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

Centre Hospitalier Universitaire Dijon27 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Psychiatry Caregivers Mindfulness

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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