- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05026827
Iyengar Yoga for Prolonged Grief Disorder (Yoga)
January 9, 2026 updated by: Joseph Goveas, Medical College of Wisconsin
Iyengar Yoga as a Probe of Prolonged Grief Disorder Neurobiology
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
68
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Wisconsin
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Wauwatosa, Wisconsin, United States, 53226
- Medical College of Wisconsin
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Male or female greater than or equal to 40 years of age
- Bereavement >6 months
- Score greater than or equal to 25 on the Inventory of Complicated Grief (ICG)
- Presence of PGD (subsyndromal and syndromal)
- Adequate visual and auditory acuity
Exclusion Criteria:
- Delirium/unstable medical conditions
- Lifetime history of neurological illnesses: seizures, stroke, dementia of any etiology, severe head injury, brain tumor or surgery
- Serious back, joint or neck injuries within the past 3 months
- Currently practicing yoga
- Gross structural abnormalities on T1-weighted images
- Lifetime history of the following psychiatric disorders: bipolar or psychotic disorders, including psychotic depression
- Current alcohol/drug abuse or dependence
- Magnetic resonance imaging (MRI) contraindications
- Acute suicidality
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Iyengar Yoga
Participants will engage in 10 weekly IY classes
|
Participation in Iyengar Yoga classes
|
|
Active Comparator: Socialization Control
Participants will engage in 10 weekly socialization control group sessions
|
Participation in socialization control group sessions
|
|
No Intervention: Healthy Comparison Group
A group of participants will also be followed for 10 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in circulating endocannabinoid concentrations
Time Frame: 10 weeks
|
Change in circulating endocannabinoids from baseline to post-intervention
|
10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in neural activity measured using Functional magnetic resonance imaging (fMRI)
Time Frame: 10 weeks
|
Change in neural activity from baseline to post-intervention
|
10 weeks
|
|
Inventory of Complicated Grief (ICG) scale score change
Time Frame: 10 weeks
|
ICG score ranges from 0 to 76 (higher scores indicate worse outcome)
|
10 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 30, 2021
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
August 24, 2021
First Submitted That Met QC Criteria
August 27, 2021
First Posted (Actual)
August 30, 2021
Study Record Updates
Last Update Posted (Estimated)
January 12, 2026
Last Update Submitted That Met QC Criteria
January 9, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00003864
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Prolonged Grief Disorder
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ISPA - Instituto Universitario de Ciencias Psicologicas...Not yet recruitingUnderstanding and Responding to Grief-Related Needs: A Differentiated Community Approach (GriefDiff)Prolonged Grief Disorder (PGD)Portugal
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Universidad Pontificia ComillasNot yet recruitingProlonged Grief Disorder (PGD)Spain
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University of PittsburghColumbia University; American Foundation for Suicide PreventionEnrolling by invitationProlonged Grief Disorder (PGD)United States
-
ISPA - Instituto Universitario de Ciencias Psicologicas...RecruitingGrief Disorder, ProlongedPortugal
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Debrot AnikCompletedProlonged Grief DisorderSwitzerland
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Uppsala UniversityCompletedProlonged Grief DisorderSweden
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Columbia UniversityNational Institute of Mental Health (NIMH); Center for Psychological ConsultationCompleted
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Rigshospitalet, DenmarkRecruitingProlonged Grief DisorderDenmark
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Universitat Jaume IRecruitingProlonged Grief DisorderSpain
-
Nova Southeastern UniversityNot yet recruiting
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