NCT03745235

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Centre Hospitalier Universitaire Dijon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Psychiatry
• Caregivers
• Mindfulness

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-10-21
• Primary completion: 2020-02-26
• Completion: 2020-02-26
• First posted: 2018-11-19
• Last updated: 2025-09-24

Locations

1 site across 1 country: France