Accelerated Resolution Therapy for Early Maladaptive Grief
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Accelerated Resolution Therapy, Information and Support.
- Who it may be relevant to
- Registry conditions: Grief. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Accelerated Resolution Therapy for Early Maladaptive Grief: A Clinical Trial
Overview
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.
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.
Interventions
- 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 Information and Support
4 sessions of a standardized social work intervention. Standard of care including education and active listening.
Primary outcome measures
- Changes in pre-loss grief [Time frame: Baseline, 4 weeks]
- Changes in prolonged grief disorder [Time frame: 6 and 13 months post-bereavement]
- Changes in clinical measure of prolonged grief disorder [Time frame: 6 and 13 months post-bereavement]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
United States · 4 centers
- Mayo Clinic Arizona — Phoenix
- Suncoast Hospice — Clearwater
- Mayo Clinic Florida — Jacksonville
- Mayo Clinic — Rochester
Identifiers
NCT: NCT05624879 · 22-005315 · R01AG077656