期刊论文详细信息
BMC Psychiatry
Comparison of the effectiveness of trauma-focused cognitive behavioral therapy and paroxetine treatment in PTSD patients: Design of a randomized controlled trial
Miranda Olff4  Damiaan Denys1  Martijn Figee2  Nienke Vulink2  Brent C Opmeer3  Rogier S Visser2  Anke B Witteveen2  A Rosaura Polak2 
[1] The Netherlands Institute for Neuroscience (NIN), an institute of the Royal Netherlands Academy of Arts and Sciences, Meibergdreef 47, Amsterdam, 1105 BA, The Netherlands;Academic Medical Center (AMC), Department of Anxiety Disorders, University of Amsterdam (UvA), Meibergdreef 5, Amsterdam, 1105 AZ, The Netherlands;Academic Medical Center (AMC), Clinical Research Unit, University of Amsterdam, Meibergdreef 5, Amsterdam, 1105 AZ, The Netherlands;Arq Psychotrauma Expert Group the Netherlands, Nienoord 5, Diemen, 1112 XE, The Netherlands
关键词: Cost-effectiveness;    Effectiveness;    Paroxetine;    TF-CBT;    PTSD;   
Others  :  1124265
DOI  :  10.1186/1471-244X-12-166
 received in 2012-05-31, accepted in 2012-09-27,  发布年份 2012
PDF
【 摘 要 】

Background

The two most common interventions for Posttraumatic Stress Disorder (PTSD) are pharmacological treatment with SSRIs such as paroxetine and psychological treatment such as Trauma-Focused Cognitive Behavioral Therapy (TF-CBT). International guidelines recommend trauma-focused psychological interventions for all PTSD patients as first-line treatment (NICE). However, no clear-cut evidence is available to support this recommendation.

Methods/design

In order to compare pharmacological treatment (paroxetine) and psychological treatment (TF-CBT) in (cost-) effectiveness on the short and the long term, we will randomize 90 patients with chronic PTSD to either paroxetine (24 weeks) or TF-CBT (10–12 weeks). We will assess symptom severity and costs before and after the intervention with the Clinician Administered PTSD Scale (CAPS), the Clinical Global Impression Scale (CGI) and the Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TiC-P).

Discussion

This study is unique for its direct comparison of the most commonly used psychological intervention (TF-CBT) and pharmacological intervention (paroxetine) on (cost-) effectiveness on the short and the long term. The anticipated results will provide relevant evidence concerning long-term effects and relapse rates and will be beneficial in reducing societal costs. It may also provide information on who may benefit most from which type of intervention. Some methodological issues will be discussed.

Trial Registration

Dutch Trial registration: NTR2235

【 授权许可】

   
2012 Polak et al.; licensee BioMed Central Ltd.

【 预 览 】
附件列表
Files Size Format View
20150216065332486.pdf 267KB PDF download
Figure 1. 20KB Image download
【 图 表 】

Figure 1.

【 参考文献 】
  • [1]De Vries GJ, Olff M: The lifetime prevalence of traumatic events and posttraumatic stress disorder in the Netherlands. J Trauma Stress 2009, 22(Suppl 4):259-267.
  • [2]Kessler RC, Sonnega A, Bromet E, Hughes M, Nelson CB: Posttraumatic stress disorder in the national comorbidity survey. Arch Gen Psychiatry 1995, 52(Suppl 12):1048-1060.
  • [3]Breslau N, Davis GC, Andreski P, Peterson EL, Schultz LR: Sex differences in posttraumatic stress disorder. Arch Gen Psychiatry 1997, 54(Suppl 11):1044-1048.
  • [4]Stein MB, Walker JR, Forde DR: Gender differences in susceptibility to posttraumatic stress disorder. Behavioral Research and Therapy 2000, 38:619-628.
  • [5]Olff M, Langeland W, Draijer N, Gersons BP: Gender differences in posttraumatic stress disorder. Psychol Bull 2007, 133(Suppl 2):183-204.
  • [6]Zatzick DF, Marmar CR, Weiss DS, Browner WS, Metzler TJ, Golding JM, Stewart A, Schlenger WE, Wells KB: Posttraumatic stress disorder and functioning and quality of life outcomes in a nationally representative sample of male Vietnam veterans. Am J Psychiatry 1997, 154(Suppl 12):1690-1695.
  • [7]Walker EA, Katon W, Russo J, Ciechanowski P, Newman E, Wagner AW: Health care costs associated with posttraumatic stress disorder symptoms in women. Arch Gen Psychiatry 2003, 60:369-374.
  • [8]Trimbos Instituut: Multidisciplinaire richtlijn angststoornissen. Landelijke stuurgroep multidisciplinaire richtlijnontwikkeling in de GGZ. Ref Type. Generic 2009.
  • [9]National Institute for Clinical Excellence (NICE): Post-traumatic stress disorder, the management of PTSD in adults and children in primary and secondary care. London: Gaskell and the British Psychological Society; 2005.
  • [10]Rothbaum BO, Astin MC, Marsteller F: Prolonged exposure versus eye movement desensitization and reprocessing (EMDR) for PTSD rape victims. J Trauma Stress 2005, 18(Suppl 6):607-616.
  • [11]Van der Kolk BA, Spinazzola J, Blaustein ME, Hopper JW, Hopper EK, Korn DL, Simpson WB: A randomized clinical trial of eye movement desensitization and reprocessing (EMDR), fluoxetine, and pill placebo in the treatment of posttraumatic stress disorder: treatment effects and long-term maintenance. J Clin Psychiatry 2007, 68(Suppl 1):37-46.
  • [12]Nijdam MJ, Gersons BP, Reitsma JB, Jongh A, Olff M: Brief eclectic psychotherapy v. eye movement desensitisation and reprocessing therapy in the treatment of post-traumatic stress disorder: randomised controlled trial. Br J Psychiatry 2012, 200(Suppl 3):224-231.
  • [13]Seidler GH, Wagner FE: Comparing the efficacy of EMDR and trauma-focused cognitive-behavioral therapy in the treatment of PTSD: a meta-analytic study. Psychol Med 2006, 36(Suppl 11):1515-1522.
  • [14]Bisson J, Andrew M: Psychological treatment of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev 2007, (3):CD003388.
  • [15]Marshall RD, Beebe KL, Oldham M, Zaninelli R: Efficacy and safety of paroxetine treatment for chronic PTSD: a fixed-dose, placebo-controlled study. Am J Psychiatry 2001, 158(Suppl 12):1982-1988.
  • [16]Tucker P, Zaninelli R, Yehuda R, Ruggiero L, Dillingham K, Pitts CD: Paroxetine in the treatment of chronic posttraumatic stress disorder: results of a placebo-controlled, flexible-dosage trial. J Clin Psychiatry 2001, 62(Suppl 11):860-868.
  • [17]Brady K, Pearlstein T, Asnis GM, Baker D, Rothbaum B, Sikes CR, Farfel GM: Efficacy and safety of sertraline treatment of posttraumatic stress disorder: a randomized controlled trial. JAMA 2000, 283(Suppl 14):1837-1844.
  • [18]Davidson JR, Rothbaum BO, van der Kolk BA, Sikes CR, Farfel GM: Multicenter, double-blind comparison of sertraline and placebo in the treatment of posttraumatic stress disorder. Arch Gen Psychiatry 2001, 58(Suppl 5):485-492.
  • [19]Van der Kolk BA, Dreyfuss D, Michaels M, Shera D, Berkowitz R, Fisler R, Saxe G: Fluoxetine in posttraumatic stress disorder. J Clin Psychiatry 1994, 55(Suppl 12):517-522.
  • [20]Connor KM, Sutherland SM, Tupler LA, Malik ML, Davidson JR: Fluoxetine in post-traumatic stress disorder. Randomised, double-blind study. Br J Psychiatry 1999, 175:17-22.
  • [21]Martenyi F, Brown EB, Zhang H, Prakash A, Koke SC: Fluoxetine versus placebo in posttraumatic stress disorder. J Clin Psychiatry 2002, 63(Suppl 3):199-206.
  • [22]Stein DJ, Ipser JC, Seedat S: Pharmacotherapy for post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev 2006, (1):CD002795.
  • [23]Ipser JC, Stein DJ: Evidence-based pharmacotherapy of post-traumatic stress disorder (PTSD). Int J Neuropsychopharmacol 2012, 15(Suppl 6):825-840.
  • [24]Stein DJ, Ipser J, McAnda N: Pharmacotherapy of post- traumatic stress disorder: a review of meta-analyses and treatment guidelines. CNS Spectr 2009, 14(Suppl 1):25-31.
  • [25]Van Minnen A, Hendriks L, Olff M: When do trauma experts choose exposure therapy for PTSD patients? A controlled study of therapist and patient factors. Behav Res Ther 2010, 48(Suppl 4):312-320.
  • [26]Mellman TA, Clark RE, Peacock WJ: Prescribing patterns for patients with posttraumatic stress disorder. Psychiatr Serv 2003, 54(Suppl 12):1618-1621.
  • [27]Van Etten ML, Taylor S: Comparative efficacy of treatments for posttraumatic stress-disorder: a meta-analysis. Clin Psychol Psychother 1998, 5:126-144.
  • [28]Frommberger U, Stieglitz RD, Nyberg E, Richter H, Novelli-Fischer U, Angenendt JA, Zaninelli R, Berger M: Comparison between paroxetine and behaviour therapy in patients with posttraumatic stress disorder (PTSD): A pilot study. Int J Psychiatry Clin Pract 2004, 8:19-23.
  • [29]Martenyi F, Brown EB, Zhang H, Koke SC, Prakash A: Fluoxetine v. placebo in prevention of relapse in post-traumatic stress disorder. Br J Psychiatry 2002, 181:315-320.
  • [30]Londborg PD, Hegel MT, Goldstein S, Goldstein D, Himmelhoch JM, Maddock R, Patterson WM, Rausch J, Farfel GM: Sertraline treatment of posttraumatic stress disorder: results of 24 weeks of open-label continuation treatment. J Clin Psychiatry 2001, 62(Suppl 5):325-331.
  • [31]Davidson J, Pearlstein T, Londborg P, Brady KT, Rothbaum B, Bell J, Maddock R, Hegel MT, Farfel G: Efficacy of sertraline in preventing relapse of posttraumatic stress disorder: results of a 28-week double-blind, placebo-controlled study. Am J Psychiatry 2001, 158(Suppl 12):1974-1981.
  • [32]Kim Y, Asukai N, Konishi T, Kato H, Hirotsune H, Maeda M, Inoue H, Narita H, Iwasaki M: 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, 62(Suppl 6):646-652.
  • [33]Ballenger JC, Davidson JR, Lecrubier Y, Nutt DJ, Marshall RD, Nemeroff CB, Shalev AY, Yehuda R: Consensus statement update on posttraumatic stress disorder from the international consensus group on depression and anxiety. J Clin Psychiatry 2004, 65(Suppl 1):55-62.
  • [34]Powers MB, Halpern JM, Ferenschak MP, Gillihan SJ, Foa EB: A meta-analytic review of prolonged exposure for posttraumatic stress disorder. Clin Psychol Rev 2010, 30(Suppl 6):635-641.
  • [35]Bradley R, Greene J, Russ E, Dutra L, Westen D: A multidimensional meta-analysis of psychotherapy for PTSD. Am J Psychiatry 2005, 162:214-227.
  • [36]American Psychiatric Association: Diagnostic and statistical manual of mental disorders: DSM-IV. Washington, D.C.: Author; 1994.
  • [37]Blake DD, Weathers FW, Nagy LM, Kaloupek DG, Gusman FD, Charney DS, Keane TM: The development of a Clinician-Administered PTSD Scale. J Trauma Stress 1995, 8(Suppl 1):75-90.
  • [38]Blanchard EB, Hickling EJ, Devineni T, Veazey CH, Galovski TE, Mundy E, Malta LS, Buckley TC: A controlled evaluation of cognitive behavioural therapy for posttraumatic stress in motor vehicle accident survivors. Behavioral Research and Therapy 2003, 41(Suppl 1):79-96.
  • [39]Rochon J: Sample size calculations for two-group repeated-measures experiments. Biometrics 1991, 47:1383-1398.
  • [40]Foa EB, Hearst-Ikeda D, Perry KJ: Evaluation of a brief cognitive-behavioral program for the prevention of chronic PTSD in recent assault victims. J Consult Clin Psychol 1995, 63(Suppl 6):948-955.
  • [41]Creamer M, Forbes D, Phelps A, Humphreys L: Treating Traumatic Stress: Conducting imaginal exposure in PTSD. Australian Centre for Posttraumatic Mental Health; 2005.
  • [42]Weiss DS, Marmar CR: The Impact of Event Scale-Revised. In Assessing psychological trauma and PTSD. Edited by Wilson JP, Keane TM. New York: Guilford Press; 1997:399-411.
  • [43]Morisky DE, Ang A, Krousel-Wood M, Ward HJ: Predictive validity of a medication adherence measure in an outpatient setting. Journal of Clinical Hypertension (Greenwich) 2008, 10(Suppl 5):348-354.
  • [44]Weathers FW, Keane TM, Davidson JR: Clinician-administered PTSD scale: a review of the first ten years of research. Depress Anxiety 2001, 13(Suppl 3):132-156.
  • [45]Hovens JE, van der Ploeg HM, Klaarenbeek MT, Bramsen I, Schreuder JN, Rivero VV: The assessment of posttraumatic stress disorder: with the clinician administered PTSD Scale: dutch results. J Clin Psychol 1994, 50(Suppl 3):325-340.
  • [46]Guy W: ECDEU Assessment for Psychopharmacology, revised edition. Rockville, MD: NIMH Publication; 1976.
  • [47]Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC: The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry 1998, 59(Suppl 20):22-33.
  • [48]Van Vliet IM, de Beurs E: [The MINI-International Neuropsychiatric Interview. A brief structured diagnostic psychiatric interview for DSM-IV en ICD-10 psychiatric disorders]. Tijdschr Psychiatr 2007, 46(Suppl 6):393-397.
  • [49]Hakkaart-van Roijen L: Handleiding Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TiC-P). Rotterdam: Institute for Medical Technology Assessment; 2002.
  • [50]Oostenbrink JB, Bouwmans CAM, Koopmanschap MA, Rutten FFH: Handleiding voor kostenonderzoek. Methoden en standaard kostprijzen voor economische evaluaties in de gezondheidszorg. Diemen: College voor zorgverzekeringen; 2004.
  • [51]Van Loenen AC: Farmacotherapeutisch kompas (in Dutch). College of healthcare Insurance; 2007.
  • [52]WHOQOL GROUP: Development of the world health organization WHOQOL-BREF quality of life assessment. Psychol Med 1998, 28:551-558.
  • [53]Trompenaars FJ, Masthoff ED, Van Heck GL, Hodiamont PP, De Vries J: Content validity, construct validity, and reliability of the WHOQOL-Bref in a population of Dutch adult psychiatric outpatients. Qual Life Res 2005, 14(Suppl 1):151-160.
  • [54]Hoeymans N, van Lindert H, Westert GP: The health status of the Dutch population as assessed by the EQ-6D. Qual Life Res 2005, 14(Suppl 3):655-663.
  • [55]Brooks R: EuroQol: The current state of play. Health Policy 1996, 37(Suppl 1):53-72.
  • [56]Dolan P: Aggregating health state valuations. Journal of Health Service Research Policy 1997, 2(Suppl 3):160-165.
  • [57]Zigmond AS, Snaith RP: The hospital anxiety and depression scale. Acta Psychiatr Scand 1983, 67(Suppl 6):361-370.
  • [58]Spinhoven P, Ormel J, Sloekers PP, Kempen GI, Speckens AE, Van Hemert AM: A validation study of the hospital anxiety and depression scale (HADS) in different groups of Dutch subjects. Psychol Med 1997, 27(Suppl 2):363-370.
  • [59]Carlier IV, Voerman BE, Gersons BP: Intrusive traumatic recollections and comorbid posttraumatic stress disorder in depressed patients. Psychosom Med 2000, 62(Suppl 1):26-32.
  • [60]Mouthaan J, Sijbrandij M, Gersons BPR, Olff M: Prognostic screening for posttraumatic stress disorder: a comparison between the SPAN, trauma screening questionnaire and impact of event scale-revised. In preparation
  • [61]Saunders JB, Aasland OG, Babor TF, de la Fuente JR, Grant M: Development of the alcohol use disorders identification test (AUDIT): WHO collaborative project on early detection of persons with harmful alcohol consumption–II. Addiction 1993, 88(Suppl 6):791-804.
  • [62]Ursin H, Endresen IM, Ursin G: Psychological factors and self-reports of muscle pain. Eur J Appl Physiol Occup Physiol 1988, 57(Suppl 3):282-290.
  • [63]Eriksen HR, Ihlebaek C, Ursin H: A scoring system for subjective health complaints (SHC). Scand J Public Health 1999, 27(Suppl 1):63-72.
  • [64]Breslau N, Kessler RC, Chilcoat HD, Schultz LR, Davis GC, Andreski P: Trauma and posttraumatic stress disorder in the community: the 1996 Detroit Area Survey of Trauma. Arch Gen Psychiatry 1998, 55(Suppl 7):626-32.
  • [65]Gold MR, Siegel JE, Russell LB, Weinstein MC (Eds): Cost-Effectiveness in Health and Medicine: Report of the Panel on Cost-Effectiveness in Health and Medicine. New York, NY: Oxford University Press; 1996.
  • [66]Koopmans GT, Lamers LM: Assessing the construct validity of three indicators of psychological distress in relation to perceived health and physical illness. Soc Psychiatry Psychiatr Epidemiol 2005, 40(Suppl 12):1012-1018.
  • [67]Hetrick SE, Purcell R, Garner B, Parslow R: Combined pharmacotherapy and psychological therapies for post traumatic stress disorder (PTSD). Cochrane Database Syst Rev 2010, (7):CD007316.
  • [68]Pratchett LC, Daly K, Bierer LM, Yehuda R: New approaches to combining pharmacotherapy and psychotherapy for posttraumatic stress disorder. Expert Opin Pharmacother 2011, 12(Suppl 15):2339-2354.
  文献评价指标  
  下载次数:10次 浏览次数:4次