Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-26 @ 4:10 AM
Study NCT ID:
NCT05026827
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-25
First Post:
2021-08-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Iyengar Yoga for Prolonged Grief Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000090382', 'term': 'Prolonged Grief Disorder'}], 'ancestors': [{'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-22', 'studyFirstSubmitDate': '2021-08-24', 'studyFirstSubmitQcDate': '2021-08-27', 'lastUpdatePostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in circulating endocannabinoid concentrations', 'timeFrame': '10 weeks', 'description': 'Change in circulating endocannabinoids from baseline to post-intervention'}], 'secondaryOutcomes': [{'measure': 'Change in neural activity measured using Functional magnetic resonance imaging (fMRI)', 'timeFrame': '10 weeks', 'description': 'Change in neural activity from baseline to post-intervention'}, {'measure': 'Inventory of Complicated Grief (ICG) scale score change', 'timeFrame': '10 weeks', 'description': 'ICG score ranges from 0 to 76 (higher scores indicate worse outcome)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prolonged Grief Disorder']}, 'descriptionModule': {'briefSummary': 'Experiencing the death of a loved one is inevitable for older adults. Before the coronavirus disease 2019 (COVID-19) pandemic, over 2.5 million people died annually in the United States, including 52,000 in Wisconsin alone, and COVID-19 has added to this toll. Each person who dies leaves an average of five grieving people behind. Most grieving older adults are resilient and recover their pre-loss functioning within one year. However, in about 10%, acute grief becomes protracted and debilitating, leading to the development of prolonged grief disorder (PGD), a clinically diagnosable mental health condition. PGD in older adults increases the risk for poorer medical, mental health, and cognitive outcomes; lower quality of life; disability; premature mortality; and suicide. Despite the magnitude of this problem, the neurobiology of PGD in older adults is poorly understood. By using Iyengar Yoga (IY) as a probe for PGD neurobiology, this pilot project aims to address this critical gap.', 'detailedDescription': 'Our goal is to conduct a pilot study to examine in PGD the modulating effects of 10-week IY on circulating endocannabinoid and emotion processing brain circuit, and the associations between biological changes and clinical response.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female greater than or equal to 40 years of age\n* Bereavement \\>6 months\n* Score greater than or equal to 25 on the Inventory of Complicated Grief (ICG)\n* Presence of PGD (subsyndromal and syndromal)\n* Adequate visual and auditory acuity\n\nExclusion Criteria:\n\n* Delirium/unstable medical conditions\n* Lifetime history of neurological illnesses: seizures, stroke, dementia of any etiology, severe head injury, brain tumor or surgery\n* Serious back, joint or neck injuries within the past 3 months\n* Currently practicing yoga\n* Gross structural abnormalities on T1-weighted images\n* Lifetime history of the following psychiatric disorders: bipolar or psychotic disorders, including psychotic depression\n* Current alcohol/drug abuse or dependence\n* Magnetic resonance imaging (MRI) contraindications\n* Acute suicidality'}, 'identificationModule': {'nctId': 'NCT05026827', 'acronym': 'Yoga', 'briefTitle': 'Iyengar Yoga for Prolonged Grief Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Medical College of Wisconsin'}, 'officialTitle': 'Iyengar Yoga as a Probe of Prolonged Grief Disorder Neurobiology', 'orgStudyIdInfo': {'id': '00003864'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Iyengar Yoga', 'description': 'Participants will engage in 10 weekly IY classes', 'interventionNames': ['Other: Iyengar Yoga']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Socialization Control', 'description': 'Participants will engage in 10 weekly socialization control group sessions', 'interventionNames': ['Other: Socialization Control']}, {'type': 'NO_INTERVENTION', 'label': 'Healthy Comparison Group', 'description': 'A group of participants will also be followed for 10 weeks'}], 'interventions': [{'name': 'Iyengar Yoga', 'type': 'OTHER', 'description': 'Participation in Iyengar Yoga classes', 'armGroupLabels': ['Iyengar Yoga']}, {'name': 'Socialization Control', 'type': 'OTHER', 'description': 'Participation in socialization control group sessions', 'armGroupLabels': ['Socialization Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53226', 'city': 'Wauwatosa', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.04946, 'lon': -88.00759}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical College of Wisconsin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Joseph Goveas', 'investigatorAffiliation': 'Medical College of Wisconsin'}}}}