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)

University Hospital Center (CHU) Dijon Bourgogne

Status: Terminated

Conditions: Mindfulness; Caregivers; Psychiatry

Treatments: Other: stress reduction program based on mindfulness; Other: psychometric questionnaires; Biological: venipunctures

Study type: Interventional

Funder types: Other

Identifiers

NCT03745235

Chauvet-Gelinier UNAFAM 2017

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

"Mindfulness" group

Experimental group

Treatment:

Biological: venipunctures

Other: psychometric questionnaires

Other: stress reduction program based on mindfulness

Control group

Other group

Description:

Treatment as Usual

Treatment:

Biological: venipunctures

Other: psychometric questionnaires