Iyengar Yoga for Prolonged Grief Disorder

Prolonged Grief Disorder Clinical Trial

— Yoga  

Official title:

Iyengar Yoga as a Probe of Prolonged Grief Disorder Neurobiology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05026827
• Other study ID #: 00003864
• Status: Recruiting
• Phase: N/A
• Start date: October 31, 2021
• Est. completion date: December 2025

Study information

• Verified date: November 2023
• Source: Medical College of Wisconsin
• Contact: Stacy Claesges
• Phone: 414-955-8970
• Email: sclaesge[@]mcw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Male or female greater than or equal to 40 years of age
• Bereavement >6 months
• Score >25 on the Inventory of Complicated Grief (ICG)
• Presence of PGD
• 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

Related Conditions & MeSH terms

• Prolonged Grief Disorder

Intervention

Other:
• Iyengar Yoga
Participation in Iyengar Yoga classes
• Socialization Control
Participation in socialization control group sessions

Locations

Country	Name	City	State
United States	Medical College of Wisconsin	Wauwatosa	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in circulating endocannabinoid concentrations	Change in circulating endocannabinoids from baseline to post-intervention	10 weeks
Secondary	Change in neural activity measured using Functional magnetic resonance imaging (fMRI)	Change in neural activity from baseline to post-intervention	10 weeks
Secondary	Inventory of Complicated Grief (ICG) scale score change	ICG score ranges from 0 to 76 (higher scores indicate worse outcome)	10 weeks