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New treatment option for Prolonged Grief Disorder
Official title Coping After Loss Through Mindfulness in Adults With Prolonged Grief Disorder
ClinicalTrials.gov ID: NCT06017765
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- 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)
You likely can't join if
- 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...
See the full eligibility 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)
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Caen, Calvados, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Caen, Calvados, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.