Hybrid Dialectical Behavior Therapy for Veterans to Further Reduce Emotion Regulation Problems and Trauma Symptoms (REFRESH)
2026年6月11日 更新者：Arkin
REfreshment of Dialectical Behaviour Therapy for Veterans to Further Reduce Symptoms and Prevent Relapse of Post-traumatic Stress Disorder and Emotion Regulation Symptoms by Guided Self-Help
Around 10% of post-active veterans experience post-traumatic stress disorder (PTSD) many years post-mission.
PTSD in veterans is frequently associated with challenges in emotion regulation, aggression, suicidality, and financial and psychosocial stress.
In 2018, a 12-week clinical treatment programme, the Veterans Intensive Treatment Unit (VIBU), was developed for veterans experiencing these psychiatric symptoms, for whom conventional treatments had proven ineffective.
The VIBU provides patients with trauma-focused and dialectical behaviour therapy (DBT).
A recent study revealed that the VIBU was effective in reducing psychiatric symptoms.
However, a recurrence of symptoms was observed in patients a few months after discharge.
Consequently, an aftercare programme consisting of hybrid DBT is offered to consolidate and repeat the DBT skills and apply them in daily life.
研究概览
研究类型
介入性
注册 (估计的)
24
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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North Holland
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Amstelveen、North Holland、荷兰、1186 AM
- 招聘中
- Sinai Center
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接触：
- Kathleen Thomaes, Senior researcher
- 电话号码：020 545 7200
- 邮箱：refreshonderzoek@sinaicentrum.nl
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接触：
- Mariejean Albers, MSc
- 邮箱：mariejean.albers@sinaicentrum.nl
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首席研究员：
- Kathleen Thomaes, Senior researcher
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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:
- Adult veteran (18 years or older), treated at Sinai Center, with knowledge of DBT
- Primairy diagnosis of PTSD, determined with CAPS-5, resulting from war-related traumas
- Stable for four weeks on their medication (type and doses)
- Able to to do online homework assignments and communicate with their therapist via an eHealth platform
- Dutch speaking
Exclusion Criteria:
- Chronic psychosis (psychotic features as comorbidity from PTSD is allowed) or bipolar disorder type 1
- IQ below 80 or cognitive disorders
- Severe self-harming behaviour, such as auto-mutilation or suicidal ideations as main problem
- Following day treatments or other intensive treatment for residual symptoms
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：随机化
- 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：Hybrid DBT
All participants will follow the same hybrid DBT program (i.e., group sessions, individual sessions and online homework assignments).
Randomization will determine the length of the waiting period between baseline and start of the intervention (i.e., hybrid DBT).
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Hybrid DBT will be provided to veterans who have followed a 3-month inpatient DBT treatment.
The hybrid DBT will include face-to-face skill groups, online individual sessions and online homework assignements.
其他名称：
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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 |
|---|---|---|
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PTSD Checklist for the DSM-5 (PCL-5)
大体时间：From the baseline to the end of the follow-up period (between 12-17 months)
|
One of the two main outcomes of this study is PTSD symptom score.
The self-report questionnaire contains 20 questions with answer options ranging from '0 = Not at all' to '4 = Extremely', resulting in a score between 0-80.
A higher score indicates more likelyhood of having PTSD.
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From the baseline to the end of the follow-up period (between 12-17 months)
|
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Difficulties in Emotion Regulation Scale Short Form (DERS-SF)
大体时间：From the baseline to the end of the follow-up period (between 12-17 months)
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One of the two main outcomes of this study is emotion dysregulation severity.
The self-report questionnaire contains 18 questions with answer options from '1 = Almost never' to '5 = Almost always', resulting in a score between 18-90.
A higher score indicates more difficulties with regulation emotions.
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From the baseline to the end of the follow-up period (between 12-17 months)
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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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REFRESH - monitoring
大体时间：From enrollment to (favourably) the end of the follow-up period (between 12-17 months)
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Weekly short questionnaire (i.e., 10 questions) specifically tailored to this population to monitore PTSD, emotion regulation, substance use and DBT skills.
Answer options range from '1 = Totally disagree' to '10 = Totally agree', resulting in a score between 10-100.
A higher score means a worse outcome.
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From enrollment to (favourably) the end of the follow-up period (between 12-17 months)
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Outcome Questionnaire (OQ-30.2)
大体时间：From the baseline to the end of the follow-up period (between 12-17 months)
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This self-report questionnaire gives an indication of overall psychiatric symptoms and entails 30 items.
Answers options go from '0 = almost never' to '4 = almost alywas'.
The score ranges between 0-120, with a higher score indicating a worse outcome.
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From the baseline to the end of the follow-up period (between 12-17 months)
|
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Alcohol Use Disorders Identification Test (AUDIT)
大体时间：From the baseline to the end of the follow-up period (between 12-17 months)
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This self-report questionnaire contains 10 items with answer options from '0 = never' to '4 = high usage', resulting in a score between 0-40.
A higher score indicates having alcohol problems.
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From the baseline to the end of the follow-up period (between 12-17 months)
|
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Drug Use Disorders Identification Test (DUDIT)
大体时间：From the baseline to the end of the follow-up period (between 12-17 months)
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This self-report questionnaire contains 11 items with answer options from '0 = never' to '4 = high usage', resulting in a score between 0-40.
A higher score indicates having drug problems.
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From the baseline to the end of the follow-up period (between 12-17 months)
|
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Individual Recovery Outcome Counter (i-ROC)
大体时间：From the baseline to the end of the follow-up period (between 12-17 months)
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This questionnaires measures wellbeing outcomes.
This self-report questionnaire of 12 items uses answer options from '1 = Never' to '6 = Always', resulting in a score ranging between 12-72.
A higher score indicates a better outcome.
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From the baseline to the end of the follow-up period (between 12-17 months)
|
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General Self-Efficacy Scale (GSES)
大体时间：From the baseline to the end of the follow-up period (between 12-17 months)
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This questionnaire measures self-efficacy.
This self-report questionnaire of 10 items, with answer options from '1 = Not at all true' to '4 = Exactly true', with scores ranging from 10-40.
A higher score indicates more self-efficacy.
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From the baseline to the end of the follow-up period (between 12-17 months)
|
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Dialectical behavioral therapy skills (DBT-skills)
大体时间：From the baseline to the end of the follow-up period (between 12-17 months)
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This questionnaire asks participants about their use of DBT skills.
This self-report questionnaire of 17 items has answer options from '1 = never' to '5 = often', giving a score rangen between 17-85.
A higher score indicates a positive outcome.
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From the baseline to the end of the follow-up period (between 12-17 months)
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Level of Personality Functioning Scale (LPFS 2.0)
大体时间：From the baseline to the end of the follow-up period (between 12-17 months)
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This questionnaire measures the level of personality functioning.
This self-report questionnaire contains 12 items, with answers ranging from '1 = not often true' to '4 = often true', resulting in a score between 12-48.
A higher score indicates a worse outcome.
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From the baseline to the end of the follow-up period (between 12-17 months)
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Inventarisatielijst Sociale Betrokkenheid (ISB)
大体时间：From the baseline to the end of the follow-up period (between 12-17 months)
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This questionnaire is about social wellbeing.
This self-report questions contains 11 items, with results from '1 = almost never' to '4 = almost always', resulting in a score between 11-44.
A higher score indicates a positive outcome.
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From the baseline to the end of the follow-up period (between 12-17 months)
|
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Aggression questionnaire (AGQ)
大体时间：From the baseline to the end of the follow-up period (between 12-17 months)
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This questionnaire measures different forms of aggression.
This self-report questionnaire contains 29 items, with answer from '1 = Extremely uncharacteristic' to '5 = Extremely characteristic', resulting in a score between 29-145.
A higher score indicates a worse outcome.
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From the baseline to the end of the follow-up period (between 12-17 months)
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Suicidal Ideation Attributes Scale (SIDAS)
大体时间：From the baseline to the end of the follow-up period (between 12-17 months)
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This questionnaire measures suicidal ideation.
This self-report questionnaire contains 5 items, with answer from '0 = Not at all' to '10 = Completely', resulting in a score between 0-50.
A higher score indicates a higher level of suicidal ideation.
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From the baseline to the end of the follow-up period (between 12-17 months)
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Non-Suicidal Self-Injury Assement Tool screener (NSSI-AT screener)
大体时间：From the baseline to the end of the follow-up period (between 12-17 months)
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This questionnaire measures self-injurious behavior.
This self-report questionnaire contains 7 items asking about the frequency and severity of self-injurious behaviour.
There is no scoring.
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From the baseline to the end of the follow-up period (between 12-17 months)
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Childhood Trauma Questionnaire (CTQ)
大体时间：At baseline
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This questionnaire assess childhood maltreatment.
This self-report questionnaire contains 28 items, with answers from '1 = Never true' to '5 = Very often true', resulting in a score between 28-140.
A higher score indicate a worse outcome.
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At baseline
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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。
赞助
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)
2026年6月1日
初级完成 (估计的)
2028年9月1日
研究完成 (估计的)
2028年10月1日
研究注册日期
首次提交
2026年2月23日
首先提交符合 QC 标准的
2026年6月11日
首次发布 (实际的)
2026年6月17日
研究记录更新
最后更新发布 (实际的)
2026年6月17日
上次提交的符合 QC 标准的更新
2026年6月11日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- REFRESH
- NL-010470 (注册表标识符：METC Amsterdam)
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
Very sensitive personal information.
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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.