Status:
RECRUITING
Coping After Loss Through Mindfulness in Adults With Prolonged Grief Disorder
Lead Sponsor:
University Hospital, Caen
Collaborating Sponsors:
Northeastern University
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Prolonged Grief Disorder
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to pilot the effectiveness of an 8-week standardized Mindfulness Training program to decrease the psychiatric and somatic symptoms of prolonged grief disorder (PGD) ...
Detailed Description
Bereavement is a major life stressor that triggers a stress response that can last months or years after the death of a loved one. This condition of persisting grief response called Prolonged Grief Di...
Eligibility Criteria
Inclusion
- Must have lost a loved one (spouse, romantic partner, parent, child, sibling, close friend)
- Must have a score \>29 on the Inventory of Complicated Grief (ICG)
- Clinical diagnosis of Prolonged Grief Disorder as assessed by the Structured Clinical Interview for Complicated Grief (SCI-CG)
Exclusion
- History of a lifetime clinical diagnosis of schizophrenia
- History of a lifetime clinical diagnosis of bipolar disorder
- History of a lifetime clinical diagnosis of a psychotic disorder
- Current diagnosis of substance or alcohol use disorder within the past 12 months
- History of a neurologic disease, seizures, stroke or head injury resulting in prolonged loss of consciousness and/or neurological sequelae
- Current pregnancy as assessed by a urinary pregnancy test at screening during the Screening (week -4 until 0), Baseline (week 0) or Endpoint visit (week 8), or lack of use approved methods birth control for women of childbearing age
- Currently practice of mind-body techniques at least once a week (e.g., yoga) in the past 3 months
- Currently undergoing concomitant psychotherapy for grief (any psychotherapy)
- Left-handedness
- Current use of medications that would affect cerebral metabolism
- Any contraindications to Magnetic Resonance Imaging (MRI)
- Being under legal guardianship
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06017765
Start Date
August 1 2023
End Date
July 31 2026
Last Update
July 24 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
CHU de Caen et Université de Caen Normandie - Centre Esquirol Adult Psychiatry
Caen, Calvados, France, 14000