A Clinical Study Evaluating the Effects of a Brief SEE FAR CBT Intervention Compared With Dynamic Psychotherapy Treatment as Usual 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 clinical intervention study evaluates a newly developed Brief SEE FAR CBT protocol for adults aged 18 years and older with posttraumatic stress disorder (PTSD), compared with dynamic psychotherapy treatment as usual. Participants in the Brief SEE FAR CBT group will receive 6 focused sessions emphasizing intrusive PTSD symptoms and will then continue to complete the full 12-session SEE FAR CBT protocol. Participants in the control group will receive dynamic psychotherapy as treatment as usual. Psychological outcomes will be assessed using self-report questionnaires at four time points: baseline, after 6 sessions, after 12 sessions, and at a 3-month follow-up. The study aims to examine changes in PTSD symptoms, anxiety, depression, perceived stress, resilience, somatic symptoms, sleep quality, 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
- 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 —（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 30-60
- •Hebrew-speaking
- •Able to provide informed consent
- •Willing and able to participate in the assigned psychological intervention and complete study questionnaires at baseline, after 6 sessions, after 12 sessions, and at 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 enrollment
- •Initiation of psychiatric medication less than 3 months prior to enrollment
结局指标
主要结局
Change in PTSD symptoms
时间窗: Baseline, 6 weeks after baseline, 12 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 after 6 sessions, from baseline to after 12 sessions, from baseline to 3-month follow-up, from after 6 sessions to after 12 sessions, and from after 12 sessions to 3-month follow-up.
Change in anxiety symptoms
时间窗: Baseline, 6 weeks after baseline, 12 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 after 6 sessions, from baseline to after 12 sessions, from baseline to 3-month follow-up, from after 6 sessions to after 12 sessions, and from after 12 sessions to 3-month follow-up.
次要结局
- Change in depressive symptoms(Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention)
- Change in perceived stress(Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention)
- Change in resilience(Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention)
- Change in somatic symptoms(Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention)
- Change in trauma-related use of imagination and coping(Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention)
- Change in sleep quality(Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention)
- Change in PTSD-related functional impairment(Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention)