The Predictive Role of Immune-inflammatory Biomarkers and Their Interaction With the Oxytocin System in Trauma-related Psychotherapy Responsiveness
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Oxytocin Secretion
研究概览
简要总结
Despite a range of treatments for posttraumatic stress disorder (PTSD), only a small proportion of patients reach full symptomatic remission. Recent developments in the field of neuroscience have been providing compelling evidence to suggest that neurobiological determinants might influence not only the emergence of PTSD, but also its resistance to treatment. Immune-inflammation regulatory processes were found to be active during recovery from PTSD, potentially through interactive relationship with the oxytocin secretion system. This innovative longitudinal study aims to examine the role of inflammatory biomarkers and their interactive effect with the oxytocin (OT) system on the development of PTSD and on treatment response among patients with PTSD symptoms undergoing psychotherapy treatment. Patients (N = 100) suffering from trauma-related distress will be recruited from the trauma clinic in Shalvata Mental Health Center. Participants will be followed for 12 weeks of once-a-week psychotherapy sessions. They will be measured for endogenous OT level and cytokines levels in saliva before and after sessions 1, 6, and 12, and will complete psychotherapy outcome self-report questionnaires following each of these sessions.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Minimum score of 33 on the PTSD symptoms questionnaire (PCL-5).
- •Anticipated 12-24 psychotherapy sessions.
排除标准
- •Psychotic episode.
- •Female patients: pregnancy or breastfeeding (according to self-report).
结局指标
主要结局
Oxytocin Secretion
时间窗: 12-16 weeks, depending on treatment duration
Endogenous oxytocin level in saliva
Inflammatory Response: IL-6
时间窗: 12-16 weeks, depending on treatment duration
inflammatory biomarker IL-6 assessed in saliva
General anxiety symptoms
时间窗: 12-16 weeks, depending on treatment duration
Generalized anxiety disorder (GAD-7): Self-report questionnaire consisting of 7 items ranging from 0-3. High scores indicate worst outcome.
Depression severity
时间窗: 12-16 weeks, depending on treatment duration
Patient health questionnaire (PHQ-9): Self-report questionnaire consisting of 9 items ranging from 0-3. High scores indicate worst outcome.
Inflammatory Response: TNF-α
时间窗: 12-16 weeks, depending on treatment duration
inflammatory biomarker TNF-α assessed in saliva
Posttraumatic stress disorder symptoms
时间窗: 12-16 weeks, depending on treatment duration
PTSD checklist for DSM-5 (PCL-5): Self-report questionnaire consisting of 20 items ranging from 0-4. High scores indicate worst outcome.
Inflammatory Response: IL-1β
时间窗: 12-16 weeks, depending on treatment duration
inflammatory biomarker IL-1β assessed in saliva
次要结局
- Psychological resilience(12-16 weeks, depending on treatment duration)
- Working Alliance(12-16 weeks, depending on treatment duration)
研究者
Yuval Bloch
Professor
Shalvata Mental Health Center
