Mechanisms Underlying Late-Life Prolonged Grief Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Iyengar Yoga, Health Education Control, Waitlist Control to Crossover.
- Who it may be relevant to
- Registry conditions: Prolonged Grief Disorder. Basic parameters: 40 years — 89 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Probing Brain Network Mechanisms Underlying Late-Life Prolonged Grief Disorder
Overview
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
- Behavioral Iyengar Yoga
Participants will engage in 10 weekly IY classes - Behavioral Health Education Control
Participants will engage in 10 weekly socialization control group sessions - Other Waitlist 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
Primary outcome measures
- Score on the Prolonged Grief 13-Revised (PG-13-R) scale [Time frame: Baseline through study completion, up to 10 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Medical College of Wisconsin — Milwaukee
Identifiers
NCT: NCT07738133 · PRO59299