MindInfCare: 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

• Sponsor: Centre Hospitalier Universitaire Dijon (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03745235
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 59.4
• Patients Per Site Per Month: 1.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Psychiatry; Caregivers; Mindfulness	Other: stress reduction program based on mindfulness; Biological: venipunctures; Other: psychometric questionnaires	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• 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.
• Actual Study Start Date: Oct 21, 2019
• Anticipated Primary Completion Date: Oct 1, 2024
• Anticipated Study Completion Date: Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: "Mindfulness" group	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
Other: Control group Treatment as Usual	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

Outcome Measures

Primary Outcome Measures

1. measurement of inflammation by analysis of US-CRP blood levels [Change from Baseline US-CRP blood levels at 3 and 12 months]

2. measurement of inflammation by analysis of IL-6 blood levels [Change from Baseline IL-6 blood levels at 3 and 12 months]

3. measurement of lymphocyte activity Th1 Th2 Th17 Treg [Change from Baseline lymphocytes activity Th1 Th2 Th17 Treg at 3 and 12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chu Dijon Bourogne	Dijon		France	21000

Sponsors and Collaborators

• Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire Dijon
• ClinicalTrials.gov Identifier: NCT03745235
• Other Study ID Numbers: Chauvet-Gelinier UNAFAM 2017
• First Posted: Nov 19, 2018
• Last Update Posted: May 19, 2021
• Last Verified: May 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Inflammation; Mental Disorders; Problem Behavior; Stress, Psychological

Study Results

No Results Posted as of May 19, 2021