Iyengar Yoga for Prolonged Grief Disorder

Not Applicable

Active, not recruiting

• Conditions: Prolonged Grief Disorder
• Interventions: Other: Iyengar Yoga; Other: Socialization Control

• Registration Number: NCT05026827
• Lead Sponsor: Medical College of Wisconsin

Brief 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.

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 Timeline

• Study First Submitted: 2021-08-24
• Study First Submitted QC: 2021-08-27
• Study First Posted: 2021-08-30
• Study Start: 2021-10-31
• Status Verified: 2024-10
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-18
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 68

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Iyengar Yoga	Iyengar Yoga	Participants will engage in 10 weekly IY classes
Socialization Control	Socialization Control	Participants will engage in 10 weekly socialization control group sessions

Primary Outcome Measures

Name	Time	Method
Change in circulating endocannabinoid concentrations	10 weeks	Change in circulating endocannabinoids from baseline to post-intervention

Secondary Outcome Measures

Name	Time	Method
Change in neural activity measured using Functional magnetic resonance imaging (fMRI)	10 weeks	Change in neural activity from baseline to post-intervention
Inventory of Complicated Grief (ICG) scale score change	10 weeks	ICG score ranges from 0 to 76 (higher scores indicate worse outcome)

Trial Locations

Locations (1)

Medical College of Wisconsin; 🇺🇸 Wauwatosa, Wisconsin, United States