- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07672613
EMDR Flash Group Protocol for Earthquake Survivors (FlashGP-EQ)
Preliminary Effects of an Early EMDR Flash Group Intervention on Traumatic Stress, Anxiety, and Depressive Symptoms Among Earthquake Survivors: A Pilot Randomized Controlled Trial
연구 개요
상세 설명
The Kahramanmaraş earthquakes of February 2023 affected millions of people and were associated with substantial psychological distress, including posttraumatic stress, anxiety, and depressive symptoms. Early psychological interventions may help reduce acute distress and improve posttraumatic outcomes following disaster exposure.
This pilot randomized controlled trial was conducted approximately one month after the earthquakes. Adults affected by the disaster were recruited online and randomized in a 1:1 ratio to either the EMDR Flash Group Protocol intervention or a waitlist control condition. The intervention was delivered online via Zoom by trained mental health professionals using a standardized protocol consisting of two group sessions.
The primary objective was to evaluate the preliminary effects of the EMDR Flash Group Protocol on posttraumatic stress symptoms. Secondary objectives were to evaluate changes in depression, anxiety, and stress symptoms. Outcomes were assessed using self-report measures at baseline and at 3-month follow-up.
This study was conducted as a pilot trial to evaluate the feasibility and preliminary effectiveness of the intervention following a large-scale natural disaster.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Istanbul
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Istanbul, Istanbul, 터키 (Türkiye)
- Istanbul Galata University
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age 18 years or older
- Present in the earthquake-affected region during the 2023 Kahramanmaraş earthquakes
- Directly experienced the earthquake or were affected through disaster-related exposure
- Ability to participate in online sessions
- Access to the necessary technological equipment and internet connection
- Ability to provide informed consent
Exclusion Criteria:
- Intellectual disability
- Current or past psychotic disorder (e.g., schizophrenia)
- Bipolar disorder
- History of severe head trauma
- Inability to participate in the online intervention format
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: EMDR Flash Group Protocol
Participants received the online EMDR Flash Group Protocol delivered by trained mental health professionals.
The intervention consisted of two group sessions lasting approximately 60 to 90 minutes and was conducted via Zoom approximately one month after the 2023 Kahramanmaraş earthquakes.
|
The EMDR Flash Group Protocol was delivered online via Zoom by trained mental health professionals.
The intervention consisted of two group sessions lasting approximately 60-90 minutes and was administered approximately one month after the 2023 Kahramanmaraş earthquakes.
|
|
간섭 없음: Waitlist Control
Participants assigned to the waitlist control group did not receive the EMDR Flash Group Protocol during the study period and completed the same assessment schedule as the intervention group.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in PTSD Symptoms (PCL-5 Total Score)
기간: Assessed at baseline (pre-intervention) and at 3-month follow-up.
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Change in posttraumatic stress symptom severity measured by the PTSD Checklist for DSM-5 (PCL-5) total score from baseline to 3-month follow-up.
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Assessed at baseline (pre-intervention) and at 3-month follow-up.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Depression Symptoms (DASS-21 Depression)
기간: Assessed at baseline (pre-intervention) and at 3-month follow-up.
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Change in depression symptom severity measured by the Depression Anxiety Stress Scale-21 (DASS-21) Depression subscale from baseline to 3-month follow-up.
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Assessed at baseline (pre-intervention) and at 3-month follow-up.
|
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Change in Anxiety Symptoms (DASS-21 Anxiety)
기간: Assessed at baseline (pre-intervention) and at 3-month follow-up.
|
Change in anxiety symptom severity measured by the DASS-21 Anxiety subscale from baseline to 3-month follow-up.
|
Assessed at baseline (pre-intervention) and at 3-month follow-up.
|
|
Change in Stress Symptoms (DASS-21 Stress)
기간: Assessed at baseline (pre-intervention) and at 3-month follow-up.
|
Change in depression symptom severity measured by the Depression Anxiety Stress Scale-21 (DASS-21) Depression subscale from baseline to 3-month follow-up.
|
Assessed at baseline (pre-intervention) and at 3-month follow-up.
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
- EMDRFLASHGP-2023-RCT
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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