Brief SEE FAR CBT Intervention Compared With Treatment as Usual for Adults With PTSD
2026年7月13日 更新者：Community Stress Prevention Center
A Clinical Study Evaluating the Effects of a Brief SEE FAR CBT Intervention Compared With Dynamic Psychotherapy Treatment as Usual on Psychological Outcomes in Adults With Posttraumatic Stress Disorder
This clinical intervention study evaluates a newly developed Brief SEE FAR CBT protocol for adults aged 18 years and older with posttraumatic stress disorder (PTSD), compared with dynamic psychotherapy treatment as usual.
Participants in the Brief SEE FAR CBT group will receive 6 focused sessions emphasizing intrusive PTSD symptoms and will then continue to complete the full 12-session SEE FAR CBT protocol.
Participants in the control group will receive dynamic psychotherapy as treatment as usual.
Psychological outcomes will be assessed using self-report questionnaires at four time points: baseline, after 6 sessions, after 12 sessions, and at a 3-month follow-up.
The study aims to examine changes in PTSD symptoms, anxiety, depression, perceived stress, resilience, somatic symptoms, sleep quality, and related psychological outcomes over the course of treatment and follow-up.
研究概览
地位
招聘中
条件
研究类型
介入性
注册 (估计的)
60
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。
学习联系方式
- 姓名：Meital Mashash, PhD
- 电话号码：972-50-2888052
- 邮箱：meitalm@icspc.org
研究联系人备份
- 姓名：Sivan Raz, PhD
- 电话号码：972-54-6634301
- 邮箱：sivanra@telhai.ac.il
学习地点
-
-
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Sha'ar Hanegev、以色列
- 招聘中
- The Center for Psychological Services Sha'ar Hanegev
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接触：
- Tal Eilon
- 电话号码：972-77-9802751
- 邮箱：tale@mpsy.org.il
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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
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria
Participants must meet all of the following criteria:
- Age 18 years or older
- PTSD symptoms, defined as a PCL-5 score of 30-60
- Hebrew-speaking
- Able to provide informed consent
- Willing and able to participate in the assigned psychological intervention and complete study questionnaires at baseline, after 6 sessions, after 12 sessions, and at 3-month follow-up Exclusion Criteria
Participants will be excluded if they meet any of the following criteria:
- Pregnancy at the time of enrollment, due to the potential influence of pregnancy and childbirth during the treatment or follow-up period on psychological outcomes
- Currently receiving psychotherapy of any type that began less than 3 months prior to enrollment
- Initiation of psychiatric medication less than 3 months prior to enrollment
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：非随机化
- 介入模型：并行分配
- 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：Brief SEE FAR CBT Intervention
Participants in this arm will receive 6 focused sessions of Brief SEE FAR CBT, a newly developed protocol emphasizing intrusive PTSD symptoms.
After completing the 6 focused sessions, participants will continue to complete the full 12-session SEE FAR CBT protocol.
|
Brief SEE FAR CBT is a focused trauma-oriented cognitive-behavioral intervention based on the SEE FAR CBT approach.
The brief protocol consists of 6 sessions delivered approximately once weekly, with emphasis on intrusive PTSD symptoms.
Participants will then continue treatment to complete the full 12-session SEE FAR CBT protocol.
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实验性的：Dynamic Psychotherapy Treatment as Usual
Participants in this arm will receive dynamic psychotherapy as treatment as usual, delivered approximately once weekly.
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Participants will receive dynamic psychotherapy as treatment as usual, delivered approximately once weekly.
This comparison condition represents the standard psychological treatment provided to participants in this clinical setting.
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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 |
|---|---|---|
|
Change in PTSD symptoms
大体时间：Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
|
PTSD Checklist for DSM-5 (PCL-5) PTSD symptoms will be assessed using the PCL-5.
Total scores range from 0 to 80, with higher scores indicating greater PTSD symptom severity.
Change in PCL-5 total score will be examined from baseline to after 6 sessions, from baseline to after 12 sessions, from baseline to 3-month follow-up, from after 6 sessions to after 12 sessions, and from after 12 sessions to 3-month follow-up.
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Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
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Change in anxiety symptoms
大体时间：Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
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Generalized Anxiety Disorder-7 (GAD-7) Anxiety symptoms will be assessed using the GAD-7.
Total scores range from 0 to 21, with higher scores indicating greater anxiety symptom severity.
Change in GAD-7 total score will be examined from baseline to after 6 sessions, from baseline to after 12 sessions, from baseline to 3-month follow-up, from after 6 sessions to after 12 sessions, and from after 12 sessions to 3-month follow-up.
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Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in depressive symptoms
大体时间：Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
|
Patient Health Questionnaire-9 (PHQ-9) Depressive symptoms will be assessed using the PHQ-9.
Total scores range from 0 to 27, with higher scores indicating greater depressive symptom severity.
Change in PHQ-9 total score will be examined across the four study assessment points.
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Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
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Change in perceived stress
大体时间：Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
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Perceived Stress Scale (PSS) Perceived stress will be assessed using the PSS.
Total scores range from 0 to 40, with higher scores indicating greater perceived stress.
Change in PSS total score will be examined across the four study assessment points.
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Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
|
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Change in resilience
大体时间：Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
|
Connor-Davidson Resilience Scale (CD-RISC) esilience will be assessed using the CD-RISC.
Total scores range from 0 to 40, with higher scores indicating greater resilience.
Change in CD-RISC total score will be examined across the four study assessment points.
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Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
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Change in somatic symptoms
大体时间：Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
|
Patient Health Questionnaire-15 (PHQ-15) Somatic symptoms will be assessed using the PHQ-15.
Total scores range from 0 to 30, with higher scores indicating greater somatic symptom severity.
Change in PHQ-15 total score will be examined across the four study assessment points.
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Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
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Change in trauma-related use of imagination and coping
大体时间：Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
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FRAME Trauma-related use of imagination and coping will be assessed using the FRAME questionnaire.
The FRAME is a 21-item measure of fantastic reality ability, defined as the capacity to use imagination in response to stress or trauma.
Items are rated on a 1-7 Likert scale, and mean scores range from 1 to 7, with higher scores indicating greater fantastic reality ability.
Change in FRAME score will be examined across the four study assessment points.
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Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
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Change in sleep quality
大体时间：Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
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Brief Version of the Pittsburgh Sleep Quality Index Sleep quality will be assessed using the brief version of the Pittsburgh Sleep Quality Index.
Change in sleep quality score will be examined across the four study assessment points.
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Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
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Change in PTSD-related functional impairment
大体时间：Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
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PTSD-related functional impairment will be assessed using the functional impairment section of the Posttraumatic Diagnostic Scale (PDS).
This section includes 7 items assessing the extent to which PTSD-related problems interfered with work, relationships, leisure activities, family relationships, sex life, general life satisfaction, and overall functioning during the past two weeks.
Items are rated from 0 to 4, and total scores range from 0 to 28, with higher scores indicating greater functional impairment.
Change in functional impairment score will be examined across the four study assessment points.
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Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of 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：Meital Mashash, PhD、Community Stress Prevention Center
- 首席研究员：Sivan Raz, PhD、Tel Hai College
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 (估计的)
2026年7月1日
初级完成 (估计的)
2027年12月1日
研究完成 (估计的)
2028年3月1日
研究注册日期
首次提交
2026年7月1日
首先提交符合 QC 标准的
2026年7月13日
首次发布 (实际的)
2026年7月17日
研究记录更新
最后更新发布 (实际的)
2026年7月17日
上次提交的符合 QC 标准的更新
2026年7月13日
最后验证
2026年6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
- BRIEF-SEE-FAR-CBT-PTSD-2026
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
Individual participant data will not be shared due to the sensitive clinical nature of the data and participant privacy considerations.
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.