[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prolonged-grief-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prolonged-grief-disorder":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,49,79,108],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100571748","early-phase-1-psilocybin-for-prolonged-grief-disorder-100571748",false,"NCT06724289","Psilocybin for Prolonged Grief Disorder","Psilocybin-Assisted Therapy for Prolonged Grief","Inclusion Criteria:\n\n* Ages 18 years old up to and including 65 years of age\n* Negative UDS results for illicit drugs at screening and prior to each drug administration session\n* Consent to all study procedures\n* Have an existing diagnosis of Prolonged Grief Disorder. May also be determined to have Complicated Grief Disorder without official diagnosis as determined by PI or designate based on DSM V criteria\n* Score of greater than 25 on the Inventory of Complicated Grief\n* Agree to abstain from any psychoactive drugs on the day prior to and the day of the drug administration session\n* People of childbearing potential that are sexually active must agree to continue or initiate practice of a highly effective means of birth control, alone or in combination with another, throughout the study. Highly effective options are: implants, intrauterine devices (IUD), and sterilization. Exclusive use of condoms is not effective.\n* Be judged by study team clinicians to be at low risk for suicidality as determined by MINI, Columbia Suicide Severity Scale, and the Patient Health Questionnaire-9.\n* Concurrent psychotherapy or pharmacotherapy with SSRIs, SNRIs, and\u002For bupropion (\\\u003C 300 mg bupropion) is allowed if the type and frequency of the therapy has been stable for at least two months prior to screening and is expected to remain stable during participation in the study\n* Be otherwise medically stable as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), urine beta-HCG, and urine toxicology screen\n* Participant must agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that they consume on a usual morning, before arriving at the research unit on the mornings of drug session days. If the participant does not routinely consume caffeinated beverages, they must agree not to do so on session days\n* Agree not to take any PRN medications on the mornings of drug sessions\n* Agree not to take sildenafil (Viagra®), tadalafil, or similar medications within 72 hours of each drug administration\n* Agree that for one week before each drug session, participant will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except when approved by the study investigators. Exceptions will be evaluated by the study investigators and will include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals\n* Willingness and ability to remain within the observation room for the duration of the study visits up to 10 hours\n* Willingness and ability to follow study protocol as directed by research staff\n* Willing and able to attend all sessions in the study and complete follow up assessments\n* Fluent in English\n* Ability to provide one photo of a deceased loved one and one photo of a living loved one, as required for the grief elicitation task.\n\nExclusion Criteria:\n\nGeneral medical exclusion criteria:\n\n* Previous use of a psychedelic drug may be exclusionary depending on frequency, context, and participant safety as determined by the PI or designate.\n* Person who is pregnant, nursing, or planning to get pregnant determined at screening and before drug session by urine test or self-report\n* People of childbearing potential that are sexually active who are not practicing an effective means of birth control\n* Cardiovascular conditions: coronary artery disease, stroke, angina, a clinically significant ECG abnormality (e.g., atrial fibrillation), prolonged QTc interval (i.e., QTc \\> 450 msec), heart valve, or TIA in the past year.\n* History of head trauma with neurological deficit; seizures, or neurologic disorders including cerebrovascular disease, epilepsy, or neurogenerative diseases\n* Type 1 diabetes\n* BMI \\\u003C18\n* Currently taking on a regular (e.g., daily) basis any antidepressant medications other than SSRIs, SNRIs, or bupropion, or any other medications that have a primary centrally-acting serotonergic effect, including MAOIs. Bupropion dosage must be \\\u003C 300 mg in order to be included\n* Nicotine dependence that would be incompatible with remaining in study area for the entirety of the visit\n* Prescribed or illicit use of benzodiazepines or opioids within 4 weeks prior to screening\n* Baseline blood pressure greater than 139\u002F79 (after repeat measures) unless stable with medication as determined by PI or PI designate\n* Taking any muscle relaxers, antihistamines, or other medications known to cause lethargy or impair cognitive ability within one day prior to psilocybin session\n* Serious medical comorbidity requiring medical intervention or close supervision\n* History of claustrophobia\n* Any court mandated or legal restrictions that would impair the participant from attending all visits\n* Inability to follow and comply with all study procedures\n* Deemed unable to meaningfully or safely participate in the study\n* Any legal judgement toward subject determined to interfere with study attendance or jeopardize compliance with study protocol determined by PI or designate\n* Individuals who are unable to undergo MRI as determined by MRI pre-screening.\n\nGeneral psychiatric exclusion criteria:\n\n* Score of less than 25 on the Inventory of Complicated Grief\n* Severe psychiatric disorder (other than depression) within 6 months or lifetime history of serious psychiatric or neurological disorders, including bipolar disorder, or active psychosis\n* Clinically significant suicidal ideation (e.g., with strong intent or means) within past 6 months or lifetime history of suicide attempt based on the MINI, Patient Health Questionnaire-9 or Columbia-Suicide Severity Scale. At any point during the study, a participant may be withdrawn from the study for concerns of suicidality and provided follow-up care by our team or a referral to care if needed.\n* Current or past history of meeting DSM-5 criteria for schizophrenia spectrum or other psychotic disorders, or bipolar I disorder\n* Current or previous history within one year of meeting DSM-5 criteria for a moderate or severe alcohol, or other drug use disorder (excluding tobacco, caffeine, and cannabis)\n* Nicotine dependence that would be incompatible with an individual to be nicotine free for 8-10 hours on a psilocybin session day\n* Have a first degree relative with schizophrenia or other psychotic disorders (except substance\u002Fmedication-induced or due to another medical condition), or bipolar I disorder",true,"ALL","18 Years","65 Years",{"count":21,"type":22},12,"ESTIMATED","INTERVENTIONAL",[25],"EARLY_PHASE1","The primary purpose of this study is to explore the feasibility of conducting a clinical trial on the effects of psilocybin for individuals with prolonged grief disorder (PGD).",[28],"Prolonged Grief Disorder",[30,31,32,33,34,35],"prolonged grief disorder","psilocybin","psychedlic-assisted treatment","psilocybin-assisted therapy","grief","grief disorder","RECRUITING","2026-06-18",{"date":39,"type":40},"2026-06-23","ACTUAL",{"date":42,"type":40},"2026-03-24",{"date":44,"type":22},"2027-08",{"name":46,"class":47},"University of Virginia","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":62,"conditions":63,"keywords":64,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":48},"100517455","coping-after-loss-through-mindfulness-in-adults-with-prolonged-grief-disorder-100517455","NCT06017765","Coping After Loss Through Mindfulness in Adults With Prolonged Grief Disorder","Coping After Loss Through Mindfulness Training in Grieving Adults With Prolonged Grief Disorder - A Neuroimaging Pilot Study","CALM-NiPS","Inclusion Criteria:\n\n* Must have lost a loved one (spouse, romantic partner, parent, child, sibling, close friend)\n* Must have a score \\>29 on the Inventory of Complicated Grief (ICG)\n* Clinical diagnosis of Prolonged Grief Disorder as assessed by the Structured Clinical Interview for Complicated Grief (SCI-CG)\n\nExclusion Criteria:\n\n* History of a lifetime clinical diagnosis of schizophrenia\n* History of a lifetime clinical diagnosis of bipolar disorder\n* History of a lifetime clinical diagnosis of a psychotic disorder\n* Current diagnosis of substance or alcohol use disorder within the past 12 months\n* History of a neurologic disease, seizures, stroke or head injury resulting in prolonged loss of consciousness and\u002For neurological sequelae\n* 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\n* Currently practice of mind-body techniques at least once a week (e.g., yoga) in the past 3 months\n* Currently undergoing concomitant psychotherapy for grief (any psychotherapy)\n* Left-handedness\n* Current use of medications that would affect cerebral metabolism\n* Any contraindications to Magnetic Resonance Imaging (MRI)\n* Being under legal guardianship","60 Years",{"count":59,"type":22},30,[61],"NA","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.\n\nThe main questions it aims to answer are:\n\n1. What is the effectiveness of Mindfulness Training to lower PGD symptom severity?\n2. What is the effectiveness of Mindfulness Training on physiological and neuroimaging biomarkers of stress reactivity?\n3. What are the potential mechanisms of treatment change of Mindfulness Training?\n\nParticipants will be:\n\n* randomly assigned to immediately receiving an 8-week Mindfulness Training program or after a 12-week waitlist.\n* 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.\n* 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).\n\nResearchers 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.",[28],[28,65,66,67,68,69],"Bereavement","Mindfulness Training","Script-driven Imagery","Stress Reactivity","Neuroimaging","2025-07-21",{"date":72,"type":40},"2025-07-24",{"date":74,"type":40},"2023-08-01",{"date":76,"type":22},"2026-07-31",{"name":78,"class":47},"University Hospital, Caen",{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":23,"phases":88,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":48},"100589375","transcranial-magnetic-stimulation-to-treat-prolonged-grief-disorder-100589375","NCT06953596","Transcranial Magnetic Stimulation to Treat Prolonged Grief Disorder","Transcranial Magnetic Stimulation to Treat Prolonged Grief Disorder: A Single-centre, Single-arm, Open-label Phase I\u002FII Proof-of-concept and Feasibility Clinical Trial","Inclusion Criteria:\n\n1. Bereaved individuals \\>\u002F= 18 years of age\n2. Score \\>25 on the Inventory of Complicated Grief\n3. Must have a primary care physician\n4. Ability to understand and communicate in English\n5. Ability to provide first-person informed consent\n\nExclusion Criteria:\n\n1. Current or previously diagnosed seizure disorder\n2. Documented brain lesions\n3. Contraindications to TMS (i.e., metallic skull plates, clips, stimulators, pacemakers)\n4. Current substance abuse disorder (e.g., schizophrenia)\n5. Pregnancy or lactation, or trying to conceive\n6. Advanced, incurable illness with an expected prognosis of \\\u003C3 months - bereaved family members are known to be at elevated risk of death from medical illness, but if death is expected in the near future, it would be difficult to justify using an entire week of their limited time for an unproven therapy.",{"count":87,"type":22},15,[61],"Grief is a normal response after the death of a loved one. With time, the grief response decreases and people learn to cope with their loss. However, for some, the response becomes more intense and distressing. This is called prolonged grief disorder (PGD). People with PGD experience emotional pain and a deep longing for their loved one. PGD normally occurs \\\u003C10% of people after a loss, but it has become more common since the COVID-19 pandemic (\\~30%). If left untreated, PGD leads to poor quality of life and increased risk of death. Treatment options such as medication and therapy are available; however, they can cause negative side effects and take a long time to work. To help individuals with PGD, we need treatments that work well and quickly.\n\nRepetitive transcranial magnetic stimulation (rTMS) is a safe, non-invasive treatment that delivers magnetic pulses to brain areas responsible for mood. rTMS has been approved in Canada to treat mood disorders. There is research to show that rTMS is safe and well-tolerated, and that works well in treating Post-Traumatic Stress Disorder (PTSD), a condition with similar symptoms to PGD. To determine whether rTMS is effective for treating PGD, we first need to determine if rTMS as a treatment for PGD is safe and feasible among grieving individuals.",[28,91],"Complicated Grief",[93,94,65,95,96,97],"Neuromodulation","Repetitive Transcranial Magnetic Stimulation","Proof-of-Concept","Feasibility","Intermittent Theta Burst Stimulation (iTBS)","NOT_YET_RECRUITING","2025-04-29",{"date":101,"type":40},"2025-05-01",{"date":103,"type":22},"2025-07-01",{"date":105,"type":22},"2026-04-30",{"name":107,"class":47},"Bruyère Health Research Institute.",{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":23,"phases":117,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":128},"100567398","a-swedish-internet-cbt-for-prolonged-grief-disorder-a-three-armed-rct-100567398","NCT06667674","A Swedish Internet CBT for Prolonged Grief Disorder: a Three-armed RCT","Efficacy and Mechanisms of Change of Online Cognitive Behavioural Therapy for Prolonged Grief Disorder After Loss: a Three-armed Randomised Control Trial","Inclusion Criteria:\n\n* Currently residing in Sweden\n* Lost a relative or close friend to any cause of death at least six months ago\n* Suffers from prolonged grief disorder\n\nExclusion Criteria:\n\n* Ongoing severe psychiatric problems that may prevent treatment implementation or require more urgent care (e.g., participants with untreated psychotic disorder, untreated bipolar disorder, ongoing substance abuse, elevated suicide risk)\n* Change in dosage of any medication for mental health issues (e.g., antidepressant medication) in the past four weeks or in the next two months",{"count":116,"type":22},270,[61],"The goal of this clinical trial is to evaluate the effectiveness of internet-delivered Cognitive Behavioral Therapy (iCBT) in reducing symptoms of prolonged grief in adults diagnosed with prolonged grief disorder.\n\nThe main questions the study aims to answer are:\n\n* Does iCBT reduce symptoms of prolonged grief disorder, posttraumatic stress, and depression following the death of a loved one in the short and long term?\n* What mechanisms contribute to the effectiveness of iCBT in treating prolonged grief disorder?\n\nThe iCBT intervention will be compared to a waitlist control group and an active control group to see if iCBT reduces symptoms of prolonged grief disorder more effectively than no treatment or a placebo treatment.\n\nParticipants will:\n\n* Be randomly assigned to either the iCBT group, an active control group or a waitlist control group\n* Complete online assessments of symptom severity, grief cognitions, and level of avoidance before, during and after intervention\n* Engage in 10 weeks of a therapist-guided online treatment",[28],"2025-04-24",{"date":99,"type":40},{"date":123,"type":40},"2025-04-23",{"date":125,"type":22},"2028-07",{"name":127,"class":47},"Uppsala University",2]