RecruitingNot Applicable

Coping After Loss Through Mindfulness in Adults With Prolonged Grief Disorder

France30 participantsStarted 2023-08-01

Plain-language 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) 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.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean change in Prolonged Grief Disorder (PGD) symptom severity from the pre-intervention baseline to the post-intervention endpoint visit.

Timeframe: Assessed during the pre-intervention baseline (week 0), post-intervention endpoint (week 8), and one-month follow-up visit (week 12).

Trial details

NCT IDNCT06017765

SponsorUniversity Hospital, Caen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-30

Contact for this trial

BUI

023-106-4440 bui-th@chu-caen.fr

View on ClinicalTrials.gov More Prolonged Grief Disorder trials