GriefNCT05624879
Accelerated Resolution Therapy for Early Maladaptive Grief
A study testing Accelerated Resolution Therapy and Information and Support in people with Grief, run by Mayo Clinic at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Grief
- What is being tested?
- Accelerated Resolution Therapy and Information and Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 4 sitesUnited States
- Study dates
- 17 Nov 2023to 14 Mar 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Suncoast Hospice
Clearwater, Florida, 33760
Ronald Featherstone, LCSW
- Recruiting
Mayo Clinic Florida
Jacksonville, Florida, 32224
- Recruiting
Mayo Clinic Arizona
Phoenix, Arizona, 85054
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: 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.
Read the 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.
- Conditions
- Grief
- Being tested
- Accelerated Resolution Therapy, Information and Support
- Keywords
- Family Caregiver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerated Resolution TherapyBehavioural
Also called ART
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.
Information and SupportOther
4 sessions of a standardized social work intervention. Standard of care including education and active listening.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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. Receives: Other: Information and Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months post-randomization, 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.
Measured: 6 and 13 months post-bereavement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2022
- Study start17 Nov 2023
- Primary completion14 Mar 2028 (estimated)
- Study completion14 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GriefStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Cindy Tofthagen, Mayo Clinic
- Investigators
- Cindy Tofthagen, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05624879
- Sponsor's protocol ID
- 22-005315
- Other IDs
- R01AG077656
- Status last verified
- Sep 2026
- First submitted
- 15 Nov 2022
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No