Actively Recruiting

Phase Not Applicable
Age: 60Years +
All Genders
Healthy Volunteers
ID05624879

Accelerated Resolution Therapy for Early Maladaptive Grief: A Clinical Trial

Led by Mayo Clinic ยท Updated on 2025-09-25

440

Participants Needed

4

Research Sites

N/A

Total Duration

On this page

Sponsors

M

Mayo Clinic

Lead Sponsor

N

National Institute on Aging (NIA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of Accelerated Resolution Therapy (ART) on pre-loss grief and prolonged grief disorder in older adult family caregivers. The study aims to understand how ART may help alleviate maladaptive grief before bereavement and prevent prolonged grief disorder afterwards. It also seeks to explore cognitive changes and factors that predict response to ART among grieving individuals. This clinical trial randomly assigns primary caregivers of immediate family members enrolled in hospice or palliative care to receive either four weekly sessions of ART or four sessions of an educational and emotional support program matched for time and attention. ART is a brief psychotherapeutic approach designed to reduce distress related to anticipated loss and refocus attention on the relationship rather than the loss. Participants will be assessed at enrollment, after the four-session intervention, and then at six and thirteen months post-bereavement. A subgroup will participate in interviews to explore cognitive changes. The researchers will measure changes in pre-loss grief and prolonged grief disorder using clinical scales to evaluate the potential benefits of ART as a first-line or preventive treatment. The total participation duration spans over a year with multiple evaluation points.

CONDITIONS

Brief Title

Accelerated Resolution Therapy for Early Maladaptive Grief

Who Can Participate

Age: 60Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Primary caregiver of an immediate family member with a life expectancy of less than 12 months
  • Score of 30 or higher on the PG-12-R indicating clinically significant pre-loss grief
  • Denial of suicidal ideation or intent, with no evidence of psychotic behavior
  • Age 60 years or older
Not Eligible

You will not qualify if you...

  • Participation in trauma-based psychotherapeutic treatments (e.g., EMDR, prolonged exposure therapy, trauma-focused cognitive behavioral therapy) since becoming a caregiver
  • Presence of major psychiatric disorders such as bipolar disorder or schizophrenia
  • Score greater than 2 on the adapted CAGE questionnaire indicating alcohol or drug dependence
  • Cognitive impairment with more than 4 errors on the SPMSQ test

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

screening and enrollment visit

Outpatient Treatment

Duration - 4 weeks

Participants receive four weekly sessions of either Accelerated Resolution Therapy (ART) or a standardized social work intervention focused on information and emotional support to address pre-loss grief.

4 weekly visits (in-person or remote depending on protocol)

Follow-up

Duration - Up to 13 months post-bereavement

Participants are assessed at 6 and 13 months post-bereavement to evaluate changes in prolonged grief disorder and related clinical measures.

2 follow-up visits

Trial Site Locations

Total: 4 locations

1

Mayo Clinic Arizona

Phoenix, Arizona, United States, 85054

Actively Recruiting

2

Suncoast Hospice

Clearwater, Florida, United States, 33760

Actively Recruiting

3

Mayo Clinic Florida

Jacksonville, Florida, United States, 32224

Actively Recruiting

4

Mayo Clinic

Rochester, Minnesota, United States, 55905

Actively Recruiting

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Research Team

K

Katharine E Sheffield, MA, CCRP

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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