Group Compassion Focused Therapy for Posttraumatic Stress Disorder
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Clinical Administered Posttraumatic Stress 5
研究概览
简要总结
The purpose of this study is to determine the efficacy of a 8-week program of Compassion Focused Therapy in Group comparing to Supportive Cognitive Behavioral Therapy in Group for patients with Posttraumatic Stress Disorder.
详细描述
This study will be a randomized clinical trial with two parallel groups, with two models of treatment: Group 1 - Control Group - will receive CBT Supportive Group (CBT-SG) and Group 2 - Experimental Group - will receive Compassion Focused Therapy (CFT-G). Will be attended in total, the maximum of 80 patients, with 40 patients in each arm (CBT-SG versus CFT-G). Both groups will be formed by at least eight patients and a maximum of twelve patients who receive eight weekly sessions with an hour and a half each session, and the total duration of treatment will be eight weeks. The groups will be closed, that is, after the start will not be permitted to input any more participants. The experimental group (CFT-G) will be structured and the control group (CBT-SG) will be unstructured, and free format.
All patients will be assessed through self-report scales, within three distinct phases: Assessment I - Initial (before therapy); Assessment II - Final (after therapy); Assessment III - Follow-up (after 3 months of therapy ending).
All groups will be led by a principal therapist and co-therapist. All sessions will be recorded for later evaluation of the researcher responsible for the research.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Clinical Administered PTSD Scale 5 Monthly version Criteria A and >30 points
排除标准
- •Suicidal patients and/or severe automutilation behavior and/or psychotic symptoms and/or lack of event memory.
结局指标
主要结局
Clinical Administered Posttraumatic Stress 5
时间窗: up to 8 weeks
40% decrease
次要结局
- Beck Hopelessness Scale(up to 8 weeks)
- Davidson Trauma Scale(up to 8 weeks)
- Beck Depression Inventory(up to 8 weeks)
- Beck Anxiety Inventory(up to 8 weeks)
- Self Compassion Scale(up to 8 weeks)
- Other as a Shame Scale(up to 8 weeks)
- Functions of Self Critical Scale(up to 8 weeks)
- Connor Davidson Resilience(up to 8 weeks)
- Outcome Questionnaire 45(up to 8 weeks)
研究者
Francisco Lotufo Neto
PhD
University of Sao Paulo General Hospital