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
NCT ID: NCT03745235
Last Updated: 2025-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
27 participants
INTERVENTIONAL
2019-10-21
2020-02-26
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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"Mindfulness" group
stress reduction program based on mindfulness
a two and a half hour session per week for 8 weeks
venipunctures
1 dry tube of 5 ml and 5 heparinized tubes of 6 ml taken at inclusion, at 3 months and at 12 months
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
Control group
Treatment as Usual
venipunctures
1 dry tube of 5 ml and 5 heparinized tubes of 6 ml taken at inclusion, at 3 months and at 12 months
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
Interventions
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stress reduction program based on mindfulness
a two and a half hour session per week for 8 weeks
venipunctures
1 dry tube of 5 ml and 5 heparinized tubes of 6 ml taken at inclusion, at 3 months and at 12 months
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
Eligibility Criteria
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Inclusion Criteria
* adult patient
* a caregiver of a person with a severe psychiatric disorder (schizophrenia, recurrent depression, bipolar disorder, obsessive-compulsive disorder)
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire Dijon
OTHER
Responsible Party
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Locations
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Chu Dijon Bourogne
Dijon, , France
Countries
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Other Identifiers
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Chauvet-Gelinier UNAFAM 2017
Identifier Type: -
Identifier Source: org_study_id
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