8-week mindfulness program for adults with prolonged grief disorder
Official title: Coping After Loss Through Mindfulness Training in Grieving Adults With Prolonged Grief Disorder - A Neuroimaging Pilot Study
Run by University Hospital, Caen · NCT06017765 · Data updated 2026-11-12
This pilot tries an 8-week mindfulness training to see if it reduces grief symptoms and lowers stress-related brain and body responses in adults aged 18–60 with prolonged grief disorder.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | University Hospital, Caen Academic / other |
| Locations | 1 site (Caen, Calvados) |
| Status | Recruiting |
| Started | August 1, 2023 |
| Main results expected | April 30, 2026 |
| Study ends | July 31, 2026 |
| Registry record updated | July 24, 2025 |
| Trial ID | NCT06017765 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–60 who have lost a close person, meet diagnostic criteria for Prolonged Grief Disorder, and score above 29 on the Inventory of Complicated Grief are ideal candidates.
✕Probably not a fit
Individuals with lifetime diagnoses of schizophrenia, bipolar disorder, psychotic disorders, recent substance or alcohol use disorder, significant neurologic disease, or current pregnancy are excluded and may not receive benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized pilot assigns adults diagnosed with Prolonged Grief Disorder to either immediate participation in an 8-week standardized mindfulness training or a 12-week waitlist control, with clinical and biomarker assessments at baseline and after the intervention. Outcomes include psychiatric and somatic symptom measures alongside physiological recordings and neuroimaging collected during bereavement-related stress tasks to quantify stress reactivity. The study also examines potential mechanisms of change by linking symptom shifts to alterations in physiological and neural markers. Standardized mindfulness sessions and scripted-imagery stress probes are used to elicit and measure bereavement-specific reactivity.
Why it matters
Potential benefit: If successful, the program could reduce prolonged grief symptoms and decrease stress-related physiological and brain responses, potentially improving mental and physical health outcomes for bereaved adults.
How similar studies have gone: Mindfulness programs have lowered general stress reactivity in healthy people and in anxiety disorders and small pilot data support benefit in grief, but bereavement-specific neurobiological effects remain largely untested.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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CHU de Caen et Université de Caen Normandie - Centre Esquirol Adult Psychiatry
Caen, Calvados, France Recruiting
Study contacts
- Principal investigator: Eric BUI, Professor — CHU de Caen, Université de Caen Normandie, INSERM U1237, PhIND
- Study coordinator: Bui
- Email: bui-th@chu-caen.fr
- Phone: 023-106-4440
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Noninvasive brain stimulation to help prolonged grief
This study tests whether repetitive transcranial magnetic stimulation (rTMS) can help adults with prolonged grief disorder who are coping poorly.
-
Psilocybin to help people with prolonged grief disorder
This study will test whether a single 25 mg dose of psilocybin can reduce grief and trauma symptoms in adults with prolonged grief disorder.
-
Internet therapy for prolonged grief disorder
This study is testing if online therapy can help adults with prolonged grief feel better after losing a loved one.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.