Cognitive-Behavioural Therapy as a Preventive Treatment for Post Traumatic Stress Disorder
Cognitive-Behavioural Therapy as a Preventive Treatment for Post Traumatic Stress Disorder: An Randomized Controlled Trial in the Acute Trauma Care
연구 개요
상세 설명
This study investigates if prolonged exposure is an effective treatment in reducing PTSD symptoms people who have recently experienced trauma. The study will also investigate predictive markers of PTSD, moderators of successful treatment and health economic aspects of the intervention.
Participants will first undergo an evaluation session that will include an interview (Immediate Stress Reaction Checklist) and questionnaires. Participants will subsequently be randomly assigned to receive either modified prolonged exposure therapy or attention control, starting the assigned intervention immediately. Participants in each arm will receive three weekly treatment sessions. Treatment will involve psychoeducation about common reactions to trauma, imaginal exposure (revisiting memories of a recent trauma out loud with a therapist and audio-recording these for review at home), exposure in vivo and breathing retraining. All participants will undergo assessments 2, 6 (primary endpoint) and 12 months after the intervention by blinded assessors. Patients unable to come to the clinic for follow-up assessments will be interviewed via telephone or skype. Source data will be quality monitored by an independent party (Karolinska trial alliance) according to the Helsinki Declaration.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Stockholm, 스웨덴, 17177
- Karolinska Institutet
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Presenting to the emergency department at the Karolinska University hospital Solna in the past 72 hours before the intervention
- Meets diagnostic criterion A for post-traumatic stress disorder in the fifth version of Diagnostic and Statistical Manual of Mental Disorders, DSM-5
Exclusion Criteria:
- Do not want to participate in the study
- Ongoing intoxication (e.g. severe alcohol intoxication)
- Other serious psychiatric comorbidity that demands attention (e.g. manic episode, acute suicidal ideation)
- Not oriented
- Not having a memory ot the tramatic event
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Modified prolonged exposure therapy
Participants will receive three sessions of modified prolonged exposure therapy.
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Participants will receive three sessions of modified prolonged exposure therapy.
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위약 비교기: Attention control
Participants will receive three sessions of supportive counselling and psychoeducation
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Participants will receive three sessions of supportive counselling and psychoeducation
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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CLINICIAN-ADMINISTERED PTSD SCALE for Diagnostic and Statistical Manual of Mental Disorders-5 (CAPS)
기간: Change 2-, 6- (primary endpoint) and 12 months after intervention
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Clinical interview that gives a continuous measure of PTSD severity and dichotomous diagnosis of PTSD
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Change 2-, 6- (primary endpoint) and 12 months after intervention
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5)
기간: Change 2-, 6- (primary endpoint) and 12 months after intervention
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Self-report questionnaire for the assessment of PTSD severity
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Change 2-, 6- (primary endpoint) and 12 months after intervention
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Montgomery Åsberg Depression Rating Scale - Self-report (MADRS-S)
기간: Change from baseline to 2, 6 (primary endpoint) and 12 months after intervention
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Self-report questionnaire for the assessment of severity of depression
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Change from baseline to 2, 6 (primary endpoint) and 12 months after intervention
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Euroqol (EQ-5D)
기간: Measured 6 months after intervention
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Measure of general health and quality of life
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Measured 6 months after intervention
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WHO Disability Assessment Schedule (WHODAS)
기간: Change 2-, 6- (primary endpoint) and 12 months after intervention
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Measure of general health and function
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Change 2-, 6- (primary endpoint) and 12 months after intervention
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Adverse events
기간: Change 2-, 6- (primary endpoint) and 12 months after intervention
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Measure of number adverse events
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Change 2-, 6- (primary endpoint) and 12 months after intervention
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Subjective unit of distress scale (SUD)
기간: Change at week 1, week 2 and week 3
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Ratings of distress
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Change at week 1, week 2 and week 3
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Intrusion diary
기간: Change at week 1, week 2 and week 3
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A self-report diary on number of intrusions
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Change at week 1, week 2 and week 3
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Insomnia Severity Index (ISI)
기간: Change 2-, 6- (primary endpoint) and 12 months after intervention
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Self-report questionnaire regarding insomnia
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Change 2-, 6- (primary endpoint) and 12 months after intervention
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Multidimensional Scale of Perceived Social Support (MSPSS)
기간: Change 2-, 6- (primary endpoint) and 12 months after intervention
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A measure to assess for social support
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Change 2-, 6- (primary endpoint) and 12 months after intervention
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Trimbos Institute of costs in psychiatry (TIC-P)
기간: Measured at 6 (primary endpoint) months after the intervention
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Self-report measure on societal costs
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Measured at 6 (primary endpoint) months after the intervention
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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
- EPN 2015/1820-31
약물 및 장치 정보, 연구 문서
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미국 FDA 규제 기기 제품 연구
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