Combined Ketamine and eCBT Intervention for PTSD
2022年8月8日 更新者：Dr. Taras Reshetukha、Queen's University
Assessing a Combined Ketamine and Online Cognitive Behavioural Therapy Intervention for Treatment Resistant Post-Traumatic Stress Disorder
An open label RCT assessing the efficacy of a combined treatment approach for PTSD, using Ketamine infusions and online Cognitive Behavioural Therapy.
研究概览
详细说明
OBJECTIVES
(i) To introduce a previously untreated patient population with PTSD to new therapeutic options.
(ii) To provide new insights into the functional role of Glutamate in affective disorders as well as in learning and memory.
(iii) To explore the utility of pharmacologically-enhanced psychotherapy.
OUTLINE
The present study is an open label randomized control trial assessing the efficacy of a combined treatment of sub-anaesthetic IV Ketamine in conjunction with online CBT (eCBT). In the study, 16 participants with refractory PTSD will be assigned either to an experimental group receiving a combination of Ketamine and eCBT over 12 weeks, or they will be assigned to a 12-week control group. Both groups will be assessed for symptoms of PTSD and comorbid disorders before treatment, at 2 midway points (4 and 8 weeks), and at the end of the 12 week experimental period. Symptoms of PTSD and comorbid disorders for participants in the experimental group are expected to improve significantly more than participants in the control.
研究类型
介入性
注册 (预期的)
16
阶段
- 阶段2
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：Aaron E Philipp-Muller, B.Sc.
- 电话号码：416-939-3164
- 邮箱：19aepm1@queensu.ca
学习地点
-
-
Ontario
-
Kingston、Ontario、加拿大、K7L 3N6
- 招聘中
- Queen's University
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接触：
- Aaron Philipp-Muller, B.Sc.
- 电话号码：4169393164
- 邮箱：19aepm1@queensu.ca
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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
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Diagnosis of PTSD by a psychiatrist on the team using the Clinician Administered PTSD Scale (CAPS-5) with a score of at least 50 and a medium presentation.
- Patients will have received at least 2 different types of prior treatment, both of which produced less than a 50% reduction in the participant's symptoms.
- Participants with hypertension or cardiovascular disease must be receiving stable treatment to participate.
- Participants must speak and read English, and will have consistent and reliable access to the internet.
- Patients with suicidal ideation will be included.
- Patients with a history of substance abuse will be included (except for opioid use disorder).
Exclusion Criteria:
Hypomanic/manic episodes, bipolar disorder, acute psychosis, opioid use disorder, treatment with Naltrexone, pregnancy, postpartum, breastfeeding, untreated hypertension, cardiovascular disease, ASPD, active homicidal ideation, and general noncompliance with the study protocol.
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 |
|---|---|
|
实验性的：Ketamine + eCBT
Over 12 weeks, participants receive weekly sessions of asynchronous online cognitive-behavioural therapy as well as 6 sub-anesthetic infusions of Ketamine
|
Patients will receive 6 sub-anesthetic IV ketamine infusions over 8 weeks, each one lasting 40 minutes.
其他名称：
Participants will enrol in a 12-week online CBT program mirroring in-person trauma-focused CBT.
其他名称：
|
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无干预：Control
Participants are in a control condition receiving treatment as usual, during which time they will not receive the experimental treatment and will have no change in their treatment regimen.
|
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 Scores on the Clinician Administered PTSD Scale for DSM-5
大体时间：0 weeks from start, 4 weeks from start, 8 weeks from start, and 12 weeks from start
|
Assessment of PTSD symptoms for diagnosis and severity; score representing the mildest/lack of symptoms: 0; score representing the most severe symptoms: 120.
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0 weeks from start, 4 weeks from start, 8 weeks from start, and 12 weeks from start
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Scores on the Montgomery Asberg Depression Rating Scale
大体时间：0 weeks from start, 4 weeks from start, 8 weeks from start, and 12 weeks from start
|
Measure of depression; score representing the mildest/lack of symptoms: 0; score representing the most severe symptoms: 60.
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0 weeks from start, 4 weeks from start, 8 weeks from start, and 12 weeks from start
|
|
Change in Scores on the Columbia Suicide Severity Rating Scale
大体时间：0 weeks from start, 4 weeks from start, 8 weeks from start, and 12 weeks from start
|
Measuring thoughts, feelings, and behaviours associated with suicide; score representing the mildest/lack of symptoms: 0; score representing the most severe symptoms: 6.
|
0 weeks from start, 4 weeks from start, 8 weeks from start, and 12 weeks from start
|
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Change in Scores on the Sheehan Disabilities Scale
大体时间：0 weeks from start, 4 weeks from start, 8 weeks from start, and 12 weeks from start
|
A brief, patient rated measure of disability and impairment; score representing the mildest/lack of symptoms: 0; score representing the most severe symptoms: 44.
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0 weeks from start, 4 weeks from start, 8 weeks from start, and 12 weeks from start
|
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Change in Scores on the Global Assessment of Functioning
大体时间：0 weeks from start, 4 weeks from start, 8 weeks from start, and 12 weeks from start
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Assessing the patient's overall capacity to handle life's challenges; score representing the mildest/lack of symptoms: 100; score representing the most severe symptoms: 1.
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0 weeks from start, 4 weeks from start, 8 weeks from start, and 12 weeks from start
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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：Taras Reshetukha, MD、Queen's University
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
- Feder A, Parides MK, Murrough JW, Perez AM, Morgan JE, Saxena S, Kirkwood K, Aan Het Rot M, Lapidus KA, Wan LB, Iosifescu D, Charney DS. Efficacy of intravenous ketamine for treatment of chronic posttraumatic stress disorder: a randomized clinical trial. JAMA Psychiatry. 2014 Jun;71(6):681-8. doi: 10.1001/jamapsychiatry.2014.62.
- Bisson JI, Roberts NP, Andrew M, Cooper R, Lewis C. Psychological therapies for chronic post-traumatic stress disorder (PTSD) in adults. Cochrane Database Syst Rev. 2013 Dec 13;2013(12):CD003388. doi: 10.1002/14651858.CD003388.pub4.
- Alavi N, Stefanoff M, Hirji A, Khalid-Khan S. Cognitive Behavioural Therapy through PowerPoint: Efficacy in an Adolescent Clinical Population with Depression and Anxiety. Int J Pediatr. 2018 Nov 8;2018:1396216. doi: 10.1155/2018/1396216. eCollection 2018.
- Girgenti MJ, Ghosal S, LoPresto D, Taylor JR, Duman RS. Ketamine accelerates fear extinction via mTORC1 signaling. Neurobiol Dis. 2017 Apr;100:1-8. doi: 10.1016/j.nbd.2016.12.026. Epub 2016 Dec 30.
- Pradhan B, Mitrev L, Moaddell R, Wainer IW. d-Serine is a potential biomarker for clinical response in treatment of post-traumatic stress disorder using (R,S)-ketamine infusion and TIMBER psychotherapy: A pilot study. Biochim Biophys Acta Proteins Proteom. 2018 Jul;1866(7):831-839. doi: 10.1016/j.bbapap.2018.03.006. Epub 2018 Mar 18.
- Philipp-Muller AE, Reshetukha T, Vazquez G, Milev R, Armstrong D, Jagayat J, Alavi N. Combining Ketamine and Internet-Based Cognitive Behavioral Therapy for the Treatment of Posttraumatic Stress Disorder: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Jul 20;10(7):e30334. doi: 10.2196/30334.
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)
2021年8月1日
初级完成 (预期的)
2024年3月31日
研究完成 (预期的)
2024年3月31日
研究注册日期
首次提交
2020年11月19日
首先提交符合 QC 标准的
2021年2月23日
首次发布 (实际的)
2021年2月25日
研究记录更新
最后更新发布 (实际的)
2022年8月11日
上次提交的符合 QC 标准的更新
2022年8月8日
最后验证
2022年8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
- 14521759
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
All participant screening and assessment data will be made available once deidentified.
IPD 共享时间框架
Made available in June 2024.
No end date.
IPD 共享访问标准
Open access
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 分析代码
- 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
是的
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
是的
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.