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Mechanisms Underlying Late-Life Prolonged Grief Disorder

Probing Brain Network Mechanisms Underlying Late-Life Prolonged Grief Disorder

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07738133
Enrollment
126
Registered
2026-07-31
Start date
2027-01-01
Completion date
2031-06-01
Last updated
2026-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prolonged Grief Disorder

Keywords

Grief, Yoga, Health Education

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.

Detailed description

The objectives of this study are to (1) identify functional brain network features that differentiate PGD from integrated grief, and (2) conduct a mechanistic study in older adults with PGD to test whether exposure to 10-weeks of IY and HE modulate brain network targets and clarify how network changes relate to clinical response.

Interventions

BEHAVIORALIyengar Yoga

Participants will engage in 10 weekly IY classes

Participants will engage in 10 weekly socialization control group sessions

OTHERWaitlist Control to Crossover

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

Sponsors

Medical College of Wisconsin
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 89 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Score on the Prolonged Grief 13-Revised (PG-13-R) scaleBaseline through study completion, up to 10 weeksThe investigators 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).

Countries

United States

Contacts

CONTACTJoseph Goveas, MD
jgoveas@mcw.edu414-955-8970
CONTACTKeri Hainsworth, PhD
khainsworth@mcw.edu414-852-9046

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Oct 11, 2026