Coping After Loss Through Mindfulness in Adults With Prolonged Grief Disorder

Recruiting now · Not applicable

Conditions studied: Prolonged Grief Disorder

In brief

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) and to examine changes in physiological and neuroimaging biomarkers of bereavement-related stress reactivity that are associated with Mindfulness Training in grieving adult patients (men and women, aged 18-60) who are diagnosed with PGD. The main questions it aims to answer are: 1. What is the effectiveness of Mindfulness Training to lower PGD symptom severity? 2. What is the effectiveness of Mindfulness Training on physiological and neuroimaging biomarkers of stress reactivity? 3. What are the potential mechanisms of treatment change of Mindfulness Training? Participants will be: * randomly assigned to immediately receiving an 8-week Mindfulness Training program or after a 12-week waitlist. * assessed for psychiatric and somatic symptoms and for physiological responses during a baseline, midpoint and endpoint visit, and at a one-month follow-up visit. * assessed for functional neuroimaging biomarkers of bereavement-related and general stress reactivity at the baseline and endpoint visits using a script-driven imagery task (which induces bereavement-related stress reactivity during an imagery of a personal situation related to the death compared to imagery of a neutral personal situation), and loud tones stress task (which induces general stress reactivity). Researchers will compare the Mindfulness Training group (which consists of patients with PGD who will receive the Mindfulness Training immediately) with the waitlist control group (which consists of patients with PGD who are waiting on a waitlist to receive the training after the Mindfulness Training group) to investigate if they differ in PGD symptom severity as well as physiological and neuroimaging biomarkers of stress reactivity.

Key facts

Study ID: NCT06017765
Run by: University Hospital, Caen
People needed: 30
Starts: 2023-08-01
Expected to finish: 2026-07-31
Last updated by the study team: 2025-07-24

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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)

You may not qualify if…

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

Where it is running

CHU de Caen et Université de Caen Normandie - Centre Esquirol Adult Psychiatry — Caen, Calvados, France (enrolling)

Full record on ClinicalTrials.gov

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