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NCT Number: NCT07738133

Mechanisms Underlying Late-Life Prolonged Grief Disorder

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.

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Key information

Conditions

Prolonged Grief Disorder Adherence Interventions Behavior Health Behavior Health Education Medication Adherence Mental Disorders Patient Acceptance of Health Care Patient Compliance Trauma and Stressor Related Disorders Treatment Adherence and Compliance

Age range

40 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location contact

Keri Hainsworth, PhD

CONTACT

[email protected]

414-852-9046

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Iyengar Yoga

Behavioral

Participants will engage in 10 weekly IY classes

Health Education Control

Behavioral

Participants will engage in 10 weekly socialization control group sessions

Waitlist Control to Crossover

Other

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

Primary outcomes

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

    Time frame: Baseline through study completion, up to 10 weeks

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Joseph Goveas, MD

CONTACT

[email protected]

414-955-8970

Keri Hainsworth, PhD

CONTACT

[email protected]

414-852-9046

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Official study title

Probing Brain Network Mechanisms Underlying Late-Life Prolonged Grief Disorder

Important dates

Study start
2027
Primary completion
2031
Study completion
2031
First posted
Jul 31, 2026
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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