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临床试验/NCT06348472
NCT06348472招募中不适用

The Predictive Role of Immune-inflammatory Biomarkers and Their Interaction With the Oxytocin System in Trauma-related Psychotherapy Responsiveness

Shalvata Mental Health Center1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年3月14日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yuval Bloch

Professor

Shalvata Mental Health Center

研究点 (1)

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