NCT03745235

Brief 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 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

November 19, 2018

Completed
11 months until next milestone

Study Start

First participant enrolled

October 21, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2020

Completed
Last Updated

September 24, 2025

Status Verified

September 1, 2025

Enrollment Period

4 months

First QC Date

October 25, 2018

Last Update Submit

September 19, 2025

Conditions

PsychiatryCaregiversMindfulness

Outcome Measures

Primary Outcomes (3)

  • measurement of inflammation by analysis of US-CRP blood levels

    Change from Baseline US-CRP blood levels at 3 and 12 months

  • measurement of inflammation by analysis of IL-6 blood levels

    Change from Baseline IL-6 blood levels at 3 and 12 months

  • measurement of lymphocyte activity Th1 Th2 Th17 Treg

    Change from Baseline lymphocytes activity Th1 Th2 Th17 Treg at 3 and 12 months

Study Arms (2)

"Mindfulness" group

EXPERIMENTAL
Other: stress reduction program based on mindfulnessBiological: venipuncturesOther: psychometric questionnaires

Control group

OTHER

Treatment as Usual

Biological: venipuncturesOther: psychometric questionnaires

Interventions

stress reduction program based on mindfulnessOTHER

a two and a half hour session per week for 8 weeks

"Mindfulness" group
venipuncturesBIOLOGICAL

1 dry tube of 5 ml and 5 heparinized tubes of 6 ml taken at inclusion, at 3 months and at 12 months

"Mindfulness" groupControl group
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

"Mindfulness" groupControl group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Dijon Bourogne

Dijon, 21000, France

Location

MeSH Terms

Interventions

Phlebotomy

Intervention Hierarchy (Ancestors)

Blood Specimen CollectionSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesTherapeuticsSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2018

First Posted

November 19, 2018

Study Start

October 21, 2019

Primary Completion

February 26, 2020

Study Completion

February 26, 2020

Last Updated

September 24, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)