- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05523453
외상 후 건강에 대한 긍정적인 기억에 대한 치료 초점의 효과 조사
외상 후 스트레스 장애에 대한 새로운 치료법의 검토 및 개선: 긍정적 기억 기법 처리(PPMT)
외상 후 스트레스 장애(PTSD)는 건강에 치명적인 영향을 미칩니다. 증거 기반 PTSD 개입은 개인과 사회의 건강에 대한 PTSD의 상당한 부담을 해결합니다. 그러나 이러한 개입을 받는 여러 개인이 탈락하고 모든 개인이 PTSD 증상의 개선을 경험하는 것은 아닙니다. 더욱이, 이러한 현재의 PTSD 개입은 주로 트라우마 기억을 표적으로 합니다. 특히, 증가하는 증거는 PTSD 증상이 긍정적인 기억의 인코딩 및 검색의 어려움과 관련이 있음을 시사합니다.
따라서 제안된 연구는 긍정적인 기억을 설명하고 자세히 설명하는 데 중점을 둔 새로운 PTSD 기술인 PPMT(Positive Memories Technique)의 효과와 대상을 조사할 것입니다. 방법론적으로 70명의 개인이 이 연구를 위해 PPMT 대 지원 상담(SC)에 무작위로 배정됩니다.
제안된 연구의 목적은 다음을 포함합니다. (2) PPMT 효과의 기본 메커니즘을 조사합니다. 및 (3) 정제 PPMT. PPMT 팔이 PTSD 중증도 및 sAA/코르티솔 비율의 더 큰 감소를 보고할 것이라는 가설이 있습니다. 또한 PPMT 관련 개선된 정동이 연구 부문(PPMT 대 SC)과 PTSD 중증도의 변화 사이의 연관성을 매개할 것이라는 가설이 있습니다. 마지막으로 PPMT의 실행 가능성, 형식 및 내용에 대해 연구 참가자로부터 PPMT를 개선하기 위한 피드백을 얻을 것입니다.
제안된 연구는 PTSD 개입에서 긍정적인 기억을 표적으로 삼는 것의 잠재적 중요성에 대한 예비 증거를 제공할 수 있습니다.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Texas
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Denton, Texas, 미국, 76203
- University of North Texas
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
설명
포함 기준:
- 18-65세
- 정보에 입각한 동의를 제공할 의향/능력
- 지난달 DSM-5 외상 후 스트레스 장애(PTSD) 진단
- 영어 실무 지식
제외 기준:
- 적극적인 자살 의도 또는 시도
- 활성 정신병
- 현재 정신과 치료를 받고 있음(지난 3개월)
- 정신과 약물의 용량 변화(지난 3개월)
- 현재 임신 중
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: PPMT(긍정적 기억 기법 처리)
참가자는 PPMT 치료 매뉴얼에 설명된 치료 절차에 따라 PTSD에 대한 60분 PPMT(Processing of Positive Memories Technique) 세션을 5번 받습니다.
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PPMT는 긍정적인 기억을 식별하고 처리하는 데 중점을 둔 5개의 세션으로 구성됩니다.
세션 1-5에서 참가자는 하나의 긍정적인 기억에 대해 자세히 설명하고 긍정적인 기억을 처리하여 긍정적인 가치, 영향, 강점 및 생각을 이끌어냅니다.
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활성 비교기: 지원 상담(SC)
참가자는 60분 동안 지원 상담(SC) 세션을 5번 받습니다.
SC에는 일일 모니터링 일지에 대한 토론과 현재 문제 및 우려 사항에 대한 탐색이 포함됩니다.
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SC는 매주 실시되는 5회기의 능동적이고 비특이적인 치료로, 일일 모니터링 일지에 대한 토론과 현재 문제 및 우려 사항에 대한 탐색이 포함됩니다.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Scores
기간: Baseline
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The 20-item self-report PTSD Checklist for DSM-5 (PCL-5) assessed past-week posttraumatic stress disorder (PTSD) severity.
Response options ranged from 0 (not at all) to 4 (extremely), with the possible range being from 0 to 80. Higher scores indicate more PTSD symptom severity.
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Baseline
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Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Scores
기간: Week 1 post-baseline during therapy session
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The 20-item self-report PTSD Checklist for DSM-5 (PCL-5) assessed past-week posttraumatic stress disorder (PTSD) severity.
Response options ranged from 0 (not at all) to 4 (extremely), with the possible range being from 0 to 80. Higher scores indicate more PTSD symptom severity.
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Week 1 post-baseline during therapy session
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Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Scores
기간: Week 2 post-baseline during therapy session
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The 20-item self-report PTSD Checklist for DSM-5 (PCL-5) assessed past-week posttraumatic stress disorder (PTSD) severity.
Response options ranged from 0 (not at all) to 4 (extremely), with the possible range being from 0 to 80. Higher scores indicate more PTSD symptom severity.
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Week 2 post-baseline during therapy session
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Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Scores
기간: Week 3 post-baseline during therapy session
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The 20-item self-report PTSD Checklist for DSM-5 (PCL-5) assessed past-week posttraumatic stress disorder (PTSD) severity.
Response options ranged from 0 (not at all) to 4 (extremely), with the possible range being from 0 to 80. Higher scores indicate more PTSD symptom severity.
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Week 3 post-baseline during therapy session
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Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Scores
기간: Week 4 post-baseline during therapy session
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The 20-item self-report PTSD Checklist for DSM-5 (PCL-5) assessed past-week posttraumatic stress disorder (PTSD) severity.
Response options ranged from 0 (not at all) to 4 (extremely), with the possible range being from 0 to 80. Higher scores indicate more PTSD symptom severity.
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Week 4 post-baseline during therapy session
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Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Scores
기간: Week 5 post-baseline during therapy session
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The 20-item self-report PTSD Checklist for DSM-5 (PCL-5) assessed past-week posttraumatic stress disorder (PTSD) severity.
Response options ranged from 0 (not at all) to 4 (extremely), with the possible range being from 0 to 80. Higher scores indicate more PTSD symptom severity.
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Week 5 post-baseline during therapy session
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Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Scores
기간: 1 week after the last therapy session, at week 6 post-baseline
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The 20-item self-report PTSD Checklist for DSM-5 (PCL-5) assessed past-week posttraumatic stress disorder (PTSD) severity.
Response options ranged from 0 (not at all) to 4 (extremely), with the possible range being from 0 to 80. Higher scores indicate more PTSD symptom severity.
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1 week after the last therapy session, at week 6 post-baseline
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Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Scores
기간: 3-months posttreatment completion, at week 18 post-baseline
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The 20-item self-report PTSD Checklist for DSM-5 (PCL-5) assessed past-week posttraumatic stress disorder (PTSD) severity.
Response options ranged from 0 (not at all) to 4 (extremely), with the possible range being from 0 to 80. Higher scores indicate more PTSD symptom severity.
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3-months posttreatment completion, at week 18 post-baseline
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Awakening Salivary Alpha Amylase to Cortisol Ratio
기간: 3 times each day for 2 consecutive days prior to first therapy session
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Via a passive drool procedure, participants provided 3 whole saliva samples each day for 2 consecutive days both prior to PPMT/SC: (1) immediately upon awakening, (2) 30 minutes post-awakening, and (3) 60 minutes post-awakening.
For each marker, for each day, area under the curve with respect to ground (AUCg) was calculated.
The two-day average AUCg of sAA was then divided by the two-day average AUCg of cortisol to create the ratio variable.
Higher sAA/cortisol ratio indicates greater stress system dysregulation and sympathetic nervous system dominance.
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3 times each day for 2 consecutive days prior to first therapy session
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Awakening Salivary Alpha Amylase to Cortisol Ratio
기간: 3 times each day for 2 consecutive days after the last therapy session
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Via a passive drool procedure, participants provided 3 whole saliva samples each day for 2 consecutive days one week following PPMT/SC: (1) immediately upon awakening, (2) 30 minutes post-awakening, and (3) 60 minutes post-awakening.
For each marker, for each day, area under the curve with respect to ground (AUCg) was calculated.
The two-day average AUCg of sAA was then divided by the two-day average AUCg of cortisol to create the ratio variable.
Higher sAA/cortisol ratio indicates greater stress system dysregulation and sympathetic nervous system dominance.
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3 times each day for 2 consecutive days after the last therapy session
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Positive and Negative Affect Schedule
기간: Baseline
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The 20-item Positive and Negative Affect Schedule (PANAS) examined past-week positive and negative affect levels. There were 10 items for each of the PANAS-Positive and PANAS-Negative subscales, which measure past-week positive and negative affect respectively. Response options ranged from 1 (not at all/very slightly) to 5 (extremely), with the possible range being from 10 to 50 for each subscale. Higher scores mean more self-reported positive affect and negative affect for the PANAS-Positive and PANAS-Negative subscales respectively. |
Baseline
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Positive and Negative Affect Schedule
기간: Week 1 post-baseline during therapy session
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The 20-item Positive and Negative Affect Schedule (PANAS) examined past-week positive and negative affect levels. There were 10 items for each of the PANAS-Positive and PANAS-Negative subscales, which measure past-week positive and negative affect respectively. Response options ranged from 1 (not at all/very slightly) to 5 (extremely), with the possible range being from 10 to 50 for each subscale. Higher scores mean more self-reported positive affect and negative affect for the PANAS-Positive and PANAS-Negative subscales respectively. |
Week 1 post-baseline during therapy session
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Positive and Negative Affect Schedule
기간: Week 2 post-baseline during therapy session
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The 20-item Positive and Negative Affect Schedule (PANAS) examined past-week positive and negative affect levels. There were 10 items for each of the PANAS-Positive and PANAS-Negative subscales, which measure past-week positive and negative affect respectively. Response options ranged from 1 (not at all/very slightly) to 5 (extremely), with the possible range being from 10 to 50 for each subscale. Higher scores mean more self-reported positive affect and negative affect for the PANAS-Positive and PANAS-Negative subscales respectively. |
Week 2 post-baseline during therapy session
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Positive and Negative Affect Schedule
기간: Week 3 post-baseline during therapy session
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The 20-item Positive and Negative Affect Schedule (PANAS) examined past-week positive and negative affect levels. There were 10 items for each of the PANAS-Positive and PANAS-Negative subscales, which measure past-week positive and negative affect respectively. Response options ranged from 1 (not at all/very slightly) to 5 (extremely), with the possible range being from 10 to 50 for each subscale. Higher scores mean more self-reported positive affect and negative affect for the PANAS-Positive and PANAS-Negative subscales respectively. |
Week 3 post-baseline during therapy session
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Positive and Negative Affect Schedule
기간: Week 4 post-baseline during therapy session
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The 20-item Positive and Negative Affect Schedule (PANAS) examined past-week positive and negative affect levels. There were 10 items for each of the PANAS-Positive and PANAS-Negative subscales, which measure past-week positive and negative affect respectively. Response options ranged from 1 (not at all/very slightly) to 5 (extremely), with the possible range being from 10 to 50 for each subscale. Higher scores mean more self-reported positive affect and negative affect for the PANAS-Positive and PANAS-Negative subscales respectively. |
Week 4 post-baseline during therapy session
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Positive and Negative Affect Schedule
기간: Week 5 post-baseline during therapy session
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The 20-item Positive and Negative Affect Schedule (PANAS) examined past-week positive and negative affect levels. There were 10 items for each of the PANAS-Positive and PANAS-Negative subscales, which measure past-week positive and negative affect respectively. Response options ranged from 1 (not at all/very slightly) to 5 (extremely), with the possible range being from 10 to 50 for each subscale. Higher scores mean more self-reported positive affect and negative affect for the PANAS-Positive and PANAS-Negative subscales respectively. |
Week 5 post-baseline during therapy session
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Positive and Negative Affect Schedule
기간: 1 week after the last therapy session, at week 6 post-baseline
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The 20-item Positive and Negative Affect Schedule (PANAS) examined past-week positive and negative affect levels. There were 10 items for each of the PANAS-Positive and PANAS-Negative subscales, which measure past-week positive and negative affect respectively. Response options ranged from 1 (not at all/very slightly) to 5 (extremely), with the possible range being from 10 to 50 for each subscale. Higher scores mean more self-reported positive affect and negative affect for the PANAS-Positive and PANAS-Negative subscales respectively. |
1 week after the last therapy session, at week 6 post-baseline
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Positive and Negative Affect Schedule
기간: 3-months posttreatment completion, at week 18 post-baseline
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The 20-item Positive and Negative Affect Schedule (PANAS) examined past-week positive and negative affect levels. There were 10 items for each of the PANAS-Positive and PANAS-Negative subscales, which measure past-week positive and negative affect respectively. Response options ranged from 1 (not at all/very slightly) to 5 (extremely), with the possible range being from 10 to 50 for each subscale. Higher scores mean more self-reported positive affect and negative affect for the PANAS-Positive and PANAS-Negative subscales respectively. |
3-months posttreatment completion, at week 18 post-baseline
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공동 작업자 및 조사자
수사관
- 수석 연구원: Ateka Contractor, PHD, University of North Texas Health Science Center
간행물 및 유용한 링크
일반 간행물
- Contractor AA, Blumenthal H, Rosenfield D, Shea MT, Taylor DJ, Fentem A, Vingren JL. Study protocol and rationale for a pilot randomized clinical trial comparing processing of positive memories technique with supportive counseling for PTSD. Contemp Clin Trials. 2024 Mar;138:107455. doi: 10.1016/j.cct.2024.107455. Epub 2024 Jan 20.
- Rodenbaugh MM, Almeida I, Solakoglu L, Jin L, Contractor AA. Client and therapist experiences with the Processing of Positive Memories Technique (PPMT) in a randomized controlled trial: insights for protocol refinement. Eur J Psychotraumatol. 2026 Dec;17(1):2692887. doi: 10.1080/20008066.2026.2692887. Epub 2026 Jul 29.
- Contractor AA, Rosenfield D, Almeida IM, Wang S, Taylor DJ, Weiss NH, Shea MT. Comparison of the processing of positive memories technique and supportive counseling for posttraumatic stress disorder: A randomized controlled trial. Behav Res Ther. 2026 Aug;203:105087. doi: 10.1016/j.brat.2026.105087. Epub 2026 May 19.
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
- R15MH129773-01A1 (미국 NIH 보조금/계약)
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
미국에서 제조되어 미국에서 수출되는 제품
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