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

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.

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03745235

Acronym

MindInfCare

Enrollment

Registered

2018-11-19

Start date

2019-10-21

Completion date

2020-02-26

Last updated

2025-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychiatry, Caregivers, Mindfulness

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.

Interventions

OTHERstress reduction program based on mindfulness

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

BIOLOGICALvenipunctures

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

OTHERpsychometric 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026