Clinical trial

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.

Name

Chauvet-Gelinier UNAFAM 2017

Description

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.

Trial arms

Trial start

2019-10-21

Estimated PCD

2024-10-01

Trial end

2024-10-01

Status

Recruiting

Treatment

stress reduction program based on mindfulness

a two and a half hour session per week for 8 weeks

Arms:

"Mindfulness" group

venipunctures

1 dry tube of 5 ml and 5 heparinized tubes of 6 ml taken at inclusion, at 3 months and at 12 months

Arms:

"Mindfulness" group, Control group

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

Arms:

"Mindfulness" group, Control group

Size

Primary endpoint

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

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}

Updated at

2024-02-20

1 organization

Organization

Centre Hospitalier Universitaire Dijon