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临床试验/NCT01556048
NCT01556048已完成1 期

Pilot Study of Behavioral Activation for Prolonged Grief

Anthony Papa1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2009年2月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
25
试验地点
1
主要终点
Change from Baseline in grief symptoms at weeks 12, 24, and 36 post randomization

研究概览

简要总结

The Institute of Medicine identifies Prolonged Grief (PG) as a critical under-addressed public health problem for which are no empirically supported treatments. The purpose of this application is to pilot-test Behavioral Activation (BA) therapy for PG. BA is a well supported, stand alone intervention for depression and recently applied to posttraumatic stress disorder, which reduces rumination and avoidance behaviors that otherwise thwart access to natural rewarding contingencies and resources. The treatment focuses on promoting stable, active routines, self-care behaviors, enhanced self-efficacy, and reengagement with pleasurable activities and significant social resources. Rumination, disengagement, and low self-efficacy are defining features of PG. Further, in response to loss of intimates, the key factors that differentiate resilient people from those that have difficulties adapting is the maintenance or fast resumption of social and occupational functioning. Thus, the main hypothesis of this study is that BA for PG will result in clinically significant reductions in rumination and functional disengagement. This is a preliminary small-scale pilot assessment of potential efficacy and feasibility of completing a large scale study of BA for PG.

研究设计

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

入排标准

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

入选标准

  • meet criteria for Prolonged Grief Disorder
  • must be 21 years old or older
  • if taking psychotropic medication, must have been on a stable dose for three or more months prior to study entry

排除标准

  • presence of active suicidal or homicidal ideation
  • a history of psychotic symptoms
  • current participation in psychosocial treatment focused on grief symptoms
  • active substance abuse

研究组 & 干预措施

IMMEDIATE START GROUP

Experimental

Randomized to participate in Behavioral Activation for pathological grief starting at Week 1 of entry into the study

干预措施: Behavioral Activation (Behavioral)

DELAY START GROUP

Placebo Comparator

Randomized to participate in Behavioral Activation for pathological grief starting at Week 12 of entry into the study

干预措施: Behavioral Activation (Behavioral)

结局指标

主要结局

Change from Baseline in grief symptoms at weeks 12, 24, and 36 post randomization

时间窗: Assessments occurring in Weeks 1 (Baseline), 12, 24, and 36 post randomization

Inventory of Complicated Grief-Revised

Change from Baseline in PTSD symptoms at weeks 12, 24, and 36 post randomization

时间窗: Assessments occurring in Weeks 1 (Baseline), 12, 24, and 36 post randomization

PTSD Checklist-Specific

Change from Baseline in symptoms of Major Depressive Disorder at Weeks 12, 24, and 36 post randomization

时间窗: Assessments occurring in Weeks 1 (Baseline), 12, 24, and 36 post randomization

Depression Anxiety Stress Scales

次要结局

  • Change from Baseline in levels of rumination at Weeks 12, 24, and 36 post randomization(Assessments occurring in Weeks 1 (Baseline), 12, 24, and 36 post randomization)
  • Therapy credibility and client expectancy for improvement after treatment(Assessments occurring post-treatment (12 weeks for immediate start group, 24 weeks for delay start group))

研究者

发起方
Anthony Papa
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Anthony Papa

Assistant Professor

University of Nevada, Las Vegas

研究点 (1)

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