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

Mindfulness Clinical Trial

— MindInfCare  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03745235
• Other study ID #: Chauvet-Gelinier UNAFAM 2017
• Status: Recruiting
• Phase: N/A
• Start date: October 21, 2019
• Est. completion date: October 2024

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire Dijon
• Contact: Jean-Christophe CHAUVET-GELINIER
• Phone: +33 3 80 29 37 69
• Email: jean-christophe.chauvet-gelinier[@]chu-dijon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Caregivers
• Inflammation
• Mental Disorders
• Mindfulness
• Problem Behavior
• Psychiatry
• Stress, Psychological

Intervention

Other:
• stress reduction program based on mindfulness
a two and a half hour session per week for 8 weeks

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

Other:
• 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

Locations

Country	Name	City	State
France	Chu Dijon Bourogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measurement of inflammation by analysis of US-CRP blood levels		Change from Baseline US-CRP blood levels at 3 and 12 months
Primary	measurement of inflammation by analysis of IL-6 blood levels		Change from Baseline IL-6 blood levels at 3 and 12 months
Primary	measurement of lymphocyte activity Th1 Th2 Th17 Treg		Change from Baseline lymphocytes activity Th1 Th2 Th17 Treg at 3 and 12 months