PsychiatryMindInfCareNCT03745235
A Study Comparing the Influence of a Mindfulness-based Stress Reduction Program vs. Routine Management on Psychological Variables and Biological Markers Related to Immuno-inflammation Associated With Psychological Stress in Caregivers of Patients With Severe Psychiatric Disorders
A study testing stress reduction program based on mindfulness, venipunctures and psychometric questionnaires in people with Psychiatry and Caregivers, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
The objective of this project is to study the influence of mindfulness meditation on psychological health (stress level, affects, emotions) and physical health parameters (rate of inflammatory markers in the blood, activity of white blood cells involved in immuno-inflammation) in caregivers of people with psychiatric… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychiatry, Caregivers, Mindfulness
- What is being tested?
- stress reduction program based on mindfulness, venipunctures and psychometric questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- 21 Oct 2019to 26 Feb 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient who has given oral consent
- adult patient
- a caregiver of a person with a severe psychiatric disorder (schizophrenia, recurrent depression, bipolar disorder, obsessive-compulsive disorder)
Who cannot join
- protected adult
- patient not affiliated to the national health insurance system
- pregnant, parturient or breastfeeding woman
- person suffering from a severe psychiatric disorder indicating a state of decompensated stress (with risk of associated biological inflammatory disturbances)
- person suffering from an inflammatory disease (autoimmune, infectious, neoplastic, cardio-vascular pathologies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Study Comparing the Influence of a Mindfulness-based Stress Reduction Program vs. Routine Management on Psychological Variables and Biological Markers Related to Immuno-inflammation Associated With Psychological Stress in Caregivers of Patients With Severe Psychiatric Disorders.
The objective of this project is to study the influence of mindfulness meditation on psychological health (stress level, affects, emotions) and physical health parameters (rate of inflammatory markers in the blood, activity of white blood cells involved in immuno-inflammation) in caregivers of people with psychiatric disorders. This study will provide the objective scientific data required for the development of mindfulness meditation programs for psychiatric caregivers.
80 participants will be randomly assigned to one of the following two groups:
- 40 participants in the "Mindfulness" group who will attend mindfulness meditation sessions in addition to their standard follow-up
- 40 participants in the "Control" group who will have a standard follow-up The duration of participation is 12 months and includes 3 visits and 8 mindfulness-based meditation sessions for the "Mindfulness" group.
- Conditions
- Psychiatry, Caregivers, Mindfulness
- Being tested
- stress reduction program based on mindfulness, venipunctures, psychometric questionnaires
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stress reduction program based on mindfulnessOther
a two and a half hour session per week for 8 weeks
venipuncturesBiological
1 dry tube of 5 ml and 5 heparinized tubes of 6 ml taken at inclusion, at 3 months and at 12 months
psychometric questionnairesOther
- Cohen PSS' perceived stress scale
- Beck's anxiety and depression questionnaires
- Watson's affectivity questionnaire, positive affect and negative affect schedule
- optimism questionnaire, Life Orientation Test LOT-R by Sheier and Carver
- IN-OUT DASQ dispositional affective style questionnaire
| Study group | Role | What they receive |
|---|---|---|
| "Mindfulness" group | Experimental | Not described Receives: Other: stress reduction program based on mindfulness; Biological: venipunctures; Other: psychometric questionnaires |
| Control group | Other | Treatment as Usual Receives: Biological: venipunctures; Other: psychometric questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of inflammation by analysis of US-CRP blood levels
Measured: Change from Baseline US-CRP blood levels at 3 and 12 months
measurement of inflammation by analysis of IL-6 blood levels
Measured: Change from Baseline IL-6 blood levels at 3 and 12 months
measurement of lymphocyte activity Th1 Th2 Th17 Treg
Measured: Change from Baseline lymphocytes activity Th1 Th2 Th17 Treg at 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start21 Oct 2019
- Primary completion26 Feb 2020
- Study completion26 Feb 2020
Why it stopped: because of the Covid pandemic, group meditation could not be carried out and was not repeated in the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychiatryStudies 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
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03745235
- Sponsor's protocol ID
- Chauvet-Gelinier UNAFAM 2017
- Acronym
- MindInfCare
- Status last verified
- Sep 2025
- First submitted
- 25 Oct 2018
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study Comparing the Influence of a Mindfulness-based Stress Reduction Program vs. Routine Management on Psychological Variables and Biological Markers Related to Immuno-inflammation Associated With Psychological Stress in Caregivers of Patients With Severe Psychiatric Disorders.
- ClinicalTrials.gov ID
- NCT03745235
- Acronym / sponsor ID
- MindInfCare / Chauvet-Gelinier UNAFAM 2017
- Conditions
- Psychiatry, Caregivers, Mindfulness
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: because of the Covid pandemic, group meditation could not be carried out and was not repeated in the study.
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 21 Oct 2019 (actual)
- Primary completion
- 26 Feb 2020 (actual)
- Study completion
- 26 Feb 2020 (actual)
- First posted
- 19 Nov 2018 (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 objective of this project is to study the influence of mindfulness meditation on psychological health (stress level, affects, emotions) and physical health parameters (rate of inflammatory markers in the blood, activity of white blood cells involved in immuno-inflammation) in caregivers of people with psychiatric disorders. This study will provide the objective scientific data required for the development of mindfulness meditation programs for psychiatric caregivers.
80 participants will be randomly assigned to one of the following two groups:
- 40 participants in the "Mindfulness" group who will attend mindfulness meditation sessions in addition to their standard follow-up
- 40 participants in the "Control" group who will have a standard follow-up The duration of participation is 12 months and includes 3 visits and 8 mindfulness-based meditation sessions for the "Mindfulness" group.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "Mindfulness" group | Experimental | Other: stress reduction program based on mindfulness, Biological: venipunctures, Other: psychometric questionnaires |
| Control group | Other | Biological: venipunctures, Other: psychometric questionnairesTreatment as Usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patient who has given oral consent
- adult patient
- a caregiver of a person with a severe psychiatric disorder (schizophrenia, recurrent depression, bipolar disorder, obsessive-compulsive disorder)
Key exclusion criteria (5 listed)
- protected adult
- patient not affiliated to the national health insurance system
- pregnant, parturient or breastfeeding woman
- person suffering from a severe psychiatric disorder indicating a state of decompensated stress (with risk of associated biological inflammatory disturbances)
- person suffering from an inflammatory disease (autoimmune, infectious, neoplastic, cardio-vascular pathologies
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 reduction program based on mindfulnessa two and a half hour session per week for 8 weeks | Other | "Mindfulness" group |
| venipunctures1 dry tube of 5 ml and 5 heparinized tubes of 6 ml taken at inclusion, at 3 months and at 12 months | Biological | "Mindfulness" group, Control group |
| psychometric questionnaires* Cohen PSS' perceived stress scale * Beck's anxiety and depression questionnaires * Watson's affectivity questionnaire, positive affect and negative affect schedule * optimism questionnaire, Life Orientation Test LOT-R by Sheier and Carver * IN-OUT DASQ dispositional affective style questionnaire | Other | "Mindfulness" group, Control group |
Primary outcome
measurement of inflammation by analysis of US-CRP blood levels
Time frame: Change from Baseline US-CRP blood levels at 3 and 12 months
measurement of inflammation by analysis of IL-6 blood levels
Time frame: Change from Baseline IL-6 blood levels at 3 and 12 months
measurement of lymphocyte activity Th1 Th2 Th17 Treg
Time frame: Change from Baseline lymphocytes activity Th1 Th2 Th17 Treg at 3 and 12 months
Results and safety
The study was stopped early (reason given: because of the Covid pandemic, group meditation could not be carried out and was not repeated in the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stress reduction program based on mindfulness, venipunctures and psychometric questionnaires in people with Psychiatry and Caregivers, run by Centre Hospitalier Universitaire Dijon at 1 site 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: stopped early, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: because of the Covid pandemic, group meditation could not be carried out and was not repeated in the study.). Results are not available in the source record.
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?
measurement of inflammation by analysis of US-CRP blood levels (time frame: Change from Baseline US-CRP blood levels at 3 and 12 months). The study lists 3 primary outcomes in all. 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 24 Sep 2025.