Mechanisms Underlying Late-Life Prolonged Grief Disorder

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-89
SponsorMedical College of Wisconsin

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    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

Treatment groups

126 Participants
are divided into 3 treatment groups
Group A: YogaExperimental treatment 1 intervention
Group B: Socialization ControlActive comparator 1 intervention
Group C: Waitlist ControlOther 1 intervention

Trial outcomes

Primary outcomes

1

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

The 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).

Time frame
Baseline through study completion, up to 10 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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