RIVER for Grief

Recruiting at 3 trial locations

Overseen By Karen Osilla, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: RAND

Disqualifiers: Hospitalization, Suicidal ideation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 months

340 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a peer grief support model called RIVER to assist those who have lost a loved one to a drug overdose. The researchers aim to determine if this support can reduce feelings of guilt, shame, and blame, and help prevent severe health issues like depression and PTSD. Participants will join one of two groups: one will receive peer support and additional resources, while the other will receive standard resources for grief support (enhanced care as usual). Individuals who lost a loved one to an accidental overdose within the past year and do not currently require hospitalization for mental health or substance issues might be a good fit. This unphased trial offers a unique opportunity to contribute to innovative grief support research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on peer grief support, so it's unlikely that medication changes are required, but you should confirm with the trial organizers.

What prior data suggests that the RIVER peer grief support model is safe?

Research has shown that the RIVER peer grief support model effectively aids communities in coping with drug overdose deaths. While clinical trials have not provided specific safety data, the model relies on non-medical peer support, which is generally considered safe. This approach avoids medications or medical procedures, reducing the risk of physical side effects.

The RIVER model draws on years of experience from Peer Support Community Partners, who have developed a standardized method for assisting individuals through grief. This experience indicates that the model is well-received. As a "Not Applicable" phase trial, it evaluates the approach rather than testing a new drug, typically resulting in a lower risk of negative effects. Overall, the RIVER model appears to be a safe support option for those grieving overdose loss. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the RIVER approach for grief because it offers a unique blend of peer support with enhanced traditional care. Unlike standard grief treatments that may primarily involve therapy or support groups, RIVER pairs participants with a peer grief support specialist, providing personalized support based on a new process model. This method aims to deepen emotional connection and understanding, potentially offering more tailored and empathetic support than traditional methods. By combining this with psychoeducational resources, RIVER could lead to more comprehensive and effective grief management.

What evidence suggests that the RIVER peer grief support model is effective for those grieving overdose loss?

Research has shown that the RIVER peer grief support model, which participants in this trial may receive, can effectively support individuals who have lost loved ones to drug overdoses. This method addresses the unique feelings of guilt, shame, and blame that often arise in these situations. Early findings suggest that those using the RIVER model may experience improved health outcomes, such as fewer symptoms of prolonged grief disorder and depression. The model includes trained peers who provide essential support and guidance for those dealing with grief. While it has succeeded in community settings, further evaluation is ongoing to confirm its effectiveness. ^{1 6 7 8 9}

Who Is on the Research Team?

Karen Osilla, PhD

Principal Investigator

Stanford University

Alison Athey, PhD

Principal Investigator

RAND

Are You a Good Fit for This Trial?

This trial is for individuals grieving from the loss of a loved one due to drug overdose. It's aimed at those who may be experiencing intense feelings of guilt, shame, and prolonged grief, which could lead to substance use disorders or other mental health issues.

Inclusion Criteria

People who lost a loved one to an unintentional drug overdose death within the past year

I am mentally capable of understanding and consenting to participate.

Exclusion Criteria

People who need hospitalization for psychiatric symptoms or substance use disorders (Note, people who use drugs but who do not require hospitalization will be included)

People have active suicidal ideation

People who lost someone to a drug overdose death more than one year ago

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive peer grief support through the RIVER model and enhanced care as usual

12 months

Regular sessions with peer support specialists

Follow-up

Participants are monitored for changes in grief symptoms, coping strategies, and mental health outcomes

12 months

Follow-up assessments at 3, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced care as usual
• RIVER

Trial Overview The study tests the RIVER peer grief support model against enhanced care as usual. The goal is to see if RIVER can better help people cope with their grief after an overdose death by providing support through medical examiner offices.

How Is the Trial Designed?

Group I: Peer grief support + enhanced care as usual Experimental Treatment 2 Interventions

Participants in this arm will be matched with a peer grief support specialist who will provide support that aligns with the RIVER process model developed by Peer Community Support Partners. They will also receive a psychoeducational booklet and a list of local grief support resources (i.e., the enhanced care as usual condition).

Group II: Enhanced care as usual Active Control 1 Intervention

Participants will receive a psychoeducational booklet and a list of local grief support resources.

Who Is Running the Clinical Trial?

RAND

Lead Sponsor

Trials

145

Recruited

617,000+

Peer Support Community Partners

Collaborator

Trials

1

Recruited

340+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

Accelerated resolution therapy (ART) significantly reduced complicated grief (CG) symptoms in older adults, with participants showing an average reduction of -22.8 compared to only -4.3 in the wait-list group, indicating ART's effectiveness as a treatment.

The study involved 54 participants aged 60 and older, and ART also demonstrated substantial improvements in PTSD and depression symptoms, suggesting it could be a promising, less time-intensive intervention for these conditions as well.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated Resolution Therapy: Randomized Controlled Trial of a Complicated Grief Intervention. Buck, HG., Cairns, P., Emechebe, N., et al.[2022]

Accelerated Resolution Therapy (ART) significantly improved the quality of life (QOL) for older adults experiencing complicated grief, with a notable improvement of 8.21 points in QOL scores over time based on a study of 27 participants.

Both the therapy itself and the duration of treatment contributed to the improvement in QOL, indicating that ART is an effective intervention for enhancing the well-being of older adults dealing with grief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Longitudinal Examination of Quality of Life of Older Adults with Complicated Grief Receiving Accelerated Resolution Therapy. Mason, TM., Szalacha, LA., Tofthagen, CS., et al.[2023]

Citations

1. researchgate.net researchgate.net/publication/394839504_Study_protocol_for_a_randomized_trial_examining_a_peer_grief_support_approach_for_people_grieving_drug_overdose_deaths

Study protocol for a randomized trial examining a peer grief ... The rst half of training focuses on using the RIVER peer grief support approach. Peers are trained in this process model through a combination ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12393464/

Study protocol for a randomized trial examining a peer grief ... This study tests the RIVER peer grief support model for drug overdose deaths, comparing it to usual care in a randomized trial to improve health outcomes.

3. peersupportcommunitypartners.com peersupportcommunitypartners.com/river

RIVER Peer Grief Support Model The RIVER model — developed by PSCP to set the standard for delivering Peer Grief Support (PGS) to grieving people — is based on the PSCP owners' combined six ...

4. withpower.com withpower.com/trial/phase-grief-disorder-prolonged-8-2026-e6b49

RIVER for Grief In a three-aim approach, this study aims to assess the effectiveness of the RIVER model while also enhancing and engaging grievers with support resources via ...

5. reporter.nih.gov reporter.nih.gov/search/Rv6_Ea2Z0kuAzhV2hrAEfA/project-details/11059008

Project Details Peer grief support interventions hold promise for those who are grieving and may be especially important for this population because of the increased stigma ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40894007/

Study protocol for a randomized trial examining a peer grief ... In the second phase, we will compare enhanced usual care (EUC) to EUC plus RIVER peer grief support (RIVER) in a randomized controlled trial.

7. discovery.researcher.life discovery.researcher.life/article/study-protocol-for-a-randomized-trial-examining-a-peer-grief-support-approach-for-people-grieving-drug-overdose-deaths/ba52e92db0713fd6bade08f6abcfdf94

Study protocol for a randomized trial examining a peer grief support ... Peer Support Community Partners has developed the RIVER peer grief support model for bereavement. The model has been implemented successfully in the ...

8. researchgate.net researchgate.net/publication/319496600_Peer_Support_Services_for_Bereaved_Survivors_A_Systematic_Review

(PDF) Peer Support Services for Bereaved Survivors This systematic literature review assesses the evidence regarding benefits of peer support services for bereaved survivors of sudden or ...

9. peersupportcommunitypartners.com peersupportcommunitypartners.com/river-in-depth

RIVER Peer Grief Support Model: Overview and Rationale The purpose of the RIVER Peer Grief Support Model 1 is to enable a person bereaved by the death of someone close to them 2 who has experienced significant ...