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Mental Health IssuePROMINDNCT06331065

Promoting Mental Health at Work Among Hospital Professionals

A study testing Information session on mindfulness meditation and questionnaires and Mindfulness meditation experimentation, practice program, questionnaires, individual interview and focus group in people with Mental Health Issue, run by Hospices Civils de Lyon at 8 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Mental health is a state of well-being in which a person can realize his/her potential, cope with the normal stresses of life, work productively and contribute to his/her community. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Mental Health Issue
What is being tested?
Information session on mindfulness meditation and questionnaires and Mindfulness meditation experimentation, practice program, questionnaires, individual interview and focus group
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
8 sitesFrance
Study dates
30 May 2024to 30 Jun 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

  • Being a Hospices Civils de Lyon professional working in a department participating in the project
  • Being of legal age
  • Having given written consent including voice recording for focus groups and semi-structured interviews

Who cannot join

  • Self-reported neuro-psychiatric pathology with current severe clinical instability
  • Adults under legal protection (guardianship, curators)
  • Persons not affiliated to a social security scheme or beneficiaries of a similar scheme
  • Persons unable to understand or write in French
  • Pregnant and nursing mothers

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

France8 sites
  • Neurology Department, Pierre Wertheimer Hospital (Hospices Civils de Lyon)

    Bron, 69677

  • Pediatric Intensive Care Unit - Continuous Monitoring, Femme Mère Enfant Hospital (Hospices Civils de Lyon)

    Bron, 69677

  • Department of Geriatrics, Edouard Herriot Hospital (Hospices Civils de Lyon)

    Lyon, 69003

  • Neonatology and neonatal intensive care unit, Croix-Rousse Hospital (Hospices Civils de Lyon)

    Lyon, 69004

  • Department of Anesthesia and Intensive Care, Edouard Herriot Hospital (Hospices Civils de Lyon)

    Lyon, 69437

  • Anaesthesia - Intensive Care and Perioperative Medicine Department, Lyon South Hospital (Hospices Civils de Lyon)

    Pierre-Bénite, 69495

  • Department of Physical Medicine and Neurological Rehabilitation, Henry Gabrielle Hospital (Hospices Civils de Lyon)

    Saint-Genis-Laval, 69230

  • Department of Geriatrics, Charpennes Hospital (Hospices Civils de Lyon)

    Villeurbanne, 69100

Other trials in France

About this study

Official title: Promoting Mental Health at Work Among Hospital Professionals: Implementation and Evaluation of the Effects of an Intervention Based on Mindfulness Meditation in the Workplace - PROMIND Study

Mental health is a state of well-being in which a person can realize his/her potential, cope with the normal stresses of life, work productively and contribute to his/her community. It refers to a continuum that extends from the promotion of well-being and the prevention of mental disorders to the treatment and rehabilitation of people suffering from these disorders.

Healthcare professionals face major mental health challenges, due to the demands of their profession, which is characterized by heavy workloads and confrontation with human distress. The frequency of mental health problems among hospital staff is high, at all stages (malaise, distress, pathologies). A meta-analysis found that caregivers suffer from around 30% anxiety, 30% depression, 30% psychotrauma and 45% sleep disorders.

Read more

According to the French Labor Code, employers are responsible for the physical and mental health of their employees. The Hospices Civils de Lyon establishment project includes a section on the prevention of psycho-social risks, quality of working life and management.

Healthcare professionals, like the general population, have high expectations of non-medication treatments. These non-medication interventions aim to prevent, treat, or cure a health problem. They are non-invasive and non-pharmacological, with certain observable impacts supported by scientific evidence.

Mindfulness meditation is one of the most extensively studied non-medication interventions in mental health. Declined in different modalities, its effects focus on improving resilience with efficacy on physical and mental well-being (stress, anxiety, burnout, affect), and their physiological corollary (cardiac and respiratory rhythms), acceptance of reality in stressful situations, reduced interpersonal conflict in emergencies and, more broadly, impact on relational behaviours (anti- and pro-social), teamwork. Managers also benefit, with a strengthening of the aspiration to lead, in a vision fully at the disposal of others.

Mindfulness meditation appears to be a practice that promotes mental well-being and could contribute to fulfilment at work.

The challenge is to offer a mindfulness meditation program in a hospital department for individual and collective benefit.

The main objective is to evaluate the evolution of psychological fulfilment in the workplace of hospital healthcare professionals in a 5-month meditation program between the baseline and the end of the program, in comparison with the evolution over the same period of a control group.

The expected outcome is to show that it is possible to implement a mindfulness meditation intervention for hospital staff in care departments, whatever their status or profession, with individual and collective benefits for mental health, psycho-social risks (stress, violence, etc.) and work organization. If it proves to be effective and acceptable, this intervention could be offered more widely within the institution and beyond.

Being tested
Information session on mindfulness meditation and questionnaires, Mindfulness meditation experimentation, practice program, questionnaires, individual interview and focus group
Keywords
mindfulness, prevention, psychological fulfilment, realistic assessment, occupational health promotion, mental health at work, pilot study, healthcare workers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Information session on mindfulness meditation and questionnairesOther

    The information session on mindfulness meditation is an information meeting on the PROMIND study opened to all hospital professionals from the 8 participating departments, i.e. the intervention and control groups.

    During this information session, it is specified that it is desirable for the non-intervention groups to maintain their usual practice (or non-practice) during the study, without starting a new practice of mindfulness meditation.

    Before this meeting, the baseline questionnaires are administered. Immediately after this time, the questionnaire on representations of mindfulness meditation is administered.

  • Mindfulness meditation experimentation, practice program, questionnaires, individual interview and focus groupDevice

    After randomization, a mindfulness meditation trial session is offered to all professionals in the intervention group follow by the questionnaire on representations of mindfulness meditation administration.

    Then, interdepartmental focus groups is conducted with leaders. The following mindfulness meditation program consists of 10 1-hour sessions within 15 days, in groups of up to 15 professionals, conducted at the participants' place and time of work, by a certified mindfulness meditation trainer with a recommended daily practice of 10-20 minutes with the possibility of a longer duration, and an audio guidance tool adapted to the study.

    After the program, and 3 months later, questionnaires are administered for both groups.

    For the intervention group, individual interviews, and inter-departmental focus groups (leaders) are carried out at the end of the intervention, and intra-departmental focus groups are conducted 3 months after the end.

Study groups in NCT06331065
Study groupRoleWhat they receive
Mindfulness meditation practice groupExperimentalGroup informed about mindfulness meditation and experimenting with an adapted program based on mindfulness meditation (intervention group).
Receives: Other: Information session on mindfulness meditation and questionnaires; Device: Mindfulness meditation experimentation, practice program, questionnaires, individual interview and focus group
Group without mindfulness meditation practiceActive comparatorGroup informed about mindfulness meditation and without experimentation of mindfulness meditation practice (control group).
Receives: Other: Information session on mindfulness meditation and questionnaires

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Psychological fulfilment at work

    Self-reported psychological fulfilment at work questionnaire for the intervention and control groups.

    13-item questionnaire validated in French. Each item is scored 1-7 (1 = strong disagreement; 7 = strongly agree), yielding a total between 13 and 91 (a high score indicating a high level of psychological fulfillment at work).

    Measured: Baseline: before the intervention and immediately after the intervention

Secondary outcomes (18)
  1. Psychological fulfilment at work

    Self-reported psychological fulfilment at work questionnaire for the intervention and control groups.

    13-item questionnaire validated in French. Each item is scored 1-7 (1 = strong disagreement; 7 = strongly agree), yielding a total between 13 and 91 (a high score indicating a high level of psychological fulfillment at work).

    Measured: 3 months immediately after the end of the intervention

  2. Mindful state

    Intervention's impact on the mindful state measured by the Five Facet Mindfulness Questionnaire (15 items) (FFMQ-15).

    Each item is scored on a 5-point Likert scale (1 = never or very rarely true; 2 = rarely true; 3 = sometimes true; 4 = often true; 5 = very often or always true).

    Higher scores mean a more mindful state.

    Measured: Baseline: before the intervention, immediately after the intervention and 3 months immediately after the intervention

  3. Aggressiveness

    Intervention's impact on aggressiveness measured by the 12-item Aggression Questionnaire (AQ12).

    Each item is scored from 1 to 6 (1 = not me at all; 6 = quite me). Higher scores mean a higher level of aggressiveness.

    Measured: Baseline: before the intervention, immediately after the intervention and 3 months immediately after the intervention

  4. Impulsivity, experience of being disturbed by conflict, and psychological safety.

    Intervention's impact on impulsivity, experience of being disturbed by conflict, patient support, and psychological safety measured by a visual analog scale (VAS).

    The VAS ranges from "not at all" (0) to "completely" (10). Higher scores mean a greater impulsivity, a greater experience of being disturbed by conflict and a greater psychological safety.

    Measured: Baseline: before the intervention, immediately after the intervention and 3 months immediately after the intervention

  5. Occupational stress

    Intervention's impact on occupational stress measured by the Job content questionnaire (26 items) Each item is scored from 1 to 4 on a 4-point Likert scale (1 = strongly disagree; 2 = disagree; 3 = agree; 4 = strongly agree).

    The higher the scores, the higher the levels of occupational stress.

    Measured: Baseline: before the intervention, immediately after the intervention and 3 months immediately after the intervention

  6. Collective activity

    Intervention's impact on collective activity ameasured with 4 items by self-assessment using a visual analog scale (VAS).

    Each item is scored from 0 to 10 (0 = strongly disagree; 10 = strongly agree). A higher score indicating greater collective activity.

    Measured: Baseline: before the intervention, immediately after the intervention and 3 months immediately after the intervention

  7. Organizational leeway

    Intervention's impact on organizational leeway measured by a a visual analog scale (VAS).

    Item 1 is scored with a 5-point VAS (always; most of the time; sometimes; rarely; never). Item 2 is score with a 4-point VAS (never; sometimes; often; always). Items 3 and 4 are scored from 0 to 5 (0 = strongly disagree; 5 = strongly agree).

    A high frequency on item 1, a low frequency on item 2, a low score on item 3 and a high score on item 4 each indicate higher organizational leeway.

    Measured: Baseline: before the intervention, immediately after the intervention and 3 months immediately after the intervention

  8. Evolution of participants' representation of mindfulness meditation

    The evolution of participants' representation of mindfulness meditation is measured by Devilly and Borkovec's adapted credibility and expectations questionnaire (6 items).

    Items 1 (I), 2 (I), 3 (I) and 1 (II) are scored from 1 to 9 (1 = not at all consistent /helpful /confident; 9 = very consistent /helpful /confident) and items 4 (I) and 2 (II) are scored from 0% to 100%. An expectancy score is provided by items 4 (I), 1 (II) and 2 (II). A credibility score is provided by items 1 (I), 2 (I), and 3 (I). Higher scores indicate higher levels of expectancy and credibility.

    Measured: Before and after the information session on mindfulness meditation, immediately after the first experimental session, immediately after the program and 3 months after the program

  9. The representation of mindfulness meditation among professionals

    Description of the representation of mindfulness meditation measured from verbatim from focus groups.

    Measured: Before the program, up to 12 months , 1 and 3 months after the end of the intervention

  10. The representation of mindfulness meditation among professionals

    Description of the representation of mindfulness meditation measured from semi-structured interviews.

    Measured: 1 and 3 months after the end of the intervention

  11. The representation of mindfulness meditation among professionals

    Description of the representation of mindfulness meditation measured from verbatim from observation reports.

    Measured: up to 12 months

  12. Fidelity and adherence to the mindfulness meditation intervention

    Assessing the number of sessions attended, participants and practices in daily life.

    Measured: At study completion, an average of 15 months

  13. Fidelity and adherence to the mindfulness meditation intervention

    Assessing the duration of the sessions

    Measured: At study completion, an average of 15 months

  14. Barriers and facilitators to the implementation

    Assessing barriers and facilitators to the implementation through verbatim from focus groups.

    Measured: At study completion, an average of 15 months

  15. Barriers and facilitators to the implementation

    Assessing barriers and facilitators to the implementation through verbatim from semi-structured interviews.

    Measured: At study completion, an average of 15 months

  16. Mechanisms of the intervention effects

    Qualitative exploration and description of intervention effects and the mechanisms by which they are produced.

    The objective and methods are open-ended, with no preconceived ideas about the effects produced by the intervention, their mechanisms, and the way in which these mechanisms may be activated (or not) depending on the implementation context. It is based on a triangulation of three complementary methods: 1- non-participant observation.

    Measured: At study completion, an average of 15 months

  17. Mechanisms of the intervention effects

    Qualitative exploration and description of intervention effects and the mechanisms by which they are produced.

    It is based on a triangulation of three complementary methods: 2- focus groups.

    Measured: At study completion, an average of 15 months

  18. Mechanisms of the intervention effects

    Qualitative exploration and description of intervention effects and the mechanisms by which they are produced.

    It is based on a triangulation of three complementary methods: 3- semi-structured individual interviews.

    Measured: At study completion, an average of 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2024
  2. Study start30 May 2024
  3. Primary completion30 Nov 2024
  4. Study completion30 Jun 2025

Resources

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
Health services research
Allocation
Not applicable
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06331065
Sponsor's protocol ID
69HCL21_1180
Other IDs
ID-RCB
Acronym
PROMIND
Status last verified
Jan 2026
First submitted
21 Feb 2024
Last updated
16 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Promoting the mental health of hospital professionals through a workplace-based mindfulness intervention: PROMIND protocol for a randomized controlled trial with a realist evaluation , 1. L. NOHALES* (1, 2), 2. S. TOUZET (1, 2), 3. A. TERMOZ (3, 4), 4. L. REMONTET (5, 6), 5. LA. AUDOUARD (1), 6. M. TROUSSELARD (7, 8), 7. E. FORT (2), 8. N. STREICHENBERGER (9, 10), 9. P. DELAMILLIEURE (11, 12), 10. A. LUTZ (13), 11. D. MAUCORT-BOULCH (5, 6), 12. JB. FASSIER (2). Manuscript under review in JMIR Research Protocols.

Questions about this trial

What is this clinical trial studying?

A study testing Information session on mindfulness meditation and questionnaires and Mindfulness meditation experimentation, practice program, questionnaires, individual interview and focus group in people with Mental Health Issue, run by Hospices Civils de Lyon at 8 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 3 inclusion and 5 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 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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?

Psychological fulfilment at work (time frame: Baseline: before the intervention and immediately after the intervention). 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 NCT06331065, 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 16 Jun 2026.

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