Clinical trial NCT05624879: Accelerated Resolution Therapy for Early Maladaptive Grief
Official title: Accelerated Resolution Therapy for Early Maladaptive Grief: A Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Grief
Keywords: Family Caregiver
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-11-22
Enrollment: 440
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

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).

Primary outcomes:
measure: Changes in pre-loss grief
timeFrame: Baseline, 4 weeks
measure: Changes in prolonged grief disorder
timeFrame: 6 and 13 months post-bereavement
measure: Changes in clinical measure of prolonged grief disorder
timeFrame: 6 and 13 months post-bereavement
Secondary outcomes:
Other outcomes:
measure: Change in depression
timeFrame: Baseline, 4 weeks, 6 and 13 months post-bereavement
measure: Caregiver burden
timeFrame: Baseline
measure: Change in perceived stress
timeFrame: Baseline, 6 and 13 months post-bereavement
measure: Change in physical and mental health
timeFrame: Baseline, 6 and 13 months post-bereavement
measure: Pessimism
timeFrame: Baseline
measure: Change in life stressors
timeFrame: Baseline, 6 and 13 months post-bereavement
measure: Change in trauma symptoms
timeFrame: Baseline, 4 weeks, 6 and 13 months post-bereavement
measure: Change in social support
timeFrame: Baseline, 4 weeks, 6 and 13 months post-bereavement
measure: Change in anxiety
timeFrame: Baseline, 4 weeks, 6 and 13 months post-bereavement
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Clearwater
country: United States
facility: Suncoast Hospice
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Cindy Tofthagen, PhD
role: PRINCIPAL_INVESTIGATOR
References: