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)
Primary Purpose
Psychiatry, Caregivers, Mindfulness
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
stress reduction program based on mindfulness
venipunctures
psychometric questionnaires
Sponsored by
About this trial
This is an interventional other trial for Psychiatry
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
Sites / Locations
- Chu Dijon BourogneRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
"Mindfulness" group
Control group
Arm Description
Treatment as Usual
Outcomes
Primary Outcome Measures
measurement of inflammation by analysis of US-CRP blood levels
measurement of inflammation by analysis of IL-6 blood levels
measurement of lymphocyte activity Th1 Th2 Th17 Treg
Secondary Outcome Measures
Full Information
NCT ID
NCT03745235
First Posted
October 25, 2018
Last Updated
May 18, 2021
Sponsor
Centre Hospitalier Universitaire Dijon
1. Study Identification
Unique Protocol Identification Number
NCT03745235
Brief Title
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
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 21, 2019 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychiatry, Caregivers, Mindfulness
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
"Mindfulness" group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Other
Arm Description
Treatment as Usual
Intervention Type
Other
Intervention Name(s)
stress reduction program based on mindfulness
Intervention Description
a two and a half hour session per week for 8 weeks
Intervention Type
Biological
Intervention Name(s)
venipunctures
Intervention Description
1 dry tube of 5 ml and 5 heparinized tubes of 6 ml taken at inclusion, at 3 months and at 12 months
Intervention Type
Other
Intervention Name(s)
psychometric questionnaires
Intervention Description
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
Primary Outcome Measure Information:
Title
measurement of inflammation by analysis of US-CRP blood levels
Time Frame
Change from Baseline US-CRP blood levels at 3 and 12 months
Title
measurement of inflammation by analysis of IL-6 blood levels
Time Frame
Change from Baseline IL-6 blood levels at 3 and 12 months
Title
measurement of lymphocyte activity Th1 Th2 Th17 Treg
Time Frame
Change from Baseline lymphocytes activity Th1 Th2 Th17 Treg at 3 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Christophe CHAUVET-GELINIER
Phone
+33 3 80 29 37 69
Email
jean-christophe.chauvet-gelinier@chu-dijon.fr
Facility Information:
Facility Name
Chu Dijon Bourogne
City
Dijon
ZIP/Postal Code
21000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Christophe CHAUVET-GELINIER, MD
Phone
+33 3 80 29 37 69
Email
jean-christophe.chauvet-gelinier@chu-dijon.fr
First Name & Middle Initial & Last Name & Degree
Emmanuel HAFFEN, MD
Phone
+33 3 81 21 81 54
Email
emmanuel.haffen@univ-fcomte.fr
12. IPD Sharing Statement
Learn more about this trial
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
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