Accelerated Resolution Therapy for Early Maladaptive Grief

Study Overview
=================
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.

Official Title
-----------------
Accelerated Resolution Therapy for Early Maladaptive Grief: A Clinical Trial

Conditions
-----------------
Grief

Intervention / Treatment
-----------------
* Behavioral: Accelerated Resolution Therapy
* Other: Information and Support


Participation Criteria
=================
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 Score of 33 or higher on the (DSM-5 PTSD checklist/PCL-5) indicating significant psychological trauma 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).

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Accelerated Resolution Therapy Group<br>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<br>* 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.<br>* Other names: ART;|
| Active Comparator: Information and Support Group<br>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<br>* 4 sessions of a standardized social work intervention. Standard of care including education and active listening.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 6 and 13 months post-bereavement | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Family Caregiver