- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03154931
Efficacy of Compassion Focused Therapy in Group for Posttraumatic Stress Disorder (GCFT-PTSD)
Group Compassion Focused Therapy for Posttraumatic Stress Disorder
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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SP
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Sao Paulo, SP, 브라질, 05403-903
- AMBAN - Anxiety Program at IPQ-HCFMUSP
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Clinical Administered PTSD Scale 5 Monthly version Criteria A and >30 points
Exclusion Criteria:
- Suicidal patients and/or severe automutilation behavior and/or psychotic symptoms and/or lack of event memory.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: CBT-SG
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.
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To support the group.
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실험적: CFT-G
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.
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Teach compassionate skills.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Clinical Administered Posttraumatic Stress 5
기간: up to 8 weeks
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40% decrease
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up to 8 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Davidson Trauma Scale
기간: up to 8 weeks
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40% decrease
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up to 8 weeks
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Beck Depression Inventory
기간: up to 8 weeks
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final rating <20.
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up to 8 weeks
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Beck Anxiety Inventory
기간: up to 8 weeks
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final rating <19.
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up to 8 weeks
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Beck Hopelessness Scale
기간: up to 8 weeks
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final rating <9.
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up to 8 weeks
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Self Compassion Scale
기간: up to 8 weeks
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50% increase
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up to 8 weeks
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Other as a Shame Scale
기간: up to 8 weeks
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50% decrease
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up to 8 weeks
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Functions of Self Critical Scale
기간: up to 8 weeks
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50% decrease
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up to 8 weeks
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Connor Davidson Resilience
기간: up to 8 weeks
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50% increase
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up to 8 weeks
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Outcome Questionnaire 45
기간: up to 8 weeks
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50% decrease
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up to 8 weeks
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공동 작업자 및 조사자
수사관
- 연구 책임자: Francisco Lotufo Neto, PhD, University of Sao Paulo General Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Group CFT treatment for PTSD
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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