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临床试验/NCT03484338
NCT03484338已完成不适用

Accelerated Resolution Therapy for Treatment of Complicated Grief in Senior Adults

University of South Florida1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2018年2月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
54
试验地点
1
主要终点
change in complicated grief symptoms

研究概览

简要总结

This study will examine whether accelerated resolution therapy (ART) is effective for the treatment of prolonged and complicated grief and associated psychological trauma among older adult hospice caregivers who have experienced the death of an immediate family member at least 12 months ago.

详细描述

ART is an evidence-based therapy for the treatment of depressive symptoms and trauma and stress-related disorders that includes the core components of trauma-focused therapy including imaging rescripting, voluntary image replacement, guided visualization with use of eye movements, desensitization and processing of distressing memories, and in-vitro exposure to future feared triggers. Mental health professionals are delivering ART in clinical practice to assist with grief; however, there is a need for formal research evaluation of the effects of ART on complicated grief and psychological distress.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adult age 60 years of age or older
  • •previous primary caregiver of immediate family member who died after enrollment in hospice with the death occurring at least 12 months prior to enrollment
  • •current symptoms indicative of proposed diagnostic criteria for complicated grief disorder, as proposed by Shear et al. (2011)
  • •current score of >25 on the 19-item Inventory of Complicated Grief
  • •current symptoms indicative of significant psychological trauma, as documented by score >33on the 20-item DSM-5 PTSD checklist (PCL-5)26 or score >4 on the PDSQ PTSD subscale
  • •denial of suicidal ideation or intent, with no evidence of psychotic behavior

排除标准

  • •engaged in another psychotherapy regimen that could also influence symptoms of PCG - - major psychiatric disorder (e.g. bipolar disorder) deemed likely to interfere with treatment delivery
  • •current substance abuse dependence (alcohol and/or drug) treatment anticipated to interfere with treatment delivery.

研究组 & 干预措施

Intervention

Experimental

干预措施: Accelerated Resolution Therapy (Behavioral)

Wait list controlled

Active Comparator

干预措施: Accelerated Resolution Therapy (Behavioral)

结局指标

主要结局

change in complicated grief symptoms

时间窗: 4 weeks, follow up at 12 weeks

Response on the 19-item Inventory of Complicated Grief (ICF) over the course of the 4-week intervention period. Scores range from 0-76 with a score \>24 indicating presence of complicated grief.

change in psychological trauma

时间窗: 4 weeks, follow up at 12 weeks

The PCL-5 (PTSD Patient Checklist)26 is a 20-item self-report instrument that will be used to assess the DSM-5 symptoms of PTSD (psychological trauma)(corresponding to criteria B-E). The total symptom severity score ranges from 0 to . A diagnostic cut-point for PTSD of 33 has been recommended. In addition, it is generally accepted that a reduction of 10 points or more on the PCL-5 is indicative of statistical and clinically meaningful improvement.

change in depressive symptoms

时间窗: 4 weeks, follow up at 12 weeks

The Center for Epidemiologic Studies Depression Scale(CES-D)37is a widely used 20-item scale that has proven useful both as a screening instrument to detect individuals at risk for depression, and to measure the symptoms of depression.

次要结局

  • change in stress response(weekly pre to post ART and over the 4 week intervention period)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kevin Kip

Distinguished Professor

University of South Florida

研究点 (1)

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