Coping After Loss Through Mindfulness in Adults With Prolonged Grief Disorder
ConditionProlonged 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
This trial does not accept healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
Meditation Training
BehavioralThe 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.
Waitlist
BehavioralThe waitlist consists of a waiting time of 12 weeks during which participants will nog receive any type of intervention.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Immediate Meditation Training groupExperimental treatment 1 intervention
Group B: Waitlist Control groupOther 1 intervention
Trial outcomes
Primary outcomes
1
Mean change in Prolonged Grief Disorder (PGD) symptom severity from the pre-intervention baseline to the post-intervention endpoint visit.
PGD symptom severity is assessed by the Inventory of Complicated Grief (ICG) questionnaire.
Time frame
Assessed during the pre-intervention baseline (week 0), post-intervention endpoint (week 8), and one-month follow-up visit (week 12).Secondary outcomes
1
Mean change in Prolonged Grief Disorder (PGD) symptom severity from the pre-intervention baseline to the post-intervention endpoint, and one-month follow-up visit.
PGD symptom severity is assessed by the Structural Clinical Interview for Complicated Grief (SCI-CG).
Time frame
Assessed during the pre-intervention baseline (week 0), post-intervention endpoint (week 8), and one-month follow-up visit (week 12).2
Mean change in Posttraumatic Stress Disorder (PTSD) symptom severity in relation to the death, from the pre-intervention baseline to the post-intervention endpoint, and one-month follow-up visit.
PTSD symptom severity is assessed by the PTSD Checklist for DSM-5 (PCL-5).
Time frame
Assessed during the pre-intervention baseline (week 0), post-intervention endpoint (week 8), and one-month follow-up visit (week 12).3
Mean change in Depression symptom severity from the pre-intervention baseline to the post-intervention endpoint, and one-month follow-up visit.
Depression symptom severity is assessed by the Quick Inventory of Depressive Symptomatology (QIDS-SR).
Time frame
Assessed during the pre-intervention baseline (week 0), post-intervention endpoint (week 8), and one-month follow-up visit (week 12).4
Mean change in somatic complaints from the pre-intervention baseline to the post-intervention endpoint, and one-month follow-up visit.
Somatic symptoms are assessed by the Medical Symptom Checklist (MSCL).
Time frame
Assessed during the pre-intervention baseline (week 0), post-intervention endpoint (week 8), and one-month follow-up visit (week 12).Other outcomes
1
Characteristics of the death.
Charcteristics of the death are assessed as covariates and include the time since the loss, the type of death, the cause of death, and the relationship between the participant and the deceased.
Time frame
Assessed during the screening visit (week-4 until 0).2
The absence of diagnostic exclusion criteria and co-occurring Axis-I psychiatric disorders.
Diagnoses is assessed by the Mini International Neuropsychiatric Interview (MINI).
Time frame
Assessed during the screening visit (week-4 until 0).3
Socio-demographic variables.
Socio-demographic variables are assessed as potential Confounders for grief reactions and include age, sex, gender, socioeconomic status, educational level, racial and ethnic origins, menstrual cycle information, and handedness.
Time frame
Assessed during the screening visit (week-4 until 0).4
Self-reports of mood and bereavement-related stress responses.
Self-report mood and bereavement-related stress responses measured on 8-point Likert scales (range 0 "none" - 8 "a great deal") are assessed for vividness, valence related to control/dominance, happiness/pleasure, and excitement/ arousal of their imagery, as well as feelings of sadness, anger, fear, disgust, surprise, guilt, emotional pain and yearning for the deceased during each imagery phase of the Script-Driven Imagery paradigm in the neuroimaging scanner to check that the paradigm elicited the intended emotions.
Time frame
Assessed during each imagery phase of the Script-Driven Imagery paradigm during the pre-intervention baseline (week 0) and post-intervention endpoint visit (week 8).Sponsors and contacts
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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
Source ClinicalTrials.gov