Grief Clinical Trial
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.
Status | Recruiting |
Enrollment | 440 |
Est. completion date | March 14, 2028 |
Est. primary completion date | March 14, 2028 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years and older |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic Florida | Jacksonville | Florida |
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in depression | Measured using the self-reported 9-item Personal Health Questionnaire (PHQ-9) to assess how often subjects have been bother about specific problems in the last 2 weeks. Total scores range from 0-27; with score >9 = depression. | Baseline, 4 weeks, 6 and 13 months post-bereavement | |
Other | Caregiver burden | Measured using the self-reported 4-item Caregiver Role Overload questionnaire. Individual statement agreement on scale of "completely" agree to "not at all". Higher responses indicate more burden. | Baseline | |
Other | Change in perceived stress | Measured using the self-reported 10-item NIH toolbox Item Bank/Fixed Form v2.0 - Perceived Stress questionnaire. Score range from 26-34; with higher score indicating worse stress. | Baseline, 6 and 13 months post-bereavement | |
Other | Change in physical and mental health | Measured using the self-reported 10-item Patient-Reported Outcomes Measurement Information System (PROMIS)-Global Health questionnaire. Total score range 0-20; with higher scores indicate better health. | Baseline, 6 and 13 months post-bereavement | |
Other | Pessimism | Measured using the self-reported 10-item Revised Life Orientation Test (LOT-R). Total score range from 0-40, with higher scores indicating more optimistic | Baseline | |
Other | Change in life stressors | Measured using the self-reported 13-item Social Readjustment Rating Scale where subjects indicate Yes or No and frequency of events that have occurred or expected to occur. | Baseline, 6 and 13 months post-bereavement | |
Other | Change in trauma symptoms | Measured using the self-reported 20 item PTSD Checklist for DSM-5 (PCL-5) assess subjects response to very stressful experiences within the past week. Score range from 0-80; with cut-point for PTSD of 33. | Baseline, 4 weeks, 6 and 13 months post-bereavement | |
Other | Change in social support | Measured using the self-reported 8-item NIH toolbox Item Bank v2.0 - Emotional Support questionnaire. Score range from 8-40; with higher score indicating better emotional support. | Baseline, 4 weeks, 6 and 13 months post-bereavement | |
Other | Change in anxiety | Measured using the self-reported 7-item Generalized Anxiety Disorder Scale (GAD-7) to assess anxiety symptoms is the last week. Total score range from 0-2; with score >9 = high anxiety | Baseline, 4 weeks, 6 and 13 months post-bereavement | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
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