Assessing a Combined Ketamine and Online Cognitive Behavioural Therapy Intervention for Treatment Resistant Post-Traumatic Stress Disorder
试验速览
- 阶段
- 2 期
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Change in Scores on the Clinician Administered PTSD Scale for DSM-5
研究概览
简要总结
An open label RCT assessing the efficacy of a combined treatment approach for PTSD, using Ketamine infusions and online Cognitive Behavioural Therapy.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Ketamine + eCBT
Over 12 weeks, participants receive weekly sessions of asynchronous online cognitive-behavioural therapy as well as 6 sub-anesthetic infusions of Ketamine
干预措施: Ketamine (Drug)
Ketamine + eCBT
Over 12 weeks, participants receive weekly sessions of asynchronous online cognitive-behavioural therapy as well as 6 sub-anesthetic infusions of Ketamine
干预措施: Online Trauma-Focused Cognitive Behavioural Therapy (Behavioral)
结局指标
主要结局
Change in Scores on the Clinician Administered PTSD Scale for DSM-5
时间窗: 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.
次要结局
- Change in Scores on the Montgomery Asberg Depression Rating Scale(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(0 weeks from start, 4 weeks from start, 8 weeks from start, and 12 weeks from start)
- Change in Scores on the Sheehan Disabilities Scale(0 weeks from start, 4 weeks from start, 8 weeks from start, and 12 weeks from start)
- Change in Scores on the Global Assessment of Functioning(0 weeks from start, 4 weeks from start, 8 weeks from start, and 12 weeks from start)
研究者
Dr. Taras Reshetukha
Principle Investigator
Queen's University