NCT07738133

Brief Summary

After losing a loved one, most successfully navigate acute grief and adapt to the loss within about 1 year, but in about 10%, prolonged grief disorder (PGD) ensues. This study is anticipated to provide novel evidence regarding the neurobiological mechanisms of PGD in older adults. The biological alterations identified here could provide targets to elucidate how currently available therapies work and inform novel mechanism-based interventions for treating late-life PGD.

Trial Health

63
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Trial Health Score

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

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
54mo left

Started Jan 2027

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 31, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2027

Expected
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2031

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2031

Last Updated

July 31, 2026

Status Verified

July 1, 2026

Enrollment Period

4 years

First QC Date

July 23, 2026

Last Update Submit

July 28, 2026

Conditions

Prolonged Grief Disorder

Keywords

GriefYogaHealth Education

Outcome Measures

Primary Outcomes (1)

  • Score on the Prolonged Grief 13-Revised (PG-13-R) scale

    We will measure change in the PG-13-R score from baseline to end of study. The PG-13-R scores range from 10 - 50 (higher scores indicate more severe grief symptoms).

    Baseline through study completion, up to 10 weeks

Study Arms (3)

Yoga

EXPERIMENTAL

Participants will engage in 10 weekly IY classes

Behavioral: Iyengar Yoga

Socialization Control

ACTIVE COMPARATOR

Participants will engage in 10 weekly socialization control group sessions

Behavioral: Health Education Control

Waitlist Control

OTHER

Waitlist Control

Other: Waitlist Control to Crossover

Interventions

Iyengar YogaBEHAVIORAL

Participants will engage in 10 weekly IY classes

Yoga
Health Education ControlBEHAVIORAL

Participants will engage in 10 weekly socialization control group sessions

Socialization Control
Waitlist Control to CrossoverOTHER

Upon Step 1 study completion (week 10), participants in this group who continue to meet PGD criteria on the SCIP will enter Step 2 phase

Waitlist Control

Eligibility Criteria

Age40 Years - 89 Years
Sexall
Healthy VolunteersNo
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

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Prolonged Grief DisorderHealth Education

Condition Hierarchy (Ancestors)

Trauma and Stressor Related DisordersMental DisordersAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Central Study Contacts

Joseph Goveas, MD

CONTACT

414-955-8970jgoveas@mcw.edu

Keri Hainsworth, PhD

CONTACT

414-852-9046khainsworth@mcw.edu

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, Department of Psychiatry and Behavioral Medicine

Study Record Dates

First Submitted

July 23, 2026

First Posted

July 31, 2026

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

January 1, 2031

Study Completion (Estimated)

June 1, 2031

Last Updated

July 31, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

IPD cannot be shared due to confidentiality concerns for our patient population.

Locations

US(1)