Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
NCT06017765

Coping After Loss Through Mindfulness in Adults With Prolonged Grief Disorder

Led by University Hospital, Caen · Updated on 2025-07-24

30

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

Sponsors

U

University Hospital, Caen

Lead Sponsor

N

Northeastern University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Coping After Loss Through Mindfulness in Adults With Prolonged Grief Disorder

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Lost a loved one (spouse, romantic partner, parent, child, sibling, or close friend)
  • Score greater than 29 on the Inventory of Complicated Grief (ICG)
  • Clinical diagnosis of Prolonged Grief Disorder by Structured Clinical Interview for Complicated Grief (SCI-CG)
Not Eligible

You will not qualify if you...

  • Lifetime diagnosis of schizophrenia
  • Lifetime diagnosis of bipolar disorder
  • Lifetime diagnosis of psychotic disorder
  • Substance or alcohol use disorder within past 12 months
  • History of neurologic disease, seizures, stroke, or head injury with prolonged loss of consciousness or neurological effects
  • Current pregnancy or lack of approved birth control for women of childbearing age
  • Practiced mind-body techniques at least once a week in past 3 months
  • Currently undergoing psychotherapy for grief
  • Left-handedness
  • Use of medications affecting brain metabolism
  • Contraindications to MRI
  • Under legal guardianship

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

CHU de Caen et Université de Caen Normandie - Centre Esquirol Adult Psychiatry

Caen, Calvados, France, 14000

Actively Recruiting

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Research Team

B

BUI

CONTACT

A

Annick Haelewyn-Razafimandimby, Associate Pr

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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