Accelerated Resolution Therapy for Early Maladaptive Grief: A Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 440
- 试验地点
- 4
- 主要终点
- Changes in pre-loss grief
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Accelerated Resolution Therapy Group
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)
干预措施: Accelerated Resolution Therapy (Behavioral)
Information and Support Group
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.
干预措施: Information and Support (Other)
结局指标
主要结局
Changes in pre-loss grief
时间窗: Baseline, 4 weeks
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.
Changes in prolonged grief disorder
时间窗: 6 and 13 months post-bereavement
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.
Changes in clinical measure of prolonged grief disorder
时间窗: 6 and 13 months post-bereavement
Measured by 31-item Structured Clinical Interview for Prolonged Grief Disorder (SCI-P) administered by healthcare professional. Higher scores = higher complicated grief symptoms.
次要结局
未报告次要终点
研究者
Cindy Tofthagen
Principal Investigator
Mayo Clinic