A Clinical Study Evaluating the Effects of a SEE FAR CBT Intervention on Psychological Outcomes in Adults With Posttraumatic Stress Disorder.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in PTSD symptoms
研究概览
简要总结
This single-arm clinical intervention study evaluates a 12-session SEE FAR CBT intervention for adults aged 18 years and older with posttraumatic stress disorder (PTSD). SEE FAR CBT is a trauma-focused cognitive-behavioral treatment approach. Participants will complete self-report psychological questionnaires at three time points: baseline, after completion of the intervention, and at a 3-month follow-up. The study aims to examine changes in PTSD symptoms and related psychological outcomes over the course of treatment and follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must meet all of the following criteria:
- •Age 18 years or older
- •PTSD symptoms, defined as a PCL-5 score of 30 or above
- •Able to provide informed consent
- •Willing and able to participate in 12 weekly individual therapy sessions and complete study questionnaires at baseline, post-intervention, and 3-month follow-up
排除标准
- •Participants will be excluded if they meet any of the following criteria:
- •Pregnancy at the time of enrollment, due to the potential influence of pregnancy and childbirth during the treatment or follow-up period on psychological outcomes.
- •Currently receiving psychotherapy of any type that began less than 3 months prior to enrolment.
- •Initiation of psychiatric medication less than 3 months prior to enrolment.
结局指标
主要结局
Change in PTSD symptoms
时间窗: Baseline, 12-16 weeks after baseline, and 3 months after completion of the intervention
PTSD Checklist for DSM-5 (PCL-5). PTSD symptoms will be assessed using the PCL-5. Total scores range from 0 to 80, with higher scores indicating greater PTSD symptom severity. Change in PCL-5 total score will be examined from baseline to post-intervention, from baseline to 3-month follow-up, and from post-intervention to 3-month follow-up.
Change in anxiety symptoms
时间窗: Baseline, 12-16 weeks after baseline, and 3 months after completion of the intervention
Generalized Anxiety Disorder-7 (GAD-7). Anxiety symptoms will be assessed using the GAD-7. Total scores range from 0 to 21, with higher scores indicating greater anxiety symptom severity. Change in GAD-7 total score will be examined from baseline to post-intervention, from baseline to 3-month follow-up, and from post-intervention to 3-month follow-up.
次要结局
- Change in depressive symptoms(Baseline, 12-16 weeks after baseline, and 3 months after completion of the intervention)
- Change in perceived stress(Baseline, 12-16 weeks after baseline, and 3 months after completion of the intervention)
- Change in resilience(Baseline, 12-16 weeks after baseline, and 3 months after completion of the intervention)
- Change in somatic symptoms(Baseline, 12-16 weeks after baseline, and 3 months after completion of the intervention)
- Change in trauma-related use of imagination and coping(Baseline, 12-16 weeks after baseline, and 3 months after completion of the intervention)