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临床试验/NCT03154931
NCT03154931Unknown不适用

Group Compassion Focused Therapy for Posttraumatic Stress Disorder

University of Sao Paulo General Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2015年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
80
试验地点
1
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.

研究组 & 干预措施

CBT-SG

Active Comparator

This CBT-Supportive group will focus on the interaction here-and-now, realizing that the group acts as a secure place, driven by interactions among its participants and therapist and co-therapist. The main objective is to welcome and support the participation of all patients and stimulate the group's initiatives, encouraging interpersonal interactions and mutual aid. There will be no specific therapeutic intervention in relation to any PTSD related content.

干预措施: CBT-SG (Other)

CFT-G

Experimental

This CFT-group will focus on activities using specific therapeutic strategies, to learn and training compassionate skills - psychoeducation and exercises developed for use in session and at home.They will learn What is compassion and shame? Steps to the training of compassion and how Building a compassionate image. Will use Thoughts Daily Record - self critical and self compassionate. Explanation of Formulation of Strategy Threats and Security, The Three Emotional regulation systems and PTSD formulation - based on shame and guilt. They will learn how to incorporate these skills to everyday situations. At the end, will write an Autobiography writing about this experience and share with the group.

干预措施: CFT-G (Other)

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

  • Functions of Self Critical Scale(up to 8 weeks)
  • Connor Davidson Resilience(up to 8 weeks)
  • Outcome Questionnaire 45(up to 8 weeks)
  • Self Compassion 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)
  • Beck Hopelessness Scale(up to 8 weeks)
  • Other as a Shame Scale(up to 8 weeks)

研究者

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

Francisco Lotufo Neto

PhD

University of Sao Paulo General Hospital

研究点 (1)

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