Accelerated Resolution Therapy for Early Maladaptive Grief

NCT05624879 | Recruiting DMC

• 2 other identifiers: 22-005315R01AG077656
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 4

Brief Summary

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 caregivers (FCGs). Additionally, to better understand predictors of response to ART, and cognitive processes that occur among grieving individuals following ART.

Conditions

Grief

Keywords

Family Caregiver

Outcome Measures

Primary Outcomes (3)

• Changes in pre-loss grief

  Measured by 14-item self-reported Prolonged Grief-12-Revised (PG-12-R) designed to measure the grief experience of current family caregivers of persons living with progressive disease. Total grief level scores greater than or equal to 30 indicate high levels of pre-loss grief.

  Baseline, 4 weeks

• Changes in prolonged grief disorder

  Measured by 13-item self-reported Prolonged Grief-13-Revised (PG-13-R) designed to assess indicators of pathological grief. Total scores range from 10-50; with score \>29 = prolonged grief.

  6 and 13 months post-bereavement

• Changes in clinical measure of prolonged grief disorder

  Measured by 31-item Structured Clinical Interview for Prolonged Grief Disorder (SCI-P) administered by healthcare professional. Higher scores = higher complicated grief symptoms.

  6 and 13 months post-bereavement

Other Outcomes (9)

• Change in depression

  Baseline, 4 weeks, 6 and 13 months post-bereavement

• Caregiver burden

  Baseline

• Change in perceived stress

  Baseline, 6 and 13 months post-bereavement

Study Arms (2)

Accelerated Resolution Therapy Group

EXPERIMENTAL

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)

Behavioral: Accelerated Resolution Therapy

Information and Support Group

ACTIVE COMPARATOR

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.

Other: Information and Support

Interventions

Accelerated Resolution Therapy BEHAVIORAL

A brief psychotherapeutic intervention delivered by trained therapists in a maximum of 4 sessions. Sessions will focus on providing relief from the distress related to an anticipated loss and to shift focus from distress and loss back to the relationship.

Also known as: ART

Accelerated Resolution Therapy Group

Information and Support OTHER

4 sessions of a standardized social work intervention. Standard of care including education and active listening.

Information and Support Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary caregiver of immediate family member who has 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.

You may not qualify if:

• Since becoming a family caregiver (FCG), they have engaged in another trauma based psychotherapeutic regimen (EMDR, prolonged exposure therapy, trauma focused cognitive behavioral therapy) that could influence response to accelerated resolution therapy (ART).
• Self-reported or clinically assessed major psychiatric disorder (e.g., bipolar disorder, schizophrenia).
• Score of \> 2 on the adapted CAGE questionnaire indicating alcohol /drug dependence.
• Cognitive impairment (SPMSQ \> 4 errors).

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute on Aging (NIA): collaborator

Study Sites (4)

Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States

RECRUITING

Suncoast Hospice

Clearwater, Florida, 33760, United States

RECRUITING

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Interventions

Palliative Care

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Cindy Tofthagen, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katharine E Sheffield, MA, CCRP

CONTACT

904-953-3972; Sheffield.Katharine@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: November 22, 2022
• Study Start: November 17, 2023
• Primary Completion (Estimated): March 14, 2028
• Study Completion (Estimated): March 14, 2028
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)