NCT05026827

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Aug 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Aug 2021Dec 2026

First Submitted

Initial submission to the registry

August 24, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 30, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

August 30, 2021

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

4.9 years

First QC Date

August 24, 2021

Last Update Submit

January 9, 2026

Conditions

Prolonged Grief Disorder

Outcome Measures

Primary Outcomes (1)

  • Change in circulating endocannabinoid concentrations

    Change in circulating endocannabinoids from baseline to post-intervention

    10 weeks

Secondary Outcomes (2)

  • Change in neural activity measured using Functional magnetic resonance imaging (fMRI)

    10 weeks

  • Inventory of Complicated Grief (ICG) scale score change

    10 weeks

Study Arms (3)

Iyengar Yoga

EXPERIMENTAL

Participants will engage in 10 weekly IY classes

Other: Iyengar Yoga

Socialization Control

ACTIVE COMPARATOR

Participants will engage in 10 weekly socialization control group sessions

Other: Socialization Control

Healthy Comparison Group

NO INTERVENTION

A group of participants will also be followed for 10 weeks

Interventions

Iyengar YogaOTHER

Participation in Iyengar Yoga classes

Iyengar Yoga
Socialization ControlOTHER

Participation in socialization control group sessions

Socialization Control

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical College of Wisconsin

Wauwatosa, Wisconsin, 53226, United States

Location

Related Publications (1)

  • Goveas JS, Hwang G, McAuliffe TL, Blair NP, Webber A, Claesges SA, Murphy LM, Chandler K, Reynolds CF, Hainsworth KR. Iyengar yoga and health education interventions for prolonged grief disorder in later life: feasibility of a randomized controlled pilot trial. Sci Rep. 2025 Dec 24;15(1):44604. doi: 10.1038/s41598-025-28397-5.

    PMID: 41444366DERIVED

MeSH Terms

Conditions

Prolonged Grief Disorder

Condition Hierarchy (Ancestors)

Trauma and Stressor Related DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 24, 2021

First Posted

August 30, 2021

Study Start

August 30, 2021

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

January 12, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)