Accelerated Resolution Therapy for Early Maladaptive Grief

Mayo Clinic

Status: Enrolling

Conditions: Grief

Treatments: Other: Information and Support; Behavioral: Accelerated Resolution Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05624879

R01AG077656 (U.S. NIH Grant/Contract)

22-005315

Details and patient eligibility

About

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.

Full 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.

Enrollment: 440 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

440 participants in 2 patient groups

Accelerated Resolution Therapy Group

Experimental group

Description:

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)

Treatment:

Behavioral: Accelerated Resolution Therapy

Information and Support Group

Active Comparator group

Description:

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.

Treatment:

Other: Information and Support