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临床试验/NCT02279290
NCT02279290已完成不适用

Using CBT to Probe Psychobiobehavioral Resilience to Post-trauma Psychopathology

Rush University Medical Center2 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2015年7月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
58
试验地点
2
主要终点
Extinction learning will be analyzed using the fear potentiated startle data from a fear conditioning paradigm.

研究概览

简要总结

This randomized controlled trial uses a modularized cognitive behavioral resilience training (MCBRT) intervention to probe risk and resilience mechanisms linked to post-trauma psychopathology. Ninety participants with a history of interpersonal trauma during childhood or adolescence and mild to moderate distress will be randomized to MCBRT or a health education control condition. The primary aims of this proposal are to examine whether individuals who receive MCBRT demonstrate increases in psychological resilience, biological resilience, and extinction learning compared to those in the control group. This study will also explore associations between these psychobiobehavioral risk and resilience factors.

研究设计

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

入排标准

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

入选标准

  • 18 years of age or older
  • fluent in English
  • history of childhood interpersonal trauma (e.g., sexual assault, physical assault, witnessing assault before age 18)
  • mild to moderate distress indicated by a score of 10-20 on the depression scale, 8-14 on the anxiety scale, or 15-25 on the stress scale of the DASS-21.

排除标准

  • severe distress indicated by a score >20 on the depression scale, >14 on the anxiety scale, or >25 on the stress scale of the DASS-21
  • DSM-5 criterion A trauma in the past month
  • color blindness based on self-report (because of inability to complete the fear conditioning task)
  • auditory impairment based on audiometer screening (because of inability to complete the fear conditioning task)
  • lifetime psychotic or bipolar disorder
  • substance abuse or dependence within past 6 months
  • concurrent psychotherapy initiated within 3 months of randomization
  • ongoing psychotherapy of any duration directed toward treatment of trauma-related psychopathology (e.g., CBT)
  • must be on a stable dose of psychotropic or adrenergically-active medications (e.g., beta blockers) for at least 6 weeks prior to eligibility screening
  • mental retardation or significant cognitive impairment
  • serious medical illness or instability for which hospitalization may be likely within the next year
  • significant suicidal ideation indicated by "yes" on Columbia Suicide Severity Rating Scale item 4 (active suicidal ideation with some intent to act) or enacted suicidal behaviors within 6 months prior to eligibility
  • current legal actions related to trauma.

结局指标

主要结局

Extinction learning will be analyzed using the fear potentiated startle data from a fear conditioning paradigm.

时间窗: 0-9 weeks

Difference between the interventions in the change of extinction learning from pre to post intervention.

Psychological resilience outcomes include emotion regulation (DERS), hardiness (CD-RISC), optimism (LOT-R), perceived control (SMS), social support (MSPSS), and task-oriented coping (CISS-SFT).

时间窗: 0 - 9 weeks

Difference between the interventions in the change of psychological resilience from pre to post intervention.

Biological resilience outcomes include neuropeptide Y [NPY], dehydroepiandrosterone [DHEA], allopregnanolone [ALLO] taken from a blood draw.

时间窗: 0-9 weeks

Difference between the interventions in the change of biological resilience from pre to post intervention.

次要结局

未报告次要终点

研究者

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

Alyson Zalta

Assistant Professor

University of California, Irvine

研究点 (2)

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