seven care workers. Carers can be brought together in the same room, but the speaker will necessarily be at a distance, via videoconferencing. The formation will adress the following issues: i) Understanding the mechanisms of stress, ii) Identifying sources of stress and triggers, iii) Anticipate stressful situations and use their resources to prevent them, and iv) Use the most appropriate stress-reduction techniques, depending on their sensitivity. | Behavioural | Remote stress management programme |
Primary outcome
Participation rate
Time frame: From enrollment to the end of the study at 3 months
Participation rate defined as the ratio of the number of participants who completed all study visits to the number of care professionals who agreed to participate.
16 secondary outcomes
Acceptance rate
Time frame: At enrollment
Retention rate
Time frame: From enrollment to the end of the study at 3 months
Adherence
Time frame: From the beginning to the end of the study, at 3 months
Quality of the intervention
Time frame: At the end of the intervention, at 3 months
Cost of the programme
Time frame: From enrollment to the end of the study at 3 months
Heart rate variability
Time frame: Baseline and 3 months
Occupational stress
Time frame: Baseline, 2 months and 3 months
Overall stress
Time frame: Baseline, 2 months and 3 months
Job satisfaction
Time frame: Baseline, 2 months and 3 months
Risk of burn-out
Time frame: Baseline, 2 months and 3 months
Quality of life
Time frame: Baseline, 2 months and 3 months
Self-rated health
Time frame: Baseline, 2 months and 3 months
Anxiety
Time frame: Baseline, 2 months and 3 months
Perceptions of the quality of patient care
Time frame: Baseline, 2 months and 3 months
Substance use
Time frame: Baseline, 2 months and 3 months
Knowledge and mastery of stress management tools
Time frame: Baseline, 2 months and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Occupational Stress
Active, not recruiting
Online Mindfulness-Based Stress Reduction for the Mental Health of Healthcare Professionals
Occupational Stress or Workplace Stress, Burnout, Professionals
Active, not recruiting
Self-Help Plus (SH+) for Stress Reduction in Social Service Workers: A Pilot RCT
Stress, Psychological, Occupational, Stress, Psychological
Enrolling by invitation
Adaptation and Evaluation of RESTORE
Nurse, Burnout, Healthcare Workers
Enrolling by invitation
PATH to Reducing Burnout Among Peers Who Deliver Overdose Prevention Services (R33 Phase Clinical Trial)
Burnout, Secondary Trauma
Recruiting
Development & Validation of a Life Balance Program for Parents of Preschoolers: A Pilot Study
Parenting Stress, Mental Health
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.
Fariba Kabirian, MD principal investigator
France Chief Medical Officer, Clariane
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress management in people with Occupational Stress, run by GCS CIPS at 4 sites in France.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Participation rate (time frame: From enrollment to the end of the study at 3 months). 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 19 Aug 2025.