Prolonged Grief DisorderNCT07738133
Mechanisms Underlying Late-Life Prolonged Grief Disorder
A study testing Iyengar Yoga in people with Prolonged Grief Disorder, run by Medical College of Wisconsin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 89 years
- Conditions the study is for
- Prolonged Grief Disorder
- What is being tested?
- Iyengar Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to Jun 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Current alcohol/drug abuse or dependence
- Magnetic resonance imaging (MRI) contraindications
- Acute suicidality
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Keri Hainsworth, PhD, 414-852-9046, khainswo@mcw.edu
About this study
Official title: Probing Brain Network 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.
Read the 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.
- Conditions
- Prolonged Grief Disorder
- Being tested
- Iyengar Yoga, Health Education Control, Waitlist Control to Crossover
- Keywords
- Grief, Yoga, Health Education
- Medical subject headings
- Prolonged Grief Disorder, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iyengar YogaBehavioural
Participants will engage in 10 weekly IY classes
Health Education ControlBehavioural
Participants will engage in 10 weekly socialization control group sessions
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
| Study group | Role | What they receive |
|---|---|---|
| Yoga | Experimental | Participants will engage in 10 weekly IY classes Receives: Behavioral: Iyengar Yoga |
| Socialization Control | Active comparator | Participants will engage in 10 weekly socialization control group sessions Receives: Behavioral: Health Education Control |
| Waitlist Control | Other | Waitlist Control Receives: Other: Waitlist Control to Crossover |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline through study completion, up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study startJan 2027 (estimated)
- Primary completionJan 2031 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prolonged Grief DisorderStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Goveas, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07738133
- Sponsor's protocol ID
- PRO59299
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD cannot be shared due to confidentiality concerns for our patient population.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probing Brain Network Mechanisms Underlying Late-Life Prolonged Grief Disorder
- ClinicalTrials.gov ID
- NCT07738133
- Acronym / sponsor ID
- PRO59299
- Conditions
- Prolonged Grief Disorder
- Keywords
- Grief, Yoga, Health Education
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jan 2031 (estimated)
- Study completion
- Jun 2031 (estimated)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Yoga | Experimental | Behavioral: Iyengar YogaParticipants will engage in 10 weekly IY classes |
| Socialization Control | Active comparator | Behavioral: Health Education ControlParticipants will engage in 10 weekly socialization control group sessions |
| Waitlist Control | Other | Other: Waitlist Control to CrossoverWaitlist Control |
Who may qualify
- Ages
- 40 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iyengar YogaParticipants will engage in 10 weekly IY classes | Behavioural | Yoga |
| Health Education ControlParticipants will engage in 10 weekly socialization control group sessions | Behavioural | Socialization Control |
| Waitlist Control to CrossoverUpon Step 1 study completion (week 10), participants in this group who continue to meet PGD criteria on the SCIP will enter Step 2 phase | Other | Waitlist Control |
Primary outcome
Score on the Prolonged Grief 13-Revised (PG-13-R) scale
Time frame: Baseline through study completion, up to 10 weeks
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No. IPD cannot be shared due to confidentiality concerns for our patient population.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iyengar Yoga in people with Prolonged Grief Disorder, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joseph Goveas, MD (414-955-8970, jgoveas@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score on the Prolonged Grief 13-Revised (PG-13-R) scale (time frame: Baseline through study completion, up to 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.