Top

Trials

Published in:

Open Access 01-12-2022 | Study protocol

Trauma-focused EMDR for Personality disorders among Outpatients (TEMPO): study protocol for a multi-centre, single-blind, randomized controlled trial

Authors: Simon Hofman, Laurian Hafkemeijer, Ad de Jongh, Annemieke Starrenburg, Karin Slotema

Published in: Trials | Issue 1/2022

Abstract

Background

Existing recommended treatment options for personality disorders (PDs) are extensive and costly. There is emerging evidence indicating that trauma-focused treatment using eye movement desensitization and reprocessing (EMDR) therapy aimed at resolving memories of individuals’ adverse events can be beneficial for this target group within a relatively short time frame. The primary purpose of the present study is to determine the effectiveness of EMDR therapy versus waiting list in reducing PD symptom severity. Furthermore, the effects of EMDR therapy on trauma symptom severity, loss of diagnosis, personal functioning, quality of life, and mental health outcomes will be determined. In addition, the cost-effectiveness of EMDR therapy in the treatment of PDs is investigated. Moreover, predictors of treatment success, symptom deterioration and treatment discontinuation will be assessed. Lastly, experiences with EMDR therapy will be explored.

Method

In total, 159 patients with a PD will be included in a large multicentre single-blind randomized controlled trial. The Structured Clinical Interview for DSM-5 Personality Disorders will be used to determine the presence of a PD. Participants will be allocated to either a treatment condition with EMDR therapy (ten biweekly 90-min sessions) or a waiting list. Three months after potential treatment with EMDR therapy, patients can receive treatment as usual for their PD. All participants are subject to single-blinded baseline, post-intervention and 3-, 6- and 12-month follow-up assessments. The primary outcome measures are the Assessment of DSM-IV Personality Disorders and the Clinician-Administered PTSD Scale for DSM-5. For cost-effectiveness, the Treatment Inventory of Costs in Patients with psychiatric disorders, EuroQol-5D-3L, and the Mental Health Quality of Life Questionnaire will be administered. The PTSD Checklist for DSM-5, Brief State Paranoia Checklist and Difficulties in Emotion Regulation Scale will be used to further index trauma symptom severity. Type of trauma is identified at baseline with the Childhood Trauma Questionnaire-SF and Life Events Checklist for the DSM-5. Personal functioning and health outcome are assessed with the Level of Personality Functioning Scale-BF 2.0, Outcome Questionnaire-45 and Mental Health Quality of Life Questionnaire. Experiences with EMDR therapy of patients in the EMDR therapy condition are explored with a semi-structured interview at post-intervention.

Discussion

It is expected that the results of this study will contribute to knowledge about the effectiveness, and cost-effectiveness of trauma-focused treatment using EMDR therapy in individuals diagnosed with a PD. Follow-up data provide documentation of long-term effects of EMDR therapy on various outcome variables, most importantly the reduction of PD symptom severity and loss of diagnoses.

Trial registration

Netherlands Trial Register NL9078. Registered on 31 November 2020

Available only for authorised users

American Psychiatric Association. Diagnostic and statistical manual of mental disorders. 5th ed. Washington, DC: Author; 2013. https://doi.org/10.1176/appi.books.9780890425596.CrossRef

American Psychiatric Association (2017). SCID-5-P Gestructureerd klinisch interview voor DSM-5 Persoonlijkhiedsstoornissen. Nederlandse vertaling van Structured Clinical Interview for DSM-5® Personality Disorders (SCID-5-P), en User’s Guide for the Structured Clinical Interview for DSM-5® Personality Disorders (SCID-5-P), first. Amsterdam: Boom.

Arntz A, Stupar-Rutenfrans S, Bloo J, van Dyck R, Spinhoven P. Prediction of treatment discontinuation and recovery from borderline personality disorder: results from a RCT comparing schema therapy and transference focused psychotherapy. Behav Res Ther. 2015;74:60–71. https://doi.org/10.1016/j.brat.2015.09.002.CrossRefPubMed

Baddeley A. Working memory: theories, models, and controversies. Ann Rev Psychol. 2012;63:12.1–12.29. https://doi.org/10.1146/annurev-psych-120710-100422.CrossRef

Barnicot K, Katsakou C, Bhatti N, Savill M, Fearns N, Priebe S. Factors predicting the outcome of psychotherapy for borderline personality disorder: a systematic review. Clin Psychol Rev. 2012;32(5):400–12. https://doi.org/10.1016/j.cpr.2012.04.004.CrossRefPubMed

Bateman A, Fonagy P. Effectiveness of partial hospitalization in the treatment of borderline personality disorder: a randomized controlled trial. Am J Psychiatry. 1999;156(10):1563–9. https://doi.org/10.1176/ajp.156.10.1563.CrossRefPubMed

Battle CL, Shea MT, Johnson DM, Yen S, Zlotnick C, Zanarini MC, et al. Childhood maltreatment associated with adult personality disorders: findings from the Collaborative Longitudinal Personality Disorders Study. J Pers Disord. 2004;18(2):193–211. https://doi.org/10.1521/pedi.18.2.193.32777.CrossRefPubMed

Bernstein DP, Stein JA, Newcomb MD, Walker E, Pogge D, Ahluvalia T, et al. Development and validation of a brief screening version of the Childhood Trauma Questionnaire. Child Abuse Neglect. 2003;27(2):169–90. https://doi.org/10.1016/S0145-2134(02)00541-0.CrossRefPubMed

Bisson JI, Berliner L, Cloitre M, Forbes D, Jensen TK, Lewis C, et al. The international society for traumatic stress studies new guidelines for the prevention and treatment of posttraumatic stress disorder: methodology and development process. J Trauma Stress. 2019;32(4):475–83. https://doi.org/10.1002/jts.22421.CrossRefPubMed

10.

Blevins CA, Weathers FW, Davis MT, Witte TK, Domino JL. The posttraumatic stress disorder checklist for DSM-5 (PCL-5): development and initial psychometric evaluation. J Trauma Stress. 2015;28(6):489–98. https://doi.org/10.1002/jts.22059.CrossRefPubMed

11.

Boeschoten MA, Bakker A, Jongedijk RA, van Minnen A, Elzinga BM, Rademaker AR, et al. Clinician Administered PTSD Scale for DSM-5 - Nederlandstalige versie. Diemen: Arq Psychotrauma Expert Groep; 2014.

12.

Boeschoten MA, Van der Aa N, Bakker A, Ter Heide FJJ, Hoofwijk MC, Jongedijk RA, et al. Development and evaluation of the Dutch clinician-administered PTSD scale for DSM-5 (CAPS-5). Eur J Psychotraumatol. 2018;9(1):1546085. https://doi.org/10.1080/20008198.2018.1546085.CrossRefPubMedPubMedCentral

13.

Bouwmans C, De Jong K, Timman R, Zijlstra-Vlasveld M, Van der Feltz-Cornelis C, Tan SS, et al. Feasibility, reliability and validity of a questionnaire on healthcare consumption and productivity loss in patients with a psychiatric disorder (TiC-P). BMC Health Serv Res. 2013;13(1):217. https://doi.org/10.1186/1472-6963-13-217.CrossRefPubMedPubMedCentral

14.

Chen H, Cohen P, Johnson JG, Kasen S, Sneed JR, Crawford TN. Adolescent personality disorders and conflict with romantic partners during the transition to adulthood. J Personal Disord. 2004;18(6):507–25. https://doi.org/10.1521/pedi.18.6.507.54794.CrossRef

15.

Cohen P, Brown J, Smailes E. Child abuse and neglect and the development of mental disorders in the general population. Dev Psychopathol. 2001;13(4):981–99. https://doi.org/10.1017/S0954579401004126.CrossRefPubMed

16.

Cohen P, Chen H, Kasen S, Johnson JG, Crawford T, Gordon K. Adolescent cluster A personality disorder symptoms, role assumption in the transition to adulthood, and resolution or persistence of symptoms. Dev Psychopathol. 2005a;17(2):549–68.CrossRef

17.

Cohen P, Crawford TN, Johnson JG, Kasen S. The children in the community study of developmental course of personality disorder. J Pers Disord. 2005b;19(5):466–86. https://doi.org/10.1521/pedi.2005.19.5.466.CrossRefPubMed

18.

Cramer V, Torgersen S, Kringlen E. Personality disorders and quality of life. A population study. Compr Psychiatry. 2006;47(3):178–84. https://doi.org/10.1016/j.comppsych.2005.06.002.CrossRefPubMed

19.

Crawford TN, Cohen P, First MB, Skodol AE, Johnson JG, Kasen S. Comorbid Axis I and Axis II disorders in early adolescence: outcomes 20 years later. Arch Gen Psychiatry. 2008;65(6):641–8. https://doi.org/10.1001/archpsyc.65.6.641.CrossRefPubMed

20.

De Jong K, Nugter MA, Polak MG, Wagenborg JE, Spinhoven P, Heiser WJ. The Outcome Questionnaire (OQ-45) in a Dutch population: a cross-cultural validation. Clin Psychol Psychother. 2007;14(4):288–301. https://doi.org/10.1002/cpp.529.CrossRef

21.

De Jongh A, Amann BL, Hofmann A, Farrell D, Lee CW. The status of EMDR therapy in the treatment of posttraumatic stress disorder 30 years after its introduction. J EMDR Pract Res. 2019;13(4):261–9. https://doi.org/10.1891/1933-3196.13.4.261.CrossRef

22.

De Jongh A, Groenland GN, Sanches S, Bongaerts H, Voorendonk EM, Van Minnen A. The impact of brief intensive trauma-focused treatment for PTSD on symptoms of borderline personality disorder. Eur J Psychotraumatol. 2020a;11(1):1721142. https://doi.org/10.1080/20008198.2020.1721142.CrossRefPubMedPubMedCentral

23.

De Jongh A, Ten Broeke E. Handboek EMDR. Seventh ed. Pearson Benelux: Een geprotocolleerde behandelmethode voor de gevolgen van psychotrauma; 2019.

24.

De Jongh A, Ten Broeke E, Farrell D, Maxfield L. Empirically Supported Psychological Treatments: EMDR. In: Beck JG, Sloan DM, editors. Handbook of Traumatic Stress Disorders. Second ed: Oxford Library of Psychology, Oxford University Press, Oxford; 2020b. https://doi.org/10.1093/oxfordhb/9780190088224.013.33.CrossRef

25.

Dolan BM, Warren FM, Menzies D, Norton K. Cost-offset following specialist treatment of severe personality disorders. Psychiatr Bull. 1996;20(7):413–7. https://doi.org/10.1192/pb.20.7.413.CrossRef

26.

European Medicines Agency. (2005). Guideline on data monitoring committees. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-data-monitoring-committees_en.pdf. Accessed 15 Dec 2021.

27.

EuroQol Group. EuroQol-a new facility for the measurement of health-related quality of life. Health Policy. 1990;16(3):199–208. https://doi.org/10.1016/0168-8510(90)90421-9.CrossRef

28.

First MB. Structured clinical interview for the DSM (SCID). Encycl Clin Psychol. 2014:1–6. https://doi.org/10.1002/9781118625392.wbecp351. Accessed 18 Nov 2020.

29.

Goldstein RB, Chou SP, Saha TD, Smith SM, Jung J, Zhang H, et al. The epidemiology of antisocial behavioral syndromes in adulthood: results from the national epidemiologic survey on alcohol and related conditions-III. J Clin Psychiatr. 2017;78(1):90–8. https://doi.org/10.4088/JCP.15m10358.CrossRef

30.

Gratz KL, Roemer L. Multidimensional assessment of emotion regulation and dysregulation: development, factor structure, and initial validation of the difficulties in emotion regulation scale. J Psychopathol Behav Assess. 2004;26(1):41–54. https://doi.org/10.1023/B:JOBA.0000007455.08539.94.CrossRef

31.

Gray MJ, Litz BT, Hsu JL, Lombardo TW. Psychometric properties of the life events checklist. Assessment. 2004;11(4):330–41. https://doi.org/10.1177/1073191104269954.CrossRefPubMed

32.

Guidelines Committee ISTSS. Posttraumatic stress disorder prevention and treatment guidelines methodology and recommendations. Oakbrook Terrace, IL: Author; 2018. Retrieved from http://www.istss.org/treating-trauma/new-istss-prevention-and-treatment-guidelines.aspx

33.

Hafkemeijer LCS, de Jongh A, van der Palen J, Starrenburg A. Eye movement desensitization and reprocessing (EMDR) in patients with a personality disorder. Eur J Psychotraumatol. 2020;11(1):1838777. https://doi.org/10.1080/20008198.2020.1838777.CrossRefPubMedPubMedCentral

34.

Hakkaart-van Roijen, L., van der Linden, N., Bouwmans, C., Kanters, T., & Tan, S. S. (2016). Kostenhandleiding: Methodologie van kostenonderzoek en referentieprijzen voor economische evaluaties in de gezondheidszorg. Institute for Medical Technology Assessment, Erasmus University Rotterdam, the Netherlands.

35.

Hutsebaut J, Feenstra DJ, Kamphuis JH. Development and preliminary psychometric evaluation of a brief self-report questionnaire for the assessment of the DSM–5 level of Personality Functioning Scale: the LPFS Brief Form (LPFS-BF). Pers Disord. 2016;7(2):192.CrossRef

36.

Johnson JG, Cohen P, Brown J, Smailes EM, Bernstein DP. Childhood maltreatment increases risk for personality disorders during early adulthood. Arch Gen Psychiatry. 1999;56(7):600–6. https://doi.org/10.1001/archpsyc.56.7.600.CrossRefPubMed

37.

Johnson JG, Cohen P, Skodol AE, Oldham JM, Kasen S, Brook JS. Personality disorders in adolescence and risk of major mental disorders and suicidality during adulthood. Arch. Gen. Psychiatry. 1999;56(9):805-811.

38.

Johnson JG, Cohen P, Smailes EM, Kasen S, Oldham JM, Skodol AE, et al. Adolescent personality disorders associated with violence and criminal behavior during adolescence and early adulthood. Am J Psychiatr. 2000a;157(9):1406–12. https://doi.org/10.1176/appi.ajp.157.9.1406.CrossRefPubMed

39.

Johnson JG, Cohen P, Smailes EM, Skodol AE, Brown J, Oldham JM. Childhood verbal abuse and risk for personality disorders during adolescence and early adulthood. Compr Psychiatry. 2001;42(1):16–23. https://doi.org/10.1053/comp.2001.19755.CrossRefPubMed

40.

Johnson JG, Smailes EM, Cohen P, Brown J, Bernstein DP. Associations between four types of childhood neglect and personality disorder symptoms during adolescence and early adulthood: findings of a community-based longitudinal study. J Pers Disord. 2000b;14(2):171–87. https://doi.org/10.1521/pedi.2000.14.2.171.CrossRefPubMed

41.

Koons CR, Robins CJ, Tweed JL, Lynch TR, Gonzalez AM, Morse JQ, et al. Efficacy of dialectical behavior therapy in women veterans with borderline personality disorder. Behav Therapy. 2001;32(2):371–90. https://doi.org/10.1016/S0005-7894(01)80009-5.CrossRef

42.

Lambert MJ, Burlingame GM, Umphress V, Hansen NB, Vermeersch DA, Clouse GC, et al. The reliability and validity of the Outcome Questionnaire. Clin Psychol Psychother. 1996;3(4):249–58. https://doi.org/10.1002/(SICI)1099-0879(199612)3:4%3C249::AID-CPP106%3E3.0.CO;2-S.CrossRef

43.

Lamers LM, Stalmeier PF, McDonnell J, Krabbe PF, van Busschbach J. Measuring the quality of life in economic evaluations: the Dutch EQ-5D tariff. Nederlands tijdschrift voor geneeskunde. 2005;149(28):1574–8.PubMed

44.

Lenzenweger MF, Lane MC, Loranger AW, Kessler RC. DSM-IV personality disorders in the National Comorbidity Survey Replication. Biol Psychiatry. 2007;62(6):553–64. https://doi.org/10.1016/j.biopsych.2006.09.019.CrossRefPubMedPubMedCentral

45.

Liu G, Liang KY. Sample size calculations for studies with correlated observations. Biometrics. 1997:937–47. https://doi.org/10.2307/2533554.

46.

Lobbestael J, Leurgans M, Arntz A. Inter-rater reliability of the Structured Clinical Interview for DSM-IV Axis I disorders (SCID I) and Axis II disorders (SCID II). Clin Psychol Psychother. 2011;18(1):75–9. https://doi.org/10.1002/cpp.693.CrossRefPubMed

47.

Maffei C, Fossati A, Agostoni I, Barraco A, Bagnato M, Deborah D, et al. Interrater reliability and internal consistency of the structured clinical interview for DSM-IV axis II personality disorders (SCID-II), version 2.0. J Pers Disord. 1997;11(3):279–84. https://doi.org/10.1521/pedi.1997.11.3.279.CrossRefPubMed

48.

Mavranezouli I, Megnin-Viggars O, Grey N, Bhutani G, Leach J, Daly C, et al. Cost-effectiveness of psychological treatments for post-traumatic stress disorder in adults. PLoS One. 2020;15(4):e0232245. https://doi.org/10.1371/journal.pone.0232245.CrossRefPubMedPubMedCentral

49.

McGuire TM, Lee CW, Drummond PD. Potential of eye movement desensitization and reprocessing therapy in the treatment of post-traumatic stress disorder. Psychol Res Behav Manag. 2014;7:273–83. https://doi.org/10.2147/PRBM.S52268.CrossRefPubMedPubMedCentral

50.

McMurran M, Huband N, Overton E. Non-completion of personality disorder treatments: a systematic review of correlates, consequences, and interventions. Clin Psychol Rev. 2010;30(3):277–87. https://doi.org/10.1016/j.cpr.2009.12.002.CrossRefPubMed

51.

National Collaborating Centre for Mental Health (UK). (2009). Borderline personality disorder: treatment and management. British Psychological Society.

52.

Neumann A, van Lier PA, Gratz KL, Koot HM. Multidimensional assessment of emotion regulation difficulties in adolescents using the difficulties in emotion regulation scale. Assessment. 2010;17(1):138–49. https://doi.org/10.1177/1073191109349579.CrossRefPubMed

53.

Schlier B, Moritz S, Lincoln TM. Measuring fluctuations in paranoia: validity and psychometric properties of brief state versions of the Paranoia Checklist. Psychiatry Res. 2016;241:323–32. https://doi.org/10.1016/j.psychres.2016.05.002.CrossRefPubMed

54.

Schotte CKW, de Doncker DD, Vankerckhoven C, Vertommen H, Cosyns P. Self-report assessment of the DSM-IV personality disorders. Measurement of trait and distress characteristics: the ADP-IV. Psychol Med. 1998;28(5):1179–88. https://doi.org/10.1017/s0033291798007041.CrossRefPubMed

55.

Shapiro F. Eye movement desensitization and reprocessing (EMDR) therapy: basic principles, protocols, and procedures. New York: Guilford Publications; 2018.

56.

Slotema CW, Blom JD, Niemantsverdriet M, Deen M, Sommer IE. Comorbid diagnosis of psychotic disorders in borderline personality disorder: prevalence and influence on outcome. Front Psychiatry. 2018;9:84. https://doi.org/10.3389/fpsyt.2018.00084.CrossRefPubMedPubMedCentral

57.

Slotema CW, van den Berg DP, Driessen A, Wilhelmus B, Franken IH. Feasibility of EMDR for posttraumatic stress disorder in patients with personality disorders: a pilot study. Eur J Psychotraumatol. 2019;10(1):1614822. https://doi.org/10.1080/20008198.2019.1614822.CrossRefPubMedPubMedCentral

58.

Slotema CW, Wilhelmus B, Arends LR, Franken IH. Psychotherapy for posttraumatic stress disorder in patients with borderline personality disorder: a systematic review and meta-analysis of its efficacy and safety. Eur J Psychotraumatol. 2020;11(1):1796188. https://doi.org/10.1080/20008198.2020.1796188.CrossRefPubMedPubMedCentral

59.

Soeteman DI, Roijen LHV, Verheul R, Busschbach JJ. The economic burden of personality disorders in mental health care. J Clin Psychiatry. 2008a;69(2):259–65. https://doi.org/10.1521/pedi.2008.22.3.259.CrossRefPubMed

60.

Soeteman DI, Verheul R, Busschbach JJ. The burden of disease in personality disorders: diagnosis-specific quality of life. J Pers Disord. 2008b;22(3):259–68. https://doi.org/10.1521/pedi.2008.22.3.259.CrossRefPubMed

61.

Taylor S. Outcome predictors for three PTSD treatments: exposure therapy, EMDR, and relaxation training. J Cogn Psychother. 2003;17(2):149–62. https://doi.org/10.1891/jcop.17.2.149.57432.CrossRef

62.

Thombs BD, Bernstein DP, Lobbestael J, Arntz A. A validation study of the Dutch Childhood Trauma Questionnaire-Short Form: factor structure, reliability, and known-groups validity. Child Abuse Neglect. 2009;33(8):518–23. https://doi.org/10.1016/j.chiabu.2009.03.001.CrossRefPubMed

63.

Van Krugten FCW, Busschbach JJV, Versteegh MM, Hakkaart-van Roijen L, Brouwer WBF. The Mental Health Quality of Life Questionnaire (MHQoL): development and first psychometric evaluation of a new measure to assess quality of life in people with mental health problems. Q Life Res. 2021. https://doi.org/10.1007/s11136-021-02935-w.

64.

Van Praag DL, Fardzadeh HE, Covic A, Maas AI, von Steinbüchel N. Preliminary validation of the Dutch version of the Posttraumatic stress disorder checklist for DSM-5 (PCL-5) after traumatic brain injury in a civilian population. PloS One. 2020;15(4):e0231857. https://doi.org/10.1371/journal.pone.0231857.CrossRefPubMedPubMedCentral

65.

Versteegh MM, Vermeulen KM, Evers SM, De Wit GA, Prenger R, Stolk EA. Dutch tariff for the five-level version of EQ-5D. Value Health. 2016;19(4):343–52. https://doi.org/10.1016/j.jval.2016.01.003.CrossRef

66.

Weathers, F. W., Litz, B. T., Herman, D. S., Huska, J. A., & Keane, T. M. (1993). The PTSD Checklist (PCL): Reliability, validity, and diagnostic utility. In annual convention of the international society for traumatic stress studies, San Antonio, TX (Vol. 462).

67.

Weekers LC, Hutsebaut J, Kamphuis JH. The Level of Personality Functioning Scale-Brief Form 2.0: update of a brief instrument for assessing level of personality functioning. Pers Mental Health. 2018;13(1):3–14. https://doi.org/10.1002/pmh.1434.CrossRef

68.

Weertman A, Arntz A, Kerkhofs MLM. Gestructureerd diagnostisch interview voor DSM-IV persoonlijkheidsstoornissen (SCID II) [Structural and Clinical Interview for DSM-IV personality disorders (SCID II)]. Lisse, The Netherlands: Swets Test; 2000.

69.

World Health Organization. Guidelines for the management of conditions that are specifically related to stress. Geneva: Author; 2013. Retrieved from http://apps.who.int/iris/bitstream/handle/10665/85119/9789241505406_eng.pdf

70.

Yen S, Shea MT, Battle CL, Johnson DM, Zlotnick C, Dolan-Sewell R, et al. Traumatic exposure and posttraumatic stress disorder in borderline, schizotypal, avoidant, and obsessive-compulsive personality disorders: fingings from the collaborative longitudinal personality disorders study. J Nervous Mental Dis. 2002;190(8):510–8. https://doi.org/10.1097/00005053-200208000-00003.CrossRef

71.

Zanarini MC, Frankenburg FR, Dubo ED, Sickel AE, Trikha A, Levin A, et al. Axis I comorbidity of borderline personality disorder. Am J Psychiatry. 1998;155(12):1733–9. https://doi.org/10.1176/ajp.155.12.1733.CrossRefPubMed

72.

Zanarini MC, Gunderson JG, Marino MF, Schwartz EO, Frankenburg FR. Childhood experiences of borderline patients. Compr Psychiatry. 1989;30(1):18–25. https://doi.org/10.1016/0010-440X(89)90114-4.CrossRefPubMed

Title: Trauma-focused EMDR for Personality disorders among Outpatients (TEMPO): study protocol for a multi-centre, single-blind, randomized controlled trial
Authors: Simon Hofman
Laurian Hafkemeijer
Ad de Jongh
Annemieke Starrenburg
Karin Slotema
Publication date: 01-12-2022
Publisher: BioMed Central
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-06082-6

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Trauma-focused EMDR for Personality disorders among Outpatients (TEMPO): study protocol for a multi-centre, single-blind, randomized controlled trial

Abstract

Background

Method

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Method

Discussion

Trial registration

Please log in to get access to this content

Other articles of this Issue 1/2022

The ALLEGRO trial: a placebo controlled randomised trial of intravenous lidocaine in accelerating gastrointestinal recovery after colorectal surgery

OPAL: a randomised, placebo-controlled trial of opioid analgesia for the reduction of pain severity in people with acute spinal pain—a statistical analysis plan

Correction: Interdisciplinary and cross-sectoral perioperative care model in cardiac surgery: implementation in the setting of minimally invasive heart valve surgery (INCREASE)—study protocol for a randomized controlled trial

An international, stepped wedge, cluster-randomized trial investigating the 0/1-h algorithm in suspected acute coronary syndrome in Asia: the rational of the DROP-Asian ACS study

Postpartum haemorrhage in anaemic women: assessing outcome measures for clinical trials

Effect of m-health-based core stability exercise combined with self-compassion training for patients with non-specific chronic low back pain: study protocol for a randomized controlled trial