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

Trial Summary

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 data supports the effectiveness of the treatment RIVER for Grief?

Research on Accelerated Resolution Therapy (ART), a similar mind-body therapy, shows it significantly improves quality of life in older adults with complicated grief. This suggests that RIVER, which may share components with ART, could also be effective in treating grief. ^{1 2 3 4 5}

What is the purpose of this trial?

The United States is facing unprecedented rates of drug overdose deaths, profoundly impacting millions of families who are left to navigate their grief. Those bereaved by overdose experience a unique form of grief characterized by feelings of guilt, shame, and blame, which can worsen their suffering and deter them from seeking help. Individuals coping with overdose loss often endure more severe health consequences compared to those grieving non-drug related deaths, including prolonged grief disorder, substance use disorders, PTSD, depression, and suicidal thoughts. Moreover, bereaved individuals, particularly those with a history of substance use, may engage in risky behaviors as a means of coping, further exacerbating the risk of overdose and mortality within this vulnerable population. Peer grief support interventions have emerged as a promising approach to assist those experiencing such losses. To combat these outcomes, we are collaborating with Peer Community Support Partners (PSCP) in a novel practice-research partnership to implement the RIVER peer grief support model. Though RIVER has shown success in community settings, it has yet to be rigorously evaluated. 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 medical examiner offices (MEOs), which routinely contact families during death investigations. This research represents a pivotal advancement in addressing the needs of the overlooked bereaved community, aligning with the NIH's Helping to End Addiction Long-term (HEAL) initiative to develop effective strategies against the opioid crisis. Together, community engagement and rigorous research efforts aim to enhance support for those affected by the tragedy of drug overdose.

Research Team

Alison Athey, PhD

Principal Investigator

RAND

Karen Osilla, PhD

Principal Investigator

Stanford University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A Longitudinal Examination of Quality of Life of Older Adults with Complicated Grief Receiving Accelerated Resolution Therapy. [2023]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

Effect of a Brief Family-Based Treatment on Complicated Grief in Bereaved Older Adults. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Accelerated Resolution Therapy: Randomized Controlled Trial of a Complicated Grief Intervention. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Post-traumatic growth and optimism as outcomes of an internet-based intervention for complicated grief. [2007]

5. Canada pubmed.ncbi.nlm.nih.gov

Loss, grief, mourning: what to do. [2021]