Accelerated Resolution Therapy for Grief

Recruiting at 3 trial locations

Overseen By Katharine E Sheffield, MA, CCRP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Bipolar, Schizophrenia, Alcohol/drug dependence, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 4 weeks

440 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how accelerated resolution therapy (ART) can assist with grief before and after losing a loved one. It targets older adults who are primary caregivers of a family member in hospice or palliative care. Participants will either receive ART or join an information and support group to determine which method more effectively manages grief. Ideal candidates have a family member expected to live less than a year and are experiencing significant grief. As an unphased trial, this study provides participants the opportunity to contribute to valuable research that could enhance grief management for caregivers.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that accelerated resolution therapy is safe for older adult family caregivers?

Research shows that Accelerated Resolution Therapy (ART) is generally easy for patients to handle. Studies have found that ART can greatly reduce symptoms of PTSD (post-traumatic stress disorder) and depression. For instance, one study reported that 94% of participants completed the therapy, indicating that most people continue with the treatment without major problems.

Although ART is a newer therapy, these results offer some reassurance about its safety for people dealing with grief. The therapy uses methods like imagining distressing events to help process them and moving the eyes side-to-side, which have been safely used in similar therapies.

Overall, based on current research, ART seems to be a safe option for those looking for new ways to cope with grief. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Accelerated Resolution Therapy (ART) is unique because it offers a rapid approach to managing grief, unlike traditional therapies that often require longer durations to see results. Most treatments for grief, like cognitive behavioral therapy or talk therapy, focus on processing emotions over time. ART, however, uses a combination of image rescripting and eye movements to help individuals quickly reframe distressing memories. Researchers are excited about ART because it has the potential to deliver significant emotional relief in just a few sessions, providing a faster, innovative alternative to conventional therapy methods.

What evidence suggests that accelerated resolution therapy could be effective for grief?

Research has shown that Accelerated Resolution Therapy (ART), which participants in this trial may receive, helps reduce symptoms of prolonged grief disorder in older adults caring for family members. A previous study found that ART eased grief symptoms, making it a promising option for those with complicated grief. ART is a brief therapy that can lead to quick improvements, appealing to those seeking fast treatment. Other studies have also shown that ART significantly reduces symptoms in various mental health disorders, highlighting its broad potential. These findings suggest that ART could be a useful tool for those dealing with grief. ^{1 3 6 7 8}

Who Is on the Research Team?

Cindy Tofthagen, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for older adult caregivers experiencing intense grief, caring for an immediate family member with less than a year to live. Participants must show signs of psychological trauma but not be suicidal or have psychotic behavior. They can't have had similar psychotherapy since becoming a caregiver, nor suffer from major psychiatric disorders, substance dependence, or cognitive impairment.

Inclusion Criteria

Primary caregiver of immediate family member who has a life expectancy of less than 12 months

Denial of suicidal ideation or intent, with no evidence of psychotic behavior.

Score of 30 or higher on the PG-12-R, indicating clinically significant pre-loss grief

Exclusion Criteria

Cognitive impairment (SPMSQ > 4 errors)

As a caregiver, I have undergone trauma-focused therapy like EMDR or CBT.

Score of > 2 on the adapted CAGE questionnaire indicating alcohol/drug dependence

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive four weekly sessions of either Accelerated Resolution Therapy (ART) or an educational program

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for changes in grief, anxiety, stress, and other psychological factors post-treatment

13 months

3 visits (in-person) at 6 and 13 months post-bereavement

What Are the Treatments Tested in This Trial?

Interventions

• Accelerated Resolution Therapy

Trial Overview The study tests Accelerated Resolution Therapy (ART) on caregivers dealing with pre-loss and prolonged grief. It aims to understand who benefits most from ART and how it affects the thinking processes of those grieving.

How Is the Trial Designed?

Group I: Accelerated Resolution Therapy Group Experimental Treatment 1 Intervention

Primary caregivers of an immediate family member enrolled in a hospice or palliative care program will receive 4 weekly sessions of accelerated resolution therapy (ART)

Group II: Information and Support Group Active Control 1 Intervention

Primary caregivers of an immediate family member enrolled in a hospice or palliative care program will receive four-time and attention matched sessions of a standardized social work intervention consisting of information and provision of emotional support.

Accelerated Resolution Therapy is already approved in United States for the following indications:

Approved in United States as Accelerated Resolution Therapy for:

• PTSD
• Depression
• Stress
• Personal Resilience
• Phobia
• Panic
• Anxiety
• Sleep and Wake Disorders
• Disruptive and Antisocial Behaviors
• General Functioning and Well-being
• Early Maladaptive Grief
• Prolonged Grief Disorder

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

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) shows promise for treating Prolonged Grief Disorder (PGD), with insights from a qualitative study of 29 bereaved caregivers revealing how their expectations of ART are shaped by their knowledge and personality traits.

Participants who articulated a clear process for recovery had more specific expectations about ART, suggesting that understanding these intrapersonal factors could enhance the therapy's effectiveness and inform future research directions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the role of expectancy in older US participants' response to an accelerated resolution therapy intervention for prolonged grief disorder. Buck, HG., Benitez, B., Mason, T., et al.[2023]

In a study of 70 individuals diagnosed with HIV at a community clinic, 27% received antiretroviral therapy (ART) prescriptions within 7 days of diagnosis, demonstrating the feasibility of rapid ART initiation.

Patients who started ART rapidly achieved viral suppression in a median of 55 days, which is 22 days faster than the standard time, highlighting the effectiveness of this approach in reducing HIV transmission.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid Antiretroviral Therapy (ART) Initiation at a Community-Based Clinic in Jackson, MS. Gomillia, CES., Backus, KV., Brock, JB., et al.[2021]

In a study of adults with advanced HIV and pulmonary tuberculosis, early immunologic response to antiretroviral therapy (ART) was found to be a significant predictor of early mortality, rather than pre-ART CD4 counts or viral load changes.

An increase of 20 cells/µL in CD4 count after 4 weeks of ART was associated with a 40% reduction in the odds of death, highlighting the importance of monitoring immune recovery in patients starting ART.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early immunologic failure is associated with early mortality among advanced HIV-infected adults initiating antiretroviral therapy with active tuberculosis. Ravimohan, S., Tamuhla, N., Steenhoff, AP., et al.[2022]

Initiating antiretroviral therapy (ART) on the same day as diagnosis leads to earlier viral suppression in patients, which is a promising strategy for managing HIV.

A study involving 195 patients at CrescentCare in New Orleans provides important long-term data on the effectiveness of immediate ART, supporting its potential for broader implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Care Continuum of Immediate ART for Newly Diagnosed Patients and Patients Presenting Later to Care at a Federally Qualified Health Center in New Orleans. Halperin, J., Conner, K., Butler, I., et al.[2020]

In a study of 631 newly diagnosed HIV patients in Taiwan, rapid initiation of antiretroviral therapy (ART) within 7 days of diagnosis led to a significantly higher engagement in care at 12 months (88.3% vs 79.0% for standard initiation).

Rapid ART initiation also reduced the median time to achieve viral suppression from 138 days to 47 days, highlighting its effectiveness in improving patient outcomes and potentially reducing onward HIV transmission.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term outcomes of rapid initiation of antiretroviral therapy among HIV-positive patients: real-world experience from a single-centre retrospective cohort in Taiwan. Huang, YC., Sun, HY., Chuang, YC., et al.[2020]

Accelerated Resolution Therapy (ART) shows promise as a brief psychotherapy for treating complicated grief in older adults, particularly when PTSD symptoms are present, as demonstrated in two case studies.

Both individuals in the case studies had previously undergone traditional grief therapy without sufficient relief, highlighting ART's potential effectiveness in addressing residual grief symptoms and improving overall mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complicated Grief With Post-Traumatic Stress Disorder Addressed With Accelerated Resolution Therapy: Case Discussions. Tofthagen, C., Hernandez, DF., Mason, TM., et al.[2022]

Accelerated Resolution Therapy (ART) is a new imaginative psychotherapy that shows promise for quickly resolving various psychiatric symptoms, based on limited studies including one randomized controlled trial with 57 subjects.

Current research suggests ART is effective and versatile, but more high-quality randomized controlled trials are needed to fully explore its potential benefits and applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated Resolution Therapy (ART): a Review and Research to Date. Waits, W., Marumoto, M., Weaver, J.[2020]

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]

One-on-one counseling significantly improves adherence to antiretroviral therapy (ART) in HIV patients, with six out of nine studies showing positive outcomes over intervention periods of 4 to 18 months.

Face-to-face and computer-based counseling methods were effective, while telephone counseling did not yield the same results, indicating that the mode of delivery is crucial for successful adherence interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Counseling for improving adherence to antiretroviral treatment: a systematic review. Musayón-Oblitas, Y., Cárcamo, C., Gimbel, S.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11880351/

Accelerated Resolution Therapy for Early Maladaptive ... Our previous waitlist controlled trial demonstrated that ART alleviates prolonged grief disorder among older adult FCGs.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8168719/

Randomized Controlled Trial of a Complicated Grief ... Results suggests that ART presents an effective and less time-intensive intervention for CG in older adults. However, it should undergo further effectiveness ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05624879?tab=table

Accelerated Resolution Therapy for Early Maladaptive Grief The purpose study is to test the effects of accelerated resolution therapy (ART) on pre-loss grief and prolonged grief disorder among older adult family ...

4. journals.plos.org journals.plos.org/mentalhealth/article?id=10.1371/journal.pmen.0000123

Accelerated Resolution Therapy (ART) for the treatment of ... Included studies reported a significant reduction in symptoms of PTSD from pre- to post-intervention, d = 1.12 to 3.28. Significant reductions ...

5. acceleratedresolutiontherapy.com acceleratedresolutiontherapy.com/wp-content/uploads/2023/01/11.-ART-Review-Current-Psychiatry-Reports-2017.pdf

a Review and Research to Date Accelerated resolution therapy (ART) is a brief evidence- based psychotherapy that can produce dramatic improvements in a variety of psychiatric disorders ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05624879

Accelerated Resolution Therapy for Early Maladaptive Grief The purpose study is to test the effects of accelerated resolution therapy (ART) on pre-loss grief and prolonged grief disorder among older adult family ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6145606/

Ethical Reflections on Offering Patients Accelerated ... The ART was delivered in 3.7±1.1 sessions with a 94-percent completion rate. The investigators reported that mean reductions in symptoms of PTSD, depression, ...

8. acceleratedresolutiontherapy.com acceleratedresolutiontherapy.com/wp-content/uploads/2023/01/18.-ART-for-Prolonged-Grief-2020.pdf

Randomized Controlled Trial of a Complicated Grief ... We report on a randomized clinical trial (RCT) which examined whether accelerated resolution therapy (ART), a novel mind-body therapy, is effective in treating ...