Cognitive Processing Therapy for Syrian Patients With PTSD (CPT4Syrians)
2021年9月1日 更新者：Amani Safwat Albrazi、British University In Egypt
Cognitive Processing Therapy for the Treatment of Post-Traumatic Stress Disorder in Syrian Patients
Background: Studies among Syrian refugees showed high prevalence rates of PTSD.
The objective of the present study was to investigate the effectiveness of Cognitive Processing Therapy (CPT) in treating patients with posttraumatic stress disorder (PTSD) using a clinical trial.
Methods: Data will be obtained through interviewing patients seeking for PTSD treatment.
Patients will be interviewed by a clinician and asked to complete the Clinician-Administered PTSD Scale (CAPS-5), Beck Depression Inventory (BDI-II), Beck Anxiety Inventory (BAI).
Assessments will be conducted at baseline, 3-, and 12-months posttreatment.
The primary outcomes will be the scores of CAPS, BDI-II, and BAI.
Results: we predict that CPT will result in greater reductions in CAPS scores.
研究概览
详细说明
Although individuals with PTSD experience significant suffering, disability, and a challenging clinical course, there are still significant gaps in the evidence addressing effective treatment options.
Therefore, in the current study CPT will determine the effectiveness in treating Syrian patients with PTSD.
Current study significantly adds to the existing literature.
It is a novel study in Egypt and adds to the literature.
研究类型
介入性
注册 (实际的)
94
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
-
-
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Cairo、埃及、11837
- The British University in Egypt
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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 65年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria Their nationalities are Syrians
- age older than 18 years and younger than 65,
- patients meeting current diagnostic criteria for PTSD as defined in DSM-5
- have a good knowledge of English-language (reading, writing, and comprehension) because all assessments and therapy materials were in English
Exclusion Criteria
- having mental retardation
- having schizophrenia (or any other psychotic disorders).
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：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：CPT Group
Cognitive Processing Therapy (CPT) is employed.
Each patient will attend 12 individual sessions with the therapist.
The sessions will be on the weekly basis.
The standard manual of CPT (Resick et al., 2016) is going to be employed.
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Cognitive processing therapy (CPT) (Resick et al., 2016) which is a specific type of cognitive behavioral therapy that has been effective in reducing symptoms of Post-Traumatic Stress Disorder (PTSD) that may have developed after experiencing a variety of traumatic events including child abuse, emotional abuse, combat, rape war, and natural disasters.
CPT helps patients learn how to challenge and modify unhelpful beliefs related to the trauma and emotional pain.
In so doing, the client creates a new understanding and conceptualization of the traumatic event so that it reduces its ongoing negative effects on current life.
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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 |
|---|---|---|
|
assessing change in CAPS-5 scores between three time points
大体时间：baseline (pre-intervention), posttreatment (immediately after the intervention), 12-months after the intervention
|
Clinician-Administered PTSD Scale (CAPS-5; Weathers et al., 2015) is currently the gold- standard assessment for PTSD and is used to assess PTSD's symptoms at pre-intervention, immediately post- intervention, and 12-month after the intervention.
This 30-item structured interview was developed by staff at the U.S. Department of Veterans Affairs National Center for PTSD.
The interview can generally be administered in 45-60 minutes.
Each question in CAPS asks about both the frequency and the severity of each PTSD symptom.
These questions are split into categories.
Each criterion has several questions, and scores for each criterion are added up at the end.
The CAPS-5 has demonstrated strong psychometric properties (Weathers, et al., 2018).
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baseline (pre-intervention), posttreatment (immediately after the intervention), 12-months after the intervention
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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assessing change in Beck Depression Inventory (BDI-II) scores between three time points
大体时间：baseline (pre-intervention), posttreatment (immediately after the intervention), 12-months after the intervention
|
Beck Depression Inventory (BDI-II): was used to evaluate the change in the severity of depressive symptoms between three time points.
BDI-II is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression (Beck, et al., 1996).
The BDI takes approximately 10 minutes to complete.
Depression levels were defined as follows: minimal range = 0- 13, mild depression = 14-19, moderate depression = 20-28, and severe depression = 29- 63.
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baseline (pre-intervention), posttreatment (immediately after the intervention), 12-months after the intervention
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assessing change in Beck Anxiety Inventory (BAI) scores between three time points
大体时间：baseline (pre-intervention), posttreatment (immediately after the intervention), 12-months after the intervention
|
Beck Anxiety Inventory (BAI): was used to evaluate the change in the severity of anxiety severity between three time points. BAI was developed by Dr. Aaron T. Beck and it is a brief measure of anxiety with a focus on somatic symptoms of anxiety such as nervousness, dizziness, inability to relax (Beck et al., 1988). It has a total of 21 items that takes approximately 10-15 minutes to complete. Answers are on a 4-point Likert scale and range from 0 (not at all) to 3 (severely). The values for each item are summed yielding an overall or total score for all 21 symptoms that can range between 0 and 63 points. A total score of 0 - 7 is interpreted as a "Minimal" level of anxiety; 8 - 15 as "Mild"; 16 -25 as "Moderate", and 26 - 63 as "Severe". |
baseline (pre-intervention), posttreatment (immediately after the intervention), 12-months after the intervention
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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。
调查人员
- 首席研究员：Amani S Elbarazi, Ph.D.、The British University in Egypt
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)
2017年1月1日
初级完成 (实际的)
2020年12月1日
研究完成 (实际的)
2021年1月1日
研究注册日期
首次提交
2021年8月17日
首先提交符合 QC 标准的
2021年9月1日
首次发布 (实际的)
2021年9月2日
研究记录更新
最后更新发布 (实际的)
2021年9月2日
上次提交的符合 QC 标准的更新
2021年9月1日
最后验证
2021年9月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- BritishUE20-21
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
individual participant data (IPD) will be available to other researchers
IPD 共享时间框架
January 2022
IPD 共享访问标准
Direct access to the patients' data will be granted to authorized representatives from the Sponsor and host hospital for monitoring and/or audit of the study to ensure compliance with regulations.
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 企业社会责任
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.