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

Not Applicable

Recruiting

• Conditions: Psychiatry; Caregivers; Mindfulness
• Interventions: Other: stress reduction program based on mindfulness; Biological: venipunctures; Other: psychometric questionnaires

• Registration Number: NCT03745235
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-25
• Study First Submitted QC: 2018-11-15
• Study First Posted: 2018-11-19
• Study Start: 2019-10-21
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-19
• Last Update Posted: 2024-02-20
• Primary Completion: 2024-10
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
"Mindfulness" group	stress reduction program based on mindfulness	-
"Mindfulness" group	psychometric questionnaires	-
Control group	venipunctures	Treatment as Usual
Control group	psychometric questionnaires	Treatment as Usual
"Mindfulness" group	venipunctures	-

Primary Outcome Measures

Name	Time	Method
measurement of inflammation by analysis of US-CRP blood levels	Change from Baseline US-CRP 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
measurement of inflammation by analysis of IL-6 blood levels	Change from Baseline IL-6 blood levels at 3 and 12 months

Trial Locations

Locations (1)

Chu Dijon Bourogne; 🇫🇷 Dijon, France