An interventional study of Accelerated Resolution Therapy and Information and Support in Grief, sponsored by Mayo Clinic. Recruiting at 4 sites in United States. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-25.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Supportive care
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.
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.
Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 669 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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
4 sessions of a standardized social work intervention. Standard of care including education and active listening.
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.
Time frame: 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.
Time frame: 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.
Time frame: 6 and 13 months post-bereavement
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.
Time frame: Baseline, 4 weeks, 6 and 13 months post-bereavement
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.
Time frame: Baseline
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.
Time frame: 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.
Time frame: Baseline, 6 and 13 months post-bereavement
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
Time frame: Baseline
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Baseline, 4 weeks, 6 and 13 months post-bereavement
Plan to share: No
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