Coping After Loss Through Mindfulness in Adults With Prolonged Grief Disorder

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity Hospital, Caen

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Meditation Training
  • Waitlist

Treatment groups

30 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University Hospital, Caen

Lead sponsor

Northeastern University

Collaborator

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

Collaborator

Cyceron

Collaborator

Université de Caen Normandie

Collaborator