Accelerated Resolution Therapy for Early Maladaptive Grief

Accelerated Resolution Therapy for Early Maladaptive Grief: A Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Grief
• Intervention / Treatment: Behavioral: Accelerated Resolution Therapy; Other: Information and Support

Detailed Description

Accelerated Resolution Therapy (ART) is an evidence-based treatment for post-traumatic distress in civilians and veterans that may be useful in alleviating maladaptive grief prior to bereavement and could prevent prolonged grief disorder following bereavement. Researchers are proposing to test the efficacy of ART, a low-risk, brief therapy with a strong theoretical rationale for treatment success in maladaptive grief and supported by the promising results of a recently completed preliminary trial. Additional aims of the study are to examine changes in cognitive appraisal and integration of loss following ART using a mixed methods approach and to evaluate personal, social, and psychological factors predictors of response.

During the proposed double blinded, randomized, controlled two arm clinical trial, older adult family caregivers will receive either ART or an educational program that is matched for time and attention. Each participant will receive four sessions of either the ART intervention or the control intervention. Data collection will occur at screening/enrollment (T1), at the end of the 4-session intervention period (T2) and at 6-months (T3) and 13-months post bereavement (T4). A subgroup of 20 participants randomly assigned to ART will participate in semi-structured interviews to enhance understanding of cognitive appraisal and integration of loss.

This trial will provide critical information on the efficacy of the ART intervention as a potential first-line treatment option for pre-loss grief and preventative option for prolonged grief disorder, and contribute new information about characteristics of individuals most likely to benefit from ART.

• Study Type: Interventional
• Enrollment (Estimated): 440
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katharine E Sheffield, MA, CCRP; Phone Number: 904-953-3972; Email: Sheffield.Katharine@mayo.edu

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Recruiting
      • Mayo Clinic Arizona
  • Florida
    • Clearwater, Florida, United States, 33760
      • Recruiting
      • Suncoast Hospice
      • Contact: Ronald Featherstone, LCSW
    • Jacksonville, Florida, United States, 32224
      • Recruiting
      • Mayo Clinic Florida
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Accelerated Resolution Therapy Group; 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; 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.; Other Names: ART
Active Comparator: Information and Support Group; 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; 4 sessions of a standardized social work intervention. Standard of care including education and active listening.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caregiver burden	Measured using the self-reported 4-item Caregiver Role Overload questionnaire. Individual statement agreement on scale of "completely" agree to "not at all". Higher responses indicate more burden.	Baseline
Pessimism	Measured using the self-reported 10-item Revised Life Orientation Test (LOT-R). Total score range from 0-40, with higher scores indicating more optimistic	Baseline
Change in depression	Measured using the self-reported 9-item Personal Health Questionnaire (PHQ-9) to assess how often subjects have been bother about specific problems in the last 2 weeks. Total scores range from 0-27; with score >9 = depression.	Baseline, 4 weeks, 6 and 13 months post-bereavement
Change in perceived stress	Measured using the self-reported 10-item NIH toolbox Item Bank/Fixed Form v2.0 - Perceived Stress questionnaire. Score range from 26-34; with higher score indicating worse stress.	Baseline, 6 and 13 months post-bereavement
Change in physical and mental health	Measured using the self-reported 10-item Patient-Reported Outcomes Measurement Information System (PROMIS)-Global Health questionnaire. Total score range 0-20; with higher scores indicate better health.	Baseline, 6 and 13 months post-bereavement
Change in life stressors	Measured using the self-reported 13-item Social Readjustment Rating Scale where subjects indicate Yes or No and frequency of events that have occurred or expected to occur.	Baseline, 6 and 13 months post-bereavement
Change in trauma symptoms	Measured using the self-reported 20 item PTSD Checklist for DSM-5 (PCL-5) assess subjects response to very stressful experiences within the past week. Score range from 0-80; with cut-point for PTSD of 33.	Baseline, 4 weeks, 6 and 13 months post-bereavement
Change in social support	Measured using the self-reported 8-item NIH toolbox Item Bank v2.0 - Emotional Support questionnaire. Score range from 8-40; with higher score indicating better emotional support.	Baseline, 4 weeks, 6 and 13 months post-bereavement
Change in anxiety	Measured using the self-reported 7-item Generalized Anxiety Disorder Scale (GAD-7) to assess anxiety symptoms is the last week. Total score range from 0-2; with score >9 = high anxiety	Baseline, 4 weeks, 6 and 13 months post-bereavement

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Cindy Tofthagen, PhD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2023
• Primary Completion (Estimated): March 14, 2028
• Study Completion (Estimated): March 14, 2028

Study Registration Dates

• First Submitted: November 15, 2022
• First Submitted That Met QC Criteria: November 15, 2022
• First Posted (Actual): November 22, 2022

Study Record Updates

• Last Update Posted (Estimated): September 25, 2025
• Last Update Submitted That Met QC Criteria: September 22, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Family Caregiver
• Additional Relevant MeSH Terms: Therapeutics; Patient Care; Health Services; Health Care Facilities Workforce and Services; Palliative Care
• Other Study ID Numbers: 22-005315; R01AG077656 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No