8-week mindfulness program for adults with prolonged grief disorder

Coping After Loss Through Mindfulness Training in Grieving Adults With Prolonged Grief Disorder - A Neuroimaging Pilot Study

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: University Hospital, Caen (Academic / other)
• Locations: 1 site (Caen, Calvados)
• Trial ID: NCT06017765 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Caen, Calvados

• 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

Conditions Prolonged Grief Disorder; Bereavement; Mindfulness Training; Script-driven Imagery; Stress Reactivity; Neuroimaging