Coping After Loss Through Mindfulness in Adults With Prolonged Grief Disorder

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.

Conditions

• Prolonged Grief Disorder

Interventions

BEHAVIORAL

Meditation Training

The Meditation Training consists of 8 weekly sessions of Mindfulness Training and is adapted from the group-based Stress Management and Resiliency Training - Relaxation Response Resiliency Program, SMART-3RP. This training is structured around the following four goals: 1. Education about stress response 2. Elicitation of the Relaxation Response through Mindfulness Training 3. Creating adaptive perspectives 4. Coping strategiest.

BEHAVIORAL

Waitlist

The waitlist consists of a waiting time of 12 weeks during which participants will nog receive any type of intervention.

Sponsors & Collaborators

• Northeastern University

  collaborator OTHER

• Institut National de la Santé Et de la Recherche Médicale, France

  collaborator OTHER_GOV

• Cyceron

  collaborator UNKNOWN

• Université de Caen Normandie

  collaborator OTHER

• University Hospital, Caen

  lead OTHER

Principal Investigators

• Eric BUI, Professor · CHU de Caen, Université de Caen Normandie, INSERM U1237, PhIND

• Annick Haelewyn-Razafimandimby, Associate Pr · INSERM U1237, PhIND

• Charlotte Hilberdink, Postdoc · INSERM U1237, PhIND

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-08-01

Primary Completion

2026-04-30

Completion

2026-07-31

Countries

• France

Study Locations