今日の臨床サポート

心的外傷後ストレス障害・急性ストレス障害

著者: 飛鳥井望 医療法人社団青山会青木病院/公益財団法人東京都医学総合研究所

監修: 上島国利 昭和大学

著者校正/監修レビュー済:2022/06/23
参考ガイドライン:
  1. 国際トラウマティック・ストレス学会:PTSDの予防・治療ガイドライン 第3版[1]
患者向け説明資料

概要・推奨   

  1. PTSDの有病率は国による違いはあるものの、男性よりも女性の有病率が高い。外傷(トラウマ)的出来事の種類により発症率は異なり、災害や事故に比べ、暴力犯罪やレイプなどの深刻な性被害では発症率が高まる。またPTSDでは、うつ病、不安障害、物質依存などを合併している割合が高い。
  1. トラウマ的出来事の体験者の多くは何らかの程度のストレス反応を生じるが、その多くは自然に回復し、PTSDとなるのは一部である。
  1. PTSDの危険因子となる心理社会的要因は、より大きな生命的危険の認知、社会的サポートの欠如、トラウマ体験時の感情反応(恐怖、孤立無援感、自責など)や解離反応、トラウマ体験後の生活ストレスである。
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薬剤監修について:
オーダー内の薬剤用量は日本医科大学付属病院 薬剤部 部長 伊勢雄也 以下、林太祐、渡邉裕次、井ノ口岳洋、梅田将光による疑義照会のプロセスを実施、疑義照会の対象については著者の方による再確認を実施しております。
※薬剤中分類、用法、同効薬、診療報酬は、エルゼビアが独自に作成した薬剤情報であり、 著者により作成された情報ではありません。
尚、用法は添付文書より、同効薬は、薬剤師監修のもとで作成しております。
※同効薬・小児・妊娠および授乳中の注意事項等は、海外の情報も掲載しており、日本の医療事情に適応しない場合があります。
※薬剤情報の(適外/適内/⽤量内/⽤量外/㊜)等の表記は、エルゼビアジャパン編集部によって記載日時にレセプトチェックソフトなどで確認し作成しております。ただし、これらの記載は、実際の保険適応の査定において保険適応及び保険適応外と判断されることを保証するものではありません。また、検査薬、輸液、血液製剤、全身麻酔薬、抗癌剤等の薬剤は保険適応の記載の一部を割愛させていただいています。
(詳細はこちらを参照)
著者のCOI(Conflicts of Interest)開示:
飛鳥井望 : 特に申告事項無し[2022年]
監修:上島国利 : 原稿料(大日本住友製薬)[2022年]

改訂のポイント:
  1. 2018年に発表された世界保健機関(WHO)の国際疾病分類第11版(ICD-11)による『心的外傷後ストレス症(PTSD)』ならびに『複雑性心的外傷後ストレス症(Complex PTSD)』についての解説を追加した。
  1. 海外の最新の治療ガイドラインからエビデンスに基づいた治療を紹介した。
  1. 自記式質問紙としてPTSDチェックリスト(PCL-5)を追加した。

病態・疫学・診察

疾患情報(疫学・病態)  
  1. 心的外傷後ストレス障害(症)(post-traumatic stress disorder、PTSD)および急性ストレス障害(acute stress disorder、ASD)とは、生命や身体に脅威を及ぼし、強い恐怖感や無力感を伴い、精神的衝撃を与える心的外傷(トラウマ)的出来事の後に生じる、特徴的なストレス症状群である。
  1. トラウマ的出来事には、災害、深刻な事故、暴力犯罪や性暴力被害、虐待やドメスティック・バイオレンス、拉致監禁、テロ、戦闘などが挙げられる。
  1. 自分自身が直接の被害者とならなくても、凄惨な光景を目撃したり、あるいは家族・知人が被害を受けたことで強い精神的衝撃を受けることも原因となる。災害救援者の惨事ストレス体験も含まれる。
  1. ただし、失職、失恋、破産などの個人的挫折体験はPTSDの原因とはみなさない。
  1. 米国精神医学会診断基準(DSM-5)では、トラウマ的出来事に曝露後3日以上1カ月以内の症状に対してはASDと診断し、1カ月以上持続する場合にはPTSDと診断する。したがって出来事から1カ月後の時点を境に診断が変更されることになる。
  1. 世界保健機関(WHO)の国際疾病分類第11版(ICD-11)では、トラウマ的出来事から間もない時期の急性ストレス反応は脅威がなくなれば数日以内に回復する一過性可逆性の反応として精神疾患カテゴリーからは除外された。ICD-11では基準を満たすトラウマ症状が数週間以上持続していれば1か月以内であってもPTSDと診断される。
  1. ICD-11では、虐待やドメスティック・バイオレンス、政治的難民など長期に繰り返され逃れられないトラウマ後に見られやすい症状群として複雑性PTSDの診断を定義づけている。
  1. DSM-5のPTSDは以下の4症状クラスターからなる[2]
  1. 1.侵入症状(フラッシュバックや悪夢など)
  1. 2.回避症状(出来事を想起することの回避、想起刺激となる事物・人物・状況の回避)
  1. 3.認知と気分の陰性の変化(否定的信念や歪んだ認識、興味や関心の低下、陽性感情の消失など)
  1. 4.覚醒度と反応性の著しい変化(怒りの爆発、過度の警戒心、過敏反応、集中困難、睡眠障害など)
  1. PTSDのサブタイプとして解離症状(離人感や現実感喪失)を伴う場合と、子ども(6歳以下)の場合の基準がもうけられている。
  1. ASDは侵入症状、陰性気分、解離症状、回避症状、覚醒症状の5領域14症状のうち9症状以上が存在すれば該当する。
  1. ICD-11のPTSDは以下の3症状クラスターからなる[3]
  1. 1.再体験症状(解離性フラッシュバックや悪夢)
  1. 2.回避症状(出来事を想起することの回避、想起刺激となる事物・人物・状況の回避)
  1. 3.脅威の感覚(過度の警戒心や過剰な驚愕反応)
  1. ICD-11の複雑性PTSDは上記の3症状クラスターに「自己組織化の障害」として以下の3症状クラスターが加わり6症状クラスターからなる[4]
  1. 4.感情制御の困難(感情不安定ないしは感情の麻痺や解離)
  1. 5.否定的自己概念(自己の無価値感や敗北感)
  1. 6.対人関係障害(対人関係の忌避、親密感の困難)
PTSDは4種類の症状が揃った病態

PTSDの4症状クラスターの内容
参考文献:飛鳥井望.心的外傷後ストレス症.In 講座 精神疾患の臨床3 不安または恐怖関連症群・強迫症・ストレス関連症群・パーソナリティ症(三村将編).中山書店, 2021、pp243-253

出典

img1:  著者提供
 
 
  1. DSM-5もICD-11も症状による顕著な苦痛感ないしは生活上、仕事上の支障を来していることがPTSDの診断要件となる。
  1. 米国の調査では、PTSDは女性の有病率が男性の約2倍と高く、災害や事故に比べ、深刻な性犯罪や暴力犯罪の被害のほうが発症率は高い。またPTSDの約1/3が長期に慢性化していた[5]
 
  1. 疫学レジリエンス
  1. 外傷的出来事の体験者の多くは何らかの程度のストレス反応を生じるが、その多くは自然に回復し、PTSDとなるのは一部である。
  1. 心的外傷性ストレスの影響をほとんどないしわずかにしか受けない耐久性をレジスタンス、ストレスの影響を受けても速やかに回復する復元力をレジリエンス、さらに時間が経過してから回復する場合をリカバリーと定義すると、ニューヨークWTCテロ事件(2002年)後に周辺住民1,267人を縦断調査(6-42カ月)した報告では、レジスタンス型53%、レジリエンス型10%、リカバリー型9%、遅発型(再燃含む)14%、遷延型13%であった。したがってレジスタンス型、レジリエンス型、リカバリー型を合わせれば約7割と大多数を占めた[6]。トラウマ的出来事後にはほとんどの者がなんらかのストレス反応を経験するが、大半の者は自然経過の中で回復することが期待できる。
  1. 疫学:有病率
  1. PTSDの有病率は国による違いはあるものの、男性よりも女性の有病率が高い。またトラウマ的出来事の種類により発症率は異なる傾向にある。
  1. WHO世界保健調査(2017)の結果では、わが国の一般人口中の生涯有病率は1.2%、トラウマ体験者中の生涯有病率は2.1%であった。トラウマ体験者中の生涯有病率はオーストラリア(9.6%)や米国(8.3%)では高いが、ドイツ(2.5%)やイスラエル(2.1%)はわが国に近いレベルである[7]
  1. わが国での救命救急センターに入院した重症交通外傷患者100例の調査結果では、多くの者が何らかの程度のストレス反応を生じていたが、ASDの発症率は9.0%、6カ月後のPTSD発症率は8.5%であった[8]。また阪神淡路大震災により全壊・全焼被災者のPTSD有病率は9.6%であった[9]。したがって大災害や重度事故においてもPTSDの発症率は限られたものである。
  1. 災害や事故に比べ、暴力や性暴力の被害ではPTSD発症率が高まる[5][10]。レイプなどの深刻な性被害はもっとも発症率が高く、男女にかかわらず半数近くがPTSDを発症する[5] <図表>
  1. PTSDにはうつ病、不安障害、物質依存など他の精神障害が高い割合で合併する[5][10][11]。米国の調査ではPTSDの約半数にうつ病が合併していた。
 
トラウマ的出来事の種類によるPTSDの生涯有病率

トラウマ的出来事の種類によりPTSDの発症率は異なる。

出典

img1:  Prevalence, severity, and comorbidity of 12-month DSM-IV disorders in the National Comorbidity Survey Replication.
 
 Arch Gen Psychiatry. 2005 Jun;62(6):617-・・・
 
  1. 危険因子
  1. PTSDの危険因子となる心理社会的要因は、より大きな生命的危険の認知、社会的サポートの欠如、トラウマ体験時の感情反応(恐怖、孤立無援感、自責など)や解離反応、トラウマ体験後の生活ストレスである。
  1. Brewinら[12]による77報告のメタアナリシスでは、基本属性要因として年齢、性別、社会経済状況、教育歴、人種を含み、他の要因として、精神疾患の家族歴、知性、児童期の不良な環境とトラウマ、他のトラウマ、トラウマ体験の重篤度、社会的サポート、トラウマ体験後の生活ストレスなどが含まれた。その結果、PTSDの発症リスク要因として推定効果量(effect size)が最も大きかったのは、社会的サポートの欠如であった。
  1. Ozerら[13]による68報告のメタアナリシスの結果においても、個人的特性や生活歴に関する要因の推定効果量はおしなべて小さい。具体的には、過去の精神的問題、過去のトラウマ体験、家族の精神疾患歴、性別、年齢、教育歴、社会経済的状況、IQ、人種といった要因である。一方、推定効果量が相対的に大きかったのは、よりトラウマ体験に近接した要因であり、具体的には、生命的危険の認知、社会的サポートの認知、トラウマ体験時の感情反応(恐怖、孤立無援感、自責など)や解離反応、トラウマ体験後の生活ストレスであった。
問診・診察のポイント  
  1. 患者はかならずしもPTSD関連症状を主訴として受診するわけではなく、また自らトラウマ体験について打ち明けないこともある。

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文献 

R C Kessler, A Sonnega, E Bromet, M Hughes, C B Nelson
Posttraumatic stress disorder in the National Comorbidity Survey.
Arch Gen Psychiatry. 1995 Dec;52(12):1048-60.
Abstract/Text BACKGROUND: Data were obtained on the general population epidemiology of DSM-III-R posttraumatic stress disorder (PTSD), including information on estimated life-time prevalence, the kinds of traumas most often associated with PTSD, sociodemographic correlates, the comorbidity of PTSD with other lifetime psychiatric disorders, and the duration of an index episode.
METHODS: Modified versions of the DSM-III-R PTSD module from the Diagnostic Interview Schedule and of the Composite International Diagnostic Interview were administered to a representative national sample of 5877 persons aged 15 to 54 years in the part II subsample of the National Comorbidity Survey.
RESULTS: The estimated lifetime prevalence of PTSD is 7.8%. Prevalence is elevated among women and the previously married. The traumas most commonly associated with PTSD are combat exposure and witnessing among men and rape and sexual molestation among women. Posttraumatic stress disorder is strongly comorbid with other lifetime DSM-III-R disorders. Survival analysis shows that more than one third of people with an index episode of PTSD fail to recover even after many years.
CONCLUSIONS: Posttraumatic stress disorder is more prevalent than previously believed, and is often persistent. Progress in estimating age-at-onset distributions, cohort effects, and the conditional probabilities of PTSD from different types of trauma will require future epidemiologic studies to assess PTSD for all lifetime traumas rather than for only a small number of retrospectively reported "most serious" traumas.

PMID 7492257
Fran H Norris, Melissa Tracy, Sandro Galea
Looking for resilience: understanding the longitudinal trajectories of responses to stress.
Soc Sci Med. 2009 Jun;68(12):2190-8. doi: 10.1016/j.socscimed.2009.03.043. Epub 2009 May 4.
Abstract/Text Taking advantage of two large, population-based, and longitudinal datasets collected after the 1999 floods in Mexico (n=561) and the September 11, 2001 terrorist attacks in New York (n=1267), we examined the notion that resilience may be best understood and measured as one member of a set of trajectories that may follow exposure to trauma or severe stress. We hypothesized that resistance, resilience, recovery, relapsing/remitting, delayed dysfunction, and chronic dysfunction trajectories were all possible in the aftermath of major disasters. Semi-parametric group-based modeling yielded the strongest evidence for resistance (no or mild and stable symptoms), resilience (initially moderate or severe symptoms followed by a sharp decrease), recovery (initially moderate or severe symptoms followed by a gradual decrease), and chronic dysfunction (moderate or severe and stable symptoms), as these trajectories were prevalent in both samples. Neither Mexico nor New York showed a relapsing/remitting trajectory, and only New York showed a delayed dysfunction trajectory. Understanding patterns of psychological distress over time may present opportunities for interventions that aim to increase resilience, and decrease more adverse trajectories, after mass traumatic events.

PMID 19403217
K C Koenen, A Ratanatharathorn, L Ng, K A McLaughlin, E J Bromet, D J Stein, E G Karam, A Meron Ruscio, C Benjet, K Scott, L Atwoli, M Petukhova, C C W Lim, S Aguilar-Gaxiola, A Al-Hamzawi, J Alonso, B Bunting, M Ciutan, G de Girolamo, L Degenhardt, O Gureje, J M Haro, Y Huang, N Kawakami, S Lee, F Navarro-Mateu, B-E Pennell, M Piazza, N Sampson, M Ten Have, Y Torres, M C Viana, D Williams, M Xavier, R C Kessler
Posttraumatic stress disorder in the World Mental Health Surveys.
Psychol Med. 2017 Oct;47(13):2260-2274. doi: 10.1017/S0033291717000708. Epub 2017 Apr 7.
Abstract/Text BACKGROUND: Traumatic events are common globally; however, comprehensive population-based cross-national data on the epidemiology of posttraumatic stress disorder (PTSD), the paradigmatic trauma-related mental disorder, are lacking.
METHODS: Data were analyzed from 26 population surveys in the World Health Organization World Mental Health Surveys. A total of 71 083 respondents ages 18+ participated. The Composite International Diagnostic Interview assessed exposure to traumatic events as well as 30-day, 12-month, and lifetime PTSD. Respondents were also assessed for treatment in the 12 months preceding the survey. Age of onset distributions were examined by country income level. Associations of PTSD were examined with country income, world region, and respondent demographics.
RESULTS: The cross-national lifetime prevalence of PTSD was 3.9% in the total sample and 5.6% among the trauma exposed. Half of respondents with PTSD reported persistent symptoms. Treatment seeking in high-income countries (53.5%) was roughly double that in low-lower middle income (22.8%) and upper-middle income (28.7%) countries. Social disadvantage, including younger age, female sex, being unmarried, being less educated, having lower household income, and being unemployed, was associated with increased risk of lifetime PTSD among the trauma exposed.
CONCLUSIONS: PTSD is prevalent cross-nationally, with half of all global cases being persistent. Only half of those with severe PTSD report receiving any treatment and only a minority receive specialty mental health care. Striking disparities in PTSD treatment exist by country income level. Increasing access to effective treatment, especially in low- and middle-income countries, remains critical for reducing the population burden of PTSD.

PMID 28385165
Satoko Hamanaka, Nozomu Asukai, Yoshito Kamijo, Kotaro Hatta, Junji Kishimoto, Hitoshi Miyaoka
Acute stress disorder and posttraumatic stress disorder symptoms among patients severely injured in motor vehicle accidents in Japan.
Gen Hosp Psychiatry. 2006 May-Jun;28(3):234-41. doi: 10.1016/j.genhosppsych.2006.02.007.
Abstract/Text OBJECTIVE: The prevalence of acute stress disorder (ASD) and posttraumatic stress disorder (PTSD) in seriously injured survivors of motor vehicle accidents (MVAs) in Japan was investigated. Furthermore, predictive factors in the early stage for development of PTSD were evaluated.
METHOD: Subjects were consecutive samples (N=100) of patients hospitalized with severe MVA injuries surveyed at two time points: within 1 month after the MVA and then 6 months later. In the first survey, we conducted the Acute Stress Disorder Interview and compiled results of a self-rating questionnaire; in the second survey, we conducted a structured clinical interview via telephone.
RESULTS: The prevalence of ASD and PTSD were 9.0% and 8.5%, respectively. The shift from ASD to PTSD was more pronounced when we included partial diagnoses of ASD and PTSD. Three predictive factors for PTSD were identified through multiple logistic analysis: ASD-positive, presence of persistent physical disability and physical injury severity.
CONCLUSIONS: Even among severely injured MVA survivors, most acute stress symptoms subside over time. However, having ASD or partial ASD in the early stage, and the presence of physical disability as an aftereffect are strong predictive factors for PTSD. These findings validate the importance of evidence-based intervention for ASD to forestall PTSD.

PMID 16675367
M Creamer, P Burgess, A C McFarlane
Post-traumatic stress disorder: findings from the Australian National Survey of Mental Health and Well-being.
Psychol Med. 2001 Oct;31(7):1237-47.
Abstract/Text BACKGROUND: We report on the epidemiology of post-traumatic stress disorder (PTSD) in the Australian community, including information on lifetime exposure to trauma, 12-month prevalence of PTSD, sociodemographic correlates and co-morbidity.
METHODS: Data were obtained from a stratified sample of 10,641 participants as part of the Australian National Survey of Mental Health and Well-being. A modified version of the Composite International Diagnostic Interview was used to determine the presence of PTSD, as well as other DSM-IV anxiety, affective and substance use disorders.
RESULTS: The estimated 12-month prevalence of PTSD was 1-33%, which is considerably lower than that found in comparable North American studies. Although females were at greater risk than males within the subsample of those who had experienced trauma, the large gender differences noted in some recent epidemiological research were not replicated. Prevalence was elevated among the never married and previously married respondents, and was lower among those aged over 55. For both men and women, rape and sexual molestation were the traumatic events most likely to be associated with PTSD. A high level of Axis 1 co-morbidity was found among those persons with PTSD.
CONCLUSIONS: PTSD is a highly prevalent disorder in the Australian community and is routinely associated with high rates of anxiety, depression and substance disorders. Future research is needed to investigate rates among other populations outside the North American continent.

PMID 11681550
C R Brewin, B Andrews, J D Valentine
Meta-analysis of risk factors for posttraumatic stress disorder in trauma-exposed adults.
J Consult Clin Psychol. 2000 Oct;68(5):748-66.
Abstract/Text Meta-analyses were conducted on 14 separate risk factors for posttraumatic stress disorder (PTSD), and the moderating effects of various sample and study characteristics, including civilian/military status, were examined. Three categories of risk factor emerged: Factors such as gender, age at trauma, and race that predicted PTSD in some populations but not in others; factors such as education, previous trauma, and general childhood adversity that predicted PTSD more consistently but to a varying extent according to the populations studied and the methods used; and factors such as psychiatric history, reported childhood abuse, and family psychiatric history that had more uniform predictive effects. Individually, the effect size of all the risk factors was modest, but factors operating during or after the trauma, such as trauma severity, lack of social support, and additional life stress, had somewhat stronger effects than pretrauma factors.

PMID 11068961
Emily J Ozer, Suzanne R Best, Tami L Lipsey, Daniel S Weiss
Predictors of posttraumatic stress disorder and symptoms in adults: a meta-analysis.
Psychol Bull. 2003 Jan;129(1):52-73.
Abstract/Text A review of 2,647 studies of posttraumatic stress disorder (PTSD) yielded 476 potential candidates for a meta-analysis of predictors of PTSD or of its symptoms. From these, 68 studies met criteria for inclusion in a meta-analysis of 7 predictors: (a) prior trauma, (b) prior psychological adjustment, (c) family history of psychopathology, (d) perceived life threat during the trauma, (e) posttrauma social support, (f) peritraumatic emotional responses, and (g) peritraumatic dissociation. All yielded significant effect sizes, with family history, prior trauma, and prior adjustment the smallest (weighted r = .17) and peritraumatic dissociation the largest (weighted r = .35). The results suggest that peritraumatic psychological processes, not prior characteristics, are the strongest predictors of PTSD.

PMID 12555794
Arnold A P van Emmerik, Jan H Kamphuis, Alexander M Hulsbosch, Paul M G Emmelkamp
Single session debriefing after psychological trauma: a meta-analysis.
Lancet. 2002 Sep 7;360(9335):766-71. doi: 10.1016/S0140-6736(02)09897-5.
Abstract/Text BACKGROUND: Despite conflicting research findings and uncertain efficacy, single session debriefing is standard clinical practice after traumatic events. We aimed to assess the efficacy of this intervention in prevention of chronic symptoms of post-traumatic stress disorder and other disorders after trauma.
METHODS: In a meta-analysis, we selected appropriate studies from databases (Medline Advanced, PsychINFO, and PubMed), the Journal of Traumatic Stress, and reference lists of articles and book chapters. Inclusion criteria were that single session debriefing had been done within 1 month after trauma, symptoms were assessed with widely accepted clinical outcome measures, and data from psychological assessments that had been done before (pretest data) and after (post-test data) interventions and were essential for calculation of effect sizes had been reported. We included seven studies in final analyses, in which there were five critical incident stress debriefing (CISD) interventions, three non-CISD interventions, and six no-intervention controls.
FINDINGS: Non-CISD interventions and no intervention improved symptoms of post-traumatic stress disorder, but CISD did not improve symptoms (weighted mean effect sizes 0.65 [95% CI 0.14-1.16], 0.47 [0.28-0.66], and 0.13 [-0.29 to 0.55], respectively). CISD did not improve natural recovery from other trauma-related disorders (0.12 [-0.22 to 0.47]).
INTERPRETATION: CISD and non-CISD interventions do not improve natural recovery from psychological trauma.

PMID 12241834
Nozomu Asukai, Azusa Saito, Nobuko Tsuruta, Junji Kishimoto, Toru Nishikawa
Efficacy of exposure therapy for Japanese patients with posttraumatic stress disorder due to mixed traumatic events: A randomized controlled study.
J Trauma Stress. 2010 Dec;23(6):744-50. doi: 10.1002/jts.20589. Epub 2010 Dec 3.
Abstract/Text The authors examined the efficacy of Prolonged Exposure (PE) therapy in Japanese patients with posttraumatic stress disorder (PTSD). Twenty-four patients (21 women, 3 men) with PTSD due to mixed trauma were randomly assigned to the PE group (PE with or without treatment as usual [TAU]) or the control group (TAU) only. The control group received PE after a 10-week period. Intention-to-treat analysis showed the PE group achieved significantly greater reduction than the control group at posttreatment in either PTSD or depressive symptoms. The control group had significantly decreased symptom severity after PE treatment. Symptom levels of 19 PE completers in the both groups remained low in 12-month follow-up assessments. The study's findings will promote the future dissemination and implementation of evidence-based treatment for PTSD in non-Western settings.

Copyright © 2010 International Society for Traumatic Stress Studies.
PMID 21171135
Satomi Kameoka, Eizaburo Tanaka, Sayaka Yamamoto, Azusa Saito, Tomomi Narisawa, Yoko Arai, Sachiko Nosaka, Kayoko Ichikawa, Nozomu Asukai
Effectiveness of trauma-focused cognitive behavioral therapy for Japanese children and adolescents in community settings: a multisite randomized controlled trial.
Eur J Psychotraumatol. 2020 Jul 1;11(1):1767987. doi: 10.1080/20008198.2020.1767987. Epub 2020 Jul 1.
Abstract/Text Background: Trauma-focused cognitive behavioural therapy (TF-CBT) is an efficacious treatment model for children and adolescents with trauma-related disorders. However, few studies have been conducted in community settings, and there have been no randomized controlled trials in Asian countries.
Objective: To evaluate the effectiveness of TF-CBT in regular community settings in Japan through comparison with a waitlist with minimal services control condition.
Method: Thirty Japanese children and adolescents with posttraumatic stress disorder symptoms (22 females, eight males, mean age = 13.90, range = 6-18) were randomly assigned to 12 sessions of TF-CBT or the waitlist control condition. The primary outcome measure was the Kiddie Schedule for Affective Disorders and Schizophrenia score assessed by blinded evaluators one month later.
Results: The mean number of sessions was 12 (range: 11-13) in the TF-CBT group and 4.87 (range: 3-7) in the control group. Intention to treat analysis showed that the TF-CBT group achieved significantly greater symptom reduction than did the control group. The effect size (Cohen's d) between the TF-CBT and control groups was 0.96 (p =.014) for posttraumatic symptoms and 1.15 (p =.004) for depressive symptoms. However, the TF-CBT group did not show better results than the control group with regard to improvements in anxiety symptoms, psychosocial functioning, and behavioural problems.
Conclusions: The findings provided preliminary evidence of the effectiveness of TF-CBT for treating youth with trauma in community mental health facilities. TF-CBT in the Japanese context proved identical to the original, demonstrating that it is also suitable for use with children and adolescents in non-Western settings.

© 2020 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.
PMID 33029313
Yoshiharu Kim, Nozomu Asukai, Takako Konishi, Hiroshi Kato, Hideto Hirotsune, Masaharu Maeda, Hirotaka Inoue, Hiroyasu Narita, Masaru Iwasaki
Clinical evaluation of paroxetine in post-traumatic stress disorder (PTSD): 52-week, non-comparative open-label study for clinical use experience.
Psychiatry Clin Neurosci. 2008 Dec;62(6):646-52. doi: 10.1111/j.1440-1819.2008.01862.x.
Abstract/Text AIM: The present study was a 52-week, non-comparative, open-label study of flexible dose paroxetine (20-40 mg) in 52 Japanese post-traumatic stress disorder (PTSD) patients in order to obtain clinical experience regarding efficacy and safety in regular clinical practice.
METHODS: Efficacy was measured using the Clinician-Administered PTSD Scale One Week Symptom Status Version (CAPS-SX).
RESULTS: The mean change from baseline in CAPS-SX total score was -19.1, -22.8 and -32.3 at weeks 4, 12 and 52, respectively, and that in the Clinical Global Impression (CGI) Severity of Illness score was -1.1 at week 12 and -1.7 at week 52. A total of 46.9% were CGI responders at week 12, while 67.3% were improved on the CGI at week 52. Of 52 subjects who entered into the drug treatment, 25 completed the study. Only one patient withdrew from the study due to lack of efficacy. In patients who were rated as 'moderately ill' or less at baseline, the proportion of CGI responders at end-point was higher at a dose of 20 mg/day than at higher doses, whereas in patients rated as 'markedly ill' or more, it was higher at 30 and 40 mg/day, suggesting that severely ill patients could benefit from higher doses.
CONCLUSION: Paroxetine appeared generally tolerated in short- and long-term use, and the safety profile in this study was consistent with international trials and other Japanese populations (i.e. patients suffering from depression, panic disorder or obsessive-compulsive disorder). Although the study was not conducted in double-blind fashion, the current findings suggest that paroxetine may contribute to clinically meaningful improvement that is maintained during long-term use and is generally well tolerated.

PMID 19068000
J Davidson, T Pearlstein, P Londborg, K T Brady, B Rothbaum, J Bell, R Maddock, M T Hegel, G Farfel
Efficacy of sertraline in preventing relapse of posttraumatic stress disorder: results of a 28-week double-blind, placebo-controlled study.
Am J Psychiatry. 2001 Dec;158(12):1974-81.
Abstract/Text OBJECTIVE: The study examined the efficacy of sertraline, compared with placebo, in sustaining improvement and preventing relapse over 28 weeks in patients with posttraumatic stress disorder (PTSD) who had completed a 12-week double-blind, placebo-controlled acute treatment study and a subsequent 24-week open-label study of continuation treatment with sertraline.
METHOD: Ninety-six patients were randomly assigned, in a double-blind design, to 28 weeks of maintenance treatment with sertraline (50-200 mg, N=46; 78% were women) or placebo (N=50; 62% were women). Measures used in biweekly assessments included the Clinician-Administered PTSD Scale, the Impact of Event Scale, and the Clinical Global Impression severity and improvement ratings. Kaplan-Meier analyses were used to estimate time to discontinuation from the study due to relapse, relapse or study discontinuation due to clinical deterioration, and acute exacerbation.
RESULTS: Continued treatment with sertraline yielded lower PTSD relapse rates than placebo (5% versus 26%). Patients who received placebo were 6.4 times as likely to experience relapse as were patients who received sertraline. Kaplan-Meier analyses confirmed the protective effect of sertraline in significantly extending time in remission. The ability of sertraline to sustain improvement was comparable across the three core PTSD symptom clusters (reexperiencing/intrusion, avoidance/numbing, and hyperarousal). A regression analysis found early response during acute treatment to be associated with a more than 16-fold reduced risk of relapse after placebo substitution. Sertraline, at a mean endpoint dose of 137 mg, was well tolerated, with no sertraline-related adverse events observed at a rate of 10% or higher.
CONCLUSIONS: The results provide evidence for the ability of sertraline both to sustain improvement in PTSD symptoms and to provide prophylactic protection against relapse.

PMID 11729012
P Braun, D Greenberg, H Dasberg, B Lerer
Core symptoms of posttraumatic stress disorder unimproved by alprazolam treatment.
J Clin Psychiatry. 1990 Jun;51(6):236-8.
Abstract/Text The authors report a random-assignment, double-blind crossover trial comparing alprazolam and placebo in posttraumatic stress disorder (PTSD). Ten patients fulfilling DSM-III criteria for PTSD completed 5 weeks of treatment on each agent. Improvement in anxiety symptoms was significantly greater during alprazolam treatment but modest in extent. Symptoms specific to PTSD were not significantly altered. The impact of nonspecific symptomatic effects on the outcome of drug trials in PTSD is considered.

PMID 2189869
Takehiro Numata, Shen Gunfan, Shin Takayama, Satomi Takahashi, Yasutake Monma, Soichiro Kaneko, Hitoshi Kuroda, Junichi Tanaka, Seiki Kanemura, Masayuki Nara, Yutaka Kagaya, Tadashi Ishii, Nobuo Yaegashi, Masahiro Kohzuki, Koh Iwasaki
Treatment of posttraumatic stress disorder using the traditional Japanese herbal medicine saikokeishikankyoto: a randomized, observer-blinded, controlled trial in survivors of the great East Japan earthquake and tsunami.
Evid Based Complement Alternat Med. 2014;2014:683293. doi: 10.1155/2014/683293. Epub 2014 Mar 24.
Abstract/Text The Great East Japan earthquake and tsunami caused immense damage over a wide area of eastern Japan. Hence, many survivors are at high risk for posttraumatic stress disorder (PTSD). This randomized, observer-blinded, controlled trial examined the efficacy and safety of the traditional Japanese herbal formula saikokeishikankyoto (SKK) in the treatment of PTSD among survivors of this disaster. Forty-three participants with an Impact of Event Scale-Revised (IES-R) score ≥ 25 were randomized into SKK (n = 21) and control (n = 22) groups. The primary endpoint was the change in IES-R scores from baseline till after 2 weeks of treatment. Intergroup statistical comparisons were performed. The magnitude of changes in total IES-R scores differed significantly between the two groups (P < 0.001). Post hoc analysis showed that the total IES-R score improved significantly in the SKK group from 49.6 ± 11.9 to 25.5 ± 17.0 (P < 0.001). Subscale scores improved significantly in the SKK group (avoidance, P = 0.003; hyperarousal, P < 0.001; intrusion, P < 0.001). Two-week treatment with SKK significantly improved IES-R scores among PTSD patients. This traditional medicine may be a valid choice for the treatment of psychological and physical symptoms in PTSD patients.

PMID 24790634
Barbara O Rothbaum, Shawn P Cahill, Edna B Foa, Jonathan R T Davidson, Jill Compton, Kathryn M Connor, Millie C Astin, Chang-Gyu Hahn
Augmentation of sertraline with prolonged exposure in the treatment of posttraumatic stress disorder.
J Trauma Stress. 2006 Oct;19(5):625-38. doi: 10.1002/jts.20170.
Abstract/Text The present study was designed to determine whether augmenting sertraline with prolonged exposure (PE) would result in greater improvement than continuation with sertraline alone. Outpatient men and women with chronic PTSD completed 10 weeks of open label sertraline and then were randomly assigned to five additional weeks of sertraline alone (n = 31) or sertraline plus 10 sessions of twice-weekly PE (n = 34). Results indicated that sertraline led to a significant reduction in PTSD severity after 10 weeks but was associated with no further reductions after five more weeks. Participants who received PE showed further reduction in PTSD severity. This augmentation effect was observed only for participants who showed a partial response to medication.

PMID 17075912
Naomi M Simon, Kathryn M Connor, Ariel J Lang, Sheila Rauch, Stan Krulewicz, Richard T LeBeau, Jonathan R T Davidson, Murray B Stein, Michael W Otto, Edna B Foa, Mark H Pollack
Paroxetine CR augmentation for posttraumatic stress disorder refractory to prolonged exposure therapy.
J Clin Psychiatry. 2008 Mar;69(3):400-5.
Abstract/Text OBJECTIVE: Little is known about the efficacy of "next step" strategies for patients with post-traumatic stress disorder (PTSD) who remain symptomatic despite treatment. This study prospectively examines the relative efficacy of augmentation of continued prolonged exposure therapy (PE) with paroxetine CR versus placebo for individuals remaining symptomatic despite a course of PE.
METHOD: Adult outpatients meeting DSM-IV criteria for PTSD were recruited from February 2003 to September 2005 at 4 academic centers. Phase I consisted of 8 sessions of individual PE over a 4- to 6-week period. Participants who remained symptomatic, defined as a score of >or= 6 on the Short PTSD Rating Interview (SPRINT) and a Clinical Global Impressions-Severity of Illness scale (CGI-S) score >or= 3, were randomly assigned to the addition of paroxetine CR or matched placebo to an additional 5 sessions of PE (Phase II).
RESULTS: Consistent with prior studies, the 44 Phase I completers improved significantly with initial PE (SPRINT: paired t = 7.6, df = 41, p < .0001; CGI-S: paired t = 6.37, df = 41, p < .0001). Counter to our hypothesis, however, we found no additive benefit of augmentation of continued PE with paroxetine CR compared to pill placebo for the 23 randomly assigned patients, with relatively minimal further gains overall in Phase II.
CONCLUSION: Although replication with larger samples is needed before definitive conclusions can be drawn, our data do not support the addition of paroxetine CR compared with placebo to continued PE for individuals with PTSD who remain symptomatic after initial PE, suggesting that the development of novel treatment approaches for PTSD refractory to PE is needed.
CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov identifier NCT00215163.

PMID 18348595
Agnieszka Popiel, Bogdan Zawadzki, Ewa Pragłowska, Yona Teichman
Prolonged exposure, paroxetine and the combination in the treatment of PTSD following a motor vehicle accident. A randomized clinical trial - The "TRAKT" study.
J Behav Ther Exp Psychiatry. 2015 Sep;48:17-26. doi: 10.1016/j.jbtep.2015.01.002. Epub 2015 Jan 28.
Abstract/Text BACKGROUND AND OBJECTIVE: Little is known about direct comparisons of the efficacy of trauma-focused psychotherapies and SSRIs. This is the first randomized clinical trial comparing the efficacy of prolonged exposure (PE), paroxetine (Ph) and their combination (Comb) in a sample of adults diagnosed with PTSD following motor vehicle accidents (MVA).
METHODS: A total of 228 people were randomly assigned to a twelve-week treatment of PE (N = 114), Ph (N = 57) or Comb (N = 57).
RESULTS: The ITT analyses showed that the remission rate of PTSD was significantly greater after PE (65.5%) compared with Ph (43.3%), whereas Comb (51.2%) did not differ from either. The differences in dropout rates were not significant between treatments (18.4% - PE; 12.2% - Ph; 22.8% - Comb), while the differences in numbers of refusers were significant (3.5% PE <31.6% Comb <47.4% Ph; p < .01). The changes in self-rated PTSD were significant for each treatment and without significant differences between treatments. Differences between clinician and self-rated outcomes can be explained by depressive symptoms influencing self-rating by the PDS. At a 12 month follow-up treatment results were maintained and different trajectories of functioning were identified.
LIMITATIONS: Larger samples would allow analyses of predictors of treatment response, dropout and refusal.
CONCLUSIONS: In this, largest to date study comparing PE, paroxetine and combination treatment in PTSD PE was more effective than Ph in achieving remission of PTSD. The additive effect of Comb over any monotherapy was not shown.

Copyright © 2015 Elsevier Ltd. All rights reserved.
PMID 25677254

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