Coping After Loss Through Mindfulness Training in Grieving Adults With Prolonged Grief Disorder - A Neuroimaging Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Mean change in Prolonged Grief Disorder (PGD) symptom severity from the pre-intervention baseline to the post-intervention endpoint visit.
研究概览
简要总结
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:
- What is the effectiveness of Mindfulness Training to lower PGD symptom severity?
- What is the effectiveness of Mindfulness Training on physiological and neuroimaging biomarkers of stress reactivity?
- 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.
详细描述
Bereavement is a major life stressor that triggers a stress response that can last months or years after the death of a loved one. This condition of persisting grief response called Prolonged Grief Disorder (PGD) has been recently included in the World Health Organization (WHO) International Classification of Diseases, and the fifth text-revised version of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5TR). A core symptom of PGD is the heightened reactivity to reminders of the death. This stress response, if exaggerated and persisting, is associated with increased risk for mental health problems including suicide, as well as somatic problems such as cardiac adverse events. To date, no efficacious intervention for reducing a bereavement-related stress response exist to prevent the negative health outcomes of adults who lost a loved one. Mindfulness Training has shown efficacy to decrease the general stress reactivity, as was shown in healthy individuals and in anxiety disorders, supposedly by improving emotional regulation. Therefore, it has the potential to successfully target bereavement-related stress-reactivity in grievers, as supported by our pilot data. However, it is unknown whether mindfulness meditation may also decrease bereavement-specific stress reactivity, one of the core symptoms of PGD. Furthermore, little is known about the neurobiological changes that underlie the decrease in stress reactivity that results from mindfulness training.
The present proposal is the first ever clinical trial to pilot the effectiveness of an 8-week Mindfulness Training to decrease psychiatric and somatic symptoms of PGD in adult patients, as well as to pilot changes in physiological and neuroimaging biomarkers of bereavement-related stress reactivity that are associated with Mindfulness Training 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). As PGD is a newly recognized psychiatric condition, there are very limited data available about its pathophysiology and neurobiology, and in particular how treatments can intervene on it. Although mind-body interventions such as Mindfulness Training have recently shown to be effective for stress-related conditions, limited data are available about their mechanisms of actions. Our proposal is the first to examine trauma-related emotional regulation neural circuits implicated in the effects of Mindfulness Training on pathological grief reactions.
- OBJECTIVES:
This study aims to examine the effects of an 8-week standardized Mindfulness Training program on PGD symptom severity and stress reactivity, as well as to elucidate the neural mechanism of these effects, in grieving adult patients who are diagnosed with PGD.
The specific aims of this study are:
- PRIMARY AIM Aim 1. Examine the efficacy of Mindfulness Training to decrease PGD symptom severity (primary outcome) in a group of patients with PGD who will immediately receive the training versus the waitlist control group consisting of patients with PGD who are waiting on a waitlist to receive the training after the Mindfulness Training group.
- SECONDARY AIMS Aim 2. Examine the efficacy of Mindfulness Training on physiological and neuroimaging biomarkers of bereavement-related and general stress reactivity in a group of patients with PGD who will immediately receive the training versus the waitlist control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants will be assessed for psychiatric symptoms (primary objective) by blinded Independent Evaluators, who will not be involved in the mindfulness training sessions. Participants will be instructed to keep their evaluators blinded to the randomization. Blinded Independent Evaluators will be clinical psychologists who are fully trained in assessing the different measures.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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 childbearing age
- •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
结局指标
主要结局
Mean change in Prolonged Grief Disorder (PGD) symptom severity from the pre-intervention baseline to the post-intervention endpoint visit.
时间窗: Assessed during the pre-intervention baseline (week 0), post-intervention endpoint (week 8), and one-month follow-up visit (week 12).
PGD symptom severity is assessed by the Inventory of Complicated Grief (ICG) questionnaire.
次要结局
- 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.(Assessed during the pre-intervention baseline (week 0), post-intervention endpoint (week 8), and one-month follow-up visit (week 12).)
- Mean change in Depression symptom severity from the pre-intervention baseline to the post-intervention endpoint, and one-month follow-up visit.(Assessed during the pre-intervention baseline (week 0), post-intervention endpoint (week 8), and one-month follow-up visit (week 12).)
- 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.(Assessed during the pre-intervention baseline (week 0), post-intervention endpoint (week 8), and one-month follow-up visit (week 12).)
- Mean change in somatic complaints from the pre-intervention baseline to the post-intervention endpoint, and one-month follow-up visit.(Assessed during the pre-intervention baseline (week 0), post-intervention endpoint (week 8), and one-month follow-up visit (week 12).)
- Mean change in the ability to cope with stress from the pre-intervention baseline to the post-intervention endpoint, and one-month follow-up visit.(Assessed during the pre-intervention baseline (week 0), post-intervention endpoint (week 8), and one-month follow-up visit (week 12).)
- Mean change in global symptom severity from the pre-intervention baseline to the post-intervention endpoint, and one-month follow-up visit.(Assessed during the pre-intervention baseline (week 0), post-intervention endpoint (week 8), and one-month follow-up visit (week 12).)
- Mean change in heart rate responses to bereavement-related stress from the pre-intervention baseline to the post-intervention endpoint visit.(Assessed during the pre-intervention baseline (week 0) and post-intervention endpoint visit (week 8).)
- Mean change in global symptom improvement from the mid-intervention midpoint to the post-intervention endpoint, and one-month follow-up visit.(Assessed during the mid-intervention midpoint (week 4), post-intervention endpoint (week 8), and one-month follow-up visit (week 12).)
- Mean change in skin conductance response rates to bereavement-related stress from the pre-intervention baseline to the post-intervention endpoint visit.(Assessed during the pre-intervention baseline (week 0) and post-intervention endpoint visit (week 8).)
- Mean change in skin conductance response rates during general stress from the pre-intervention baseline to the post-intervention endpoint visit.(Assessed during the pre-intervention baseline (week 0) and post-intervention endpoint visit (week 8).)
- Mean change in heart rate responses to general stress from the pre-intervention baseline to the post-intervention endpoint visit.(Assessed during the pre-intervention baseline (week 0) and post-intervention endpoint visit (week 8).)
- Mean change in Blood Oxygentation Level Dependent (BOLD brain activity) signals during bereavement-related stress from the pre-intervention baseline to the post-intervention endpoint visit.(Assessed during the pre-intervention baseline (week 0) and post-intervention endpoint visit (week 8).)
- Mean change in brain Functional Connectivity during bereavement-related stress from the pre-intervention baseline to the post-intervention endpoint visit.(Assessed during the pre-intervention baseline (week 0) and post-intervention endpoint visit (week 8).)
- Mean change in Blood Oxygentation Level Dependent (BOLD brain activity) signals during general stress from the pre-intervention baseline to the post-intervention endpoint visit.(Assessed during the pre-intervention baseline (week 0) and post-intervention endpoint visit (week 8).)
- Mean change in brain Functional Connectivity during general stress from the pre-intervention baseline to the post-intervention endpoint visit.(Assessed during the pre-intervention baseline (week 0) and post-intervention endpoint visit (week 8).)