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 (MindInfCare)

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.

Study Overview

• Status: Terminated
• Conditions: Mindfulness; Caregivers; Psychiatry
• Intervention / Treatment: Other: stress reduction program based on mindfulness; Biological: venipunctures; Other: psychometric questionnaires

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21000
    • Chu Dijon Bourogne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: "Mindfulness" group	Other: stress reduction program based on mindfulness; a two and a half hour session per week for 8 weeks; Biological: venipunctures; 1 dry tube of 5 ml and 5 heparinized tubes of 6 ml taken at inclusion, at 3 months and at 12 months; Other: 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: Control group; Treatment as Usual	Biological: venipunctures; 1 dry tube of 5 ml and 5 heparinized tubes of 6 ml taken at inclusion, at 3 months and at 12 months; Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2019
• Primary Completion (Actual): February 26, 2020
• Study Completion (Actual): February 26, 2020

Study Registration Dates

• First Submitted: October 25, 2018
• First Submitted That Met QC Criteria: November 15, 2018
• First Posted (Actual): November 19, 2018

Study Record Updates

• Last Update Posted (Estimated): September 24, 2025
• Last Update Submitted That Met QC Criteria: September 19, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Pathologic Processes; Problem Behavior; Inflammation; Stress, Psychological; Mental Disorders; Investigative Techniques; Therapeutics; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection; Phlebotomy
• Other Study ID Numbers: Chauvet-Gelinier UNAFAM 2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No