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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
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Stockholm、スウェーデン、17177
- Karolinska Institutet
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
|
プラセボコンパレーター：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
CLINICIAN-ADMINISTERED PTSD SCALE for Diagnostic and Statistical Manual of Mental Disorders-5 (CAPS)
時間枠：Change 2-, 6- (primary endpoint) and 12 months after intervention
|
Clinical interview that gives a continuous measure of PTSD severity and dichotomous diagnosis of PTSD
|
Change 2-, 6- (primary endpoint) and 12 months after intervention
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5)
時間枠：Change 2-, 6- (primary endpoint) and 12 months after intervention
|
Self-report questionnaire for the assessment of PTSD severity
|
Change 2-, 6- (primary endpoint) and 12 months after intervention
|
|
Montgomery Åsberg Depression Rating Scale - Self-report (MADRS-S)
時間枠：Change from baseline to 2, 6 (primary endpoint) and 12 months after intervention
|
Self-report questionnaire for the assessment of severity of depression
|
Change from baseline to 2, 6 (primary endpoint) and 12 months after intervention
|
|
Euroqol (EQ-5D)
時間枠：Measured 6 months after intervention
|
Measure of general health and quality of life
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Measured 6 months after intervention
|
|
WHO Disability Assessment Schedule (WHODAS)
時間枠：Change 2-, 6- (primary endpoint) and 12 months after intervention
|
Measure of general health and function
|
Change 2-, 6- (primary endpoint) and 12 months after intervention
|
|
Adverse events
時間枠：Change 2-, 6- (primary endpoint) and 12 months after intervention
|
Measure of number adverse events
|
Change 2-, 6- (primary endpoint) and 12 months after intervention
|
|
Subjective unit of distress scale (SUD)
時間枠：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
時間枠：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
|
|
Insomnia Severity Index (ISI)
時間枠：Change 2-, 6- (primary endpoint) and 12 months after intervention
|
Self-report questionnaire regarding insomnia
|
Change 2-, 6- (primary endpoint) and 12 months after intervention
|
|
Multidimensional Scale of Perceived Social Support (MSPSS)
時間枠：Change 2-, 6- (primary endpoint) and 12 months after intervention
|
A measure to assess for social support
|
Change 2-, 6- (primary endpoint) and 12 months after intervention
|
|
Trimbos Institute of costs in psychiatry (TIC-P)
時間枠：Measured at 6 (primary endpoint) months after the intervention
|
Self-report measure on societal costs
|
Measured at 6 (primary endpoint) months after the intervention
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- EPN 2015/1820-31
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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