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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Psychiatry, Caregivers, Mindfulness

Intervention / Treatment
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* Other: stress reduction program based on mindfulness
* Biological: venipunctures
* Other: psychometric questionnaires


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |