Iyengar Yoga for Prolonged Grief Disorder

Sponsor

Medical College of Wisconsin (Other)

Overall Status

Recruiting

CT.gov ID

NCT05026827

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prolonged Grief Disorder	Other: Iyengar Yoga Other: Socialization Control	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Iyengar Yoga as a Probe of Prolonged Grief Disorder Neurobiology

Actual Study Start Date :

Oct 31, 2021

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Iyengar Yoga Participants will engage in 10 weekly IY classes	Other: Iyengar Yoga Participation in Iyengar Yoga classes
Active Comparator: Socialization Control Participants will engage in 10 weekly socialization control group sessions	Other: Socialization Control Participation in socialization control group sessions
No Intervention: Healthy Comparison Group A group of participants will also be followed for 10 weeks

Arm

Intervention/Treatment

Experimental: Iyengar Yoga

Participants will engage in 10 weekly IY classes

Other: Iyengar Yoga

Participation in Iyengar Yoga classes

Active Comparator: Socialization Control

Participants will engage in 10 weekly socialization control group sessions

Other: Socialization Control

Participation in socialization control group sessions

No Intervention: Healthy Comparison Group

A group of participants will also be followed for 10 weeks

Outcome Measures

Primary Outcome Measures

Change in circulating endocannabinoid concentrations [10 weeks]
Change in circulating endocannabinoids from baseline to post-intervention

Secondary Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Male or female between the ages of 50 and 90 years
Bereavement >12 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical College of Wisconsin	Wauwatosa	Wisconsin	United States	53226

Sponsors and Collaborators

Medical College of Wisconsin

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Joseph Goveas, Professor, Medical College of Wisconsin

ClinicalTrials.gov Identifier:

NCT05026827

Other Study ID Numbers:

00003864

First Posted:

Aug 30, 2021

Last Update Posted:

Nov 22, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Disease

Study Results

No Results Posted as of Nov 22, 2021