此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

To Observe the Psychophysiological Alterations in Traumatic Stress Subjects

2021年8月10日 更新者:Shamoon Noushad、University of Karachi

Effects of the Guided Disclosure Protocol on Post-Traumatic Growth: A Randomized Control Trial Designed to Observe Psychophysiological Alterations in Traumatic Stress Subjects

This Multicenter study is planned to investigate the effectiveness of the guided disclosure protocol for the promotion of post-traumatic growth (PTG), in the traumatic stress subjects and to determine whether PTG is associated with psychophysiological alterations i.e. (C-Reactive Protein, Brain Derived Neurotropic Factor, Interlukin-6, Cortisol, Heart Rate Variability and brain waves). Study subjects meeting eligibility criteria will be randomized into two groups. Guided disclosure protocol (GDP) will be used as intervention vs the control. Blinded treatment will be provided and the subjects will be made to complete study questionnaires (Screening, Traumatic Stress Scale SSS, Trauma Symptom Checklist, Post-traumatic growth Inventory) at baseline and at post-intervention (3-months later).

研究概览

地位

完全的

干预/治疗

详细说明

Study design:

The study will be conducted as multicenter randomized controlled trial. On the basis of eligibility criteria subjects providing consent to participate in the study will be randomized into two groups, experimental group including those who receive the intervention and a control group receiving control intervention. The study outcomes will be monitored in subjects of both groups at different intervals i.e. at baseline and at 3-month follow-up (post-interventional).

Participants Subjects for the present study will be recruited from 5 centers (based in Karachi, Pakistan). The targeted population includes subjects from diverse ethnicity and considered eligible for participation in the study if they indicated in a pre-screening form that they had experienced traumatic event. These subjects will be invited to participate in the study through advertisement on notice board of each center. A written informed consent will be obtained from each study subject after providing detailed information regarding objectives of the study and its duration.

Interventions

The experimental intervention (GDP):

It includes three writing sessions of 20 minutes where the participants will be made to recall the facts regarding the traumatic event first and then the emotions triggered related to the revealed facts will be channelized. The information related to the immediate priority changes due to the revival of the traumatic history and its reflection on current feelings will be collected. Moreover, the learned coping mechanisms will also be inquired and how the traumatic event altered their vision and their personalities and how it helps in coping with future difficulties.

The original instructions will be translated into local language and altered according to the specific traumatic experience.

In the following, a fusion of the tasks concerning each of the three writing sessions is shown.

  1. Participants will be required to describe memories associated with traumatic event in a sequential order, with an objective and detached attitude
  2. They will be asked to describe

    1. Their opinion regarding the traumatic event and emotions perceived during the experience
    2. Its impact on their daily lives, and how it has altered their attitudes toward life.
  3. The actual situation will be focused, while reviving the whole traumatic event experience which aids in exploring the following aspects:

    • Present thoughts and feelings regarding the traumatic experience, and also clarify the differences between the ones felt at the time of traumatic event in comparison to the current feelings.
    • How much they understand and appreciate themselves for successfully dealing with the traumatic event
    • To what extent the traumatic event has modified their vision, attitude, knowledge, and skills, and how it can help in their future;
    • What will be their future reactions to other similar events. For the writing session it is mandatory to maintain standard experimental environment with maximum silence so that the subject can write peacefully without getting disturbed. Two weeks after the initial assessment, the first writing session will be performed followed by two sessions once every 2 weeks.

The control intervention:

In control intervention the subjects will be required to take three 20-minute writing sessions, in which they will be asked to write about their daily events of the past week, the writing must focus on the facts and highlight an objective and detached attitude. It has shown potential improvements after the guided disclosure protocol (GDP). Works through the placebo effect. Same protocol will be followed for these subjects as the one used for GDP.

A day prior to each writing session, in both conditions either experimental or control the researcher will communicate with each study subject via telephone in order to give them a reminder to perform the writing task and to check their understanding regarding the instructions given in the booklet. Details regarding the inability to contact the subject will also be recorded in the patient form.

研究类型

介入性

注册 (实际的)

246

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Sindh
      • Karachi、Sindh、巴基斯坦、78500
        • Shamoon Noushad

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 50年 (成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Must be disease free, there must be no evidence of any metastatic disease
  2. Property of written and spoken the English language.
  3. Experienced any traumatic event in the last 12 Months

Exclusion Criteria:

  1. Subjects who received a structured psychological intervention for at least 6 months during the last 3 years performed by a psychologist or psychiatrist will be excluded.
  2. Those with a codified psychiatric disorder (according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) who received Psychopharmacological treatment during the last 3 years will also be excluded from the study sample.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:The experimental intervention (GDP): It includes three writing
  1. Participants will be required to describe memories associated with traumatic event in a sequential order, with an objective and detached attitude
  2. They will be asked to describe

    1. Their opinion regarding the traumatic event and emotions perceived during the experience
    2. Its impact on their daily lives, and how it has altered their attitudes toward life.
  3. The actual situation will be focused, while reviving the whole traumatic event experience which aids in exploring the following aspects:

    • Present thoughts and feelings regarding the traumatic experience, and also clarify the differences between the ones felt at the time of traumatic event in comparison to the current feelings.
    • How much they understand and appreciate themselves for successfully dealing with the traumatic event
    • To what extent the traumatic event has modified their vision, attitude, knowledge, and skills, and how it can help in their future;
    • What will be their future reactions to other similar events.
Guided Disclosure Protocol
无干预:The control intervention:
A day prior to each writing session, the researcher will communicate with each study subject via telephone in order to give them a reminder to perform the writing task and to check their understanding regarding the instructions given in the booklet. Details regarding the inability to contact the subject will also be recorded in the patient form.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Post-Traumatic Growth (PTG)
大体时间:3 Months
Change in the Post-traumatic Growth Inventory (PTGI) will be observed among the subjects enrolled in the GDP group as compared to the control group.
3 Months

次要结果测量

结果测量
措施说明
大体时间
C- Reactive Protein (CRP)
大体时间:3 Months
Change in the CRP level will be observed among the subjects enrolled in the GDP group as compared to the control group.
3 Months
Brain-derived neurotrophic factor (BDNF)
大体时间:3 Months
Change in the BDNF level will be observed among the subjects enrolled in the GDP group as compared to the control group.
3 Months
Interleukin-6 (IL-6)
大体时间:3 Months
Change in the IL-6 level will be observed among the subjects enrolled in the GDP group as compared to the control group.
3 Months
Glutamate
大体时间:3 Months
Change in the Glutamate level will be observed among the subjects enrolled in the GDP group as compared to the control group.
3 Months
Cortisol
大体时间:3 Months
Change in the Cortisol level will be observed among the subjects enrolled in the GDP group as compared to the control group.
3 Months
Alpha waves
大体时间:3 Months
Change in the Brain waves (Alpha waves) will be observed among the subjects enrolled in the GDP group as compared to the control group.
3 Months
Heart Rate Variability
大体时间:3 Months
Change in the Heart Rate Variability will be observed among the subjects enrolled in the GDP group as compared to the control group.
3 Months
Beta waves
大体时间:3 Months
Change in the Brain waves (Beta waves) will be observed among the subjects enrolled in the GDP group as compared to the control group.
3 Months

其他结果措施

结果测量
措施说明
大体时间
Trauma Symptom Checklist 40 (TSC-40)
大体时间:3 Months
Change in the Trauma Symptom Checklist 40 (TSC-40) will be observed among the subjects enrolled in the GDP group as compared to the control group.
3 Months
Traumatic Stress Scale (Sadaf Stress Scale)
大体时间:3 Months
Change in the Traumatic Stress Scale will be observed among the subjects enrolled in the GDP group as compared to the control group.
3 Months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2019年12月2日

初级完成 (实际的)

2021年8月10日

研究完成 (实际的)

2021年8月10日

研究注册日期

首次提交

2019年12月24日

首先提交符合 QC 标准的

2019年12月31日

首次发布 (实际的)

2020年1月6日

研究记录更新

最后更新发布 (实际的)

2021年8月11日

上次提交的符合 QC 标准的更新

2021年8月10日

最后验证

2021年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅