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Open Access 01-12-2015 | Study protocol

Internet-based cognitive behavioural therapy (iCBT) for posttraumatic stress disorder versus waitlist control: study protocol for a randomised controlled trial

Authors: Adrian R. Allen, Jill M. Newby, Jessica Smith, Gavin Andrews

Published in: Trials | Issue 1/2015

Abstract

Background

This randomised controlled trial (RCT) with two parallel arms will evaluate the efficacy of an internet-delivered six-lesson 10-week cognitive behavioural therapy (iCBT) intervention for posttraumatic stress disorder (PTSD). It will also investigate the association between changes in PTSD symptoms, intolerance of uncertainty (IU) and emotion regulation.

Methods/Design

Patients with PTSD will be recruited via the research arm of a not-for-profit clinical and research unit in Australia and randomised to a treatment group or waitlist control group. The minimum sample size for each group (alpha 0.05, power 0.80 for a g of 0.47) was identified as 72, but 10 % more will be recruited to hedge against expected attrition. PTSD diagnosis will be determined using the PTSD module from the Mini International Neuropsychiatric Interview version 5.0.0. The PTSD Checklist – Civilian version (PCL-C) will be used to measure PTSD symptoms (the primary outcome measure), with the Intolerance of Uncertainty Scale 12-item version (IUS-12) and the Emotion Regulation Questionnaire (ERQ) used to measure intolerance of uncertainty and emotion regulation, respectively. The PCL-C will be administered to the treatment group before each lesson of the PTSD program and at 3-month follow-up. The IUS-12 and ERQ will be administered before lessons 1 and 4, at post-treatment and at 3-month follow-up. The waitlist control group will complete these measures at week 1, week 5 and week 11 of the waitlist period. PTSD program efficacy will be determined using intent-to-treat mixed models. Maintenance of gains will be assessed at 3-month follow-up. Mediation analyses using PROCESS will be used to examine the association between change in PTSD symptoms over treatment and change in each of IU and emotion regulation ability in separate analyses.

Discussion

The current RCT seeks to replicate previous efficacy findings of iCBT for PTSD in a formally assessed PTSD sample from the general population. Findings may point to future lines of enquiry for the role of IU and emotion regulation in the mechanism of PTSD symptom change during CBT.

Trial registration

Australian New Zealand Clinical Trials Registry: ACTRN12614001213639, registered 18 November 2014. This trial protocol is written in compliance with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines.

American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 5th ed. Arlington: American Psychiatric Association; 2013.

Kessler RC, Berglund P, Demler O, Jin R, Merikangas KR, Walters EE. Lifetime prevalence and age-of-onset distributions of DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005;62:593–602. doi:10.1001/archpsyc.62.6.593.CrossRefPubMed

McEvoy PM, Grove R, Slade T. Epidemiology of anxiety disorders in the Australian general population: findings of the 2007 Australian National Survey of Mental Health and Wellbeing. Aust N Z J Psychiatry. 2011;45:957–67. doi:10.3109/00048674.2011.624083.CrossRefPubMed

Slade T, Watson D. The structure of common DSM-IV and ICD-10 mental disorders in the Australian general population. Psychol Med. 2006;36:1593–600. doi:10.1017/s0033291706008452.CrossRefPubMed

Chapman C, Mills K, Slade T, McFarlane AC, Bryant R, Creamer M, et al. Remission from post-traumatic stress disorder in the general population. Psychol Med. 2012;42:1695–703.CrossRefPubMed

Sareen J, Cox BJ, Stein MB, Afifi TO, Fleet C, Asmundson GJG. Physical and mental comorbidity, disability, and suicidal behavior associated with posttraumatic stress disorder in a large community sample. Psychosom Med. 2007;69:242–8. doi:10.1097/PSY.0b013e31803146d8.CrossRefPubMed

Scott KM, Koenen KC, Aguilar-Gaxiola S, Alonso J, Angermeyer MC, Benjet C, et al. Associations between lifetime traumatic events and subsequent chronic physical conditions: a cross-national, cross-sectional study. PLoS One. 2013;8:e80573. doi:10.1371/journal.pone.0080573.CrossRefPubMedPubMedCentral

Zayfert C, Becker CB, Unger DL, Shearer DK. Comorbid anxiety disorders in civilians seeking treatment for posttraumatic stress disorder. J Trauma Stress. 2002;15:31–8. doi:10.1023/a:1014379127240.CrossRefPubMed

Panagioti M, Gooding P, Tarrier N. Post-traumatic stress disorder and suicidal behavior: a narrative review. Clin Psychol Rev. 2009;29:471–82. doi:10.1016/j.cpr.2009.05.001.CrossRefPubMed

10.

NICE. Post-traumatic stress disorder (PTSD): the management of PTSD in adults and children in primary and secondary care. NICE clinical guideline 26. 2005. Available at http://guidance.nice.org.uk/CG26.

11.

Australian Centre for Posttraumatic Mental Health. Australian guidelines for the treatment of acute stress disorder and posttraumatic stress disorder. Melbourne: ACPMH; 2013.

12.

Harvey AG, Bryant RA, Tarrier N. Cognitive behaviour therapy for posttraumatic stress disorder. Clin Psychol Rev. 2003;23:501–22.CrossRefPubMed

13.

Mendes DD, Marcelo Feijó M, Paula V, Cristiane de Medeiros P, Jair de Jesus M. A systematic review on the effectiveness of cognitive behavioral therapy for posttraumatic stress disorder. Int J Psychiatry Med. 2008;38(3):241.CrossRefPubMed

14.

Ponniah K, Hollon SD. Empirically supported psychological treatments for adult acute stress disorder and posttraumatic stress disorder: a review. Depress Anxiety. 2009;26:1086–109. doi:10.1002/da.20635.CrossRefPubMed

15.

Roberts NP, Kitchiner NJ, Kenardy J, Bisson JI. Systematic review and meta-analysis of multiple-session early interventions following traumatic events. Am J Psychiatry. 2009;166:293–301. doi:10.1176/appi.ajp.2008.08040590.CrossRefPubMed

16.

Wang PS, Lane M, Olfson M, Pincus HA, Wells KB, Kessler RC. Twelve-month use of mental health services in the United States: results from the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005;62:629–40. doi:10.1001/archpsyc.62.6.629.CrossRefPubMed

17.

McLean CP, Foa EB. Prolonged exposure therapy for post-traumatic stress disorder: a review of evidence and dissemination. Expert Rev Neurother. 2011;11:1151–63. doi:10.1586/ern.11.94.CrossRefPubMed

18.

Litz BT, Engel CC, Bryant RA, Papa A. A randomized, controlled proof-of-concept trial of an Internet-based, therapist-assisted self-management treatment for posttraumatic stress disorder. Am J Psychiatry. 2007;164:1676–83. doi:10.1176/appi.ajp.2007.06122057.CrossRefPubMed

19.

Lange A, Rietdijk D, Hudcovicova M, van de Ven JP, Schrieken B, Emmelkamp PM. Interapy: a controlled randomized trial of the standardized treatment of posttraumatic stress through the internet. J Consult Clin Psychol. 2003;71:901–9. doi:10.1037/0022-006x.71.5.901.CrossRefPubMed

20.

Spence J, Titov N, Dear BF, Johnston L, Solley K, Lorian C, et al. Randomized controlled trial of Internet‐delivered cognitive behavioral therapy for posttraumatic stress disorder. Depress Anxiety. 2011;28:541–50.CrossRefPubMed

21.

Klein B, Mitchell J, Abbott J, Shandley K, Austin D, Gilson K, et al. A therapist-assisted cognitive behavior therapy internet intervention for posttraumatic stress disorder: pre-, post- and 3-month follow-up results from an open trial. J Anxiety Disord. 2010;24:635–44. doi:10.1016/j.janxdis.2010.04.005.CrossRefPubMed

22.

Hirai M, Clum GA. An Internet-based self-change program for traumatic event related fear, distress, and maladaptive coping. J Trauma Stress. 2005;18:631–6. doi:10.1002/jts.20071.CrossRefPubMed

23.

Knaevelsrud C, Brand J, Lange A, Ruwaard J, Wagner B. Web-based psychotherapy for posttraumatic stress disorder in war-traumatized Arab patients: randomized controlled trial. J Med Internet Res. 2015;17:e71. doi:10.2196/jmir.3582.CrossRefPubMedPubMedCentral

24.

McEvoy PM, Mahoney AE. To be sure, to be sure: intolerance of uncertainty mediates symptoms of various anxiety disorders and depression. Behav Ther. 2012;43:533–45. doi:10.1016/j.beth.2011.02.007.CrossRefPubMed

25.

McEvoy PM, Mahoney AE. Achieving certainty about the structure of intolerance of uncertainty in a treatment-seeking sample with anxiety and depression. J Anxiety Disord. 2011;25:112–22. doi:10.1016/j.janxdis.2010.08.010.CrossRefPubMed

26.

Einstein DA. Extension of the transdiagnostic model to focus on intolerance of uncertainty: a review of the literature and implications for treatment. Clin Psychol. 2014;21:280–300. doi:10.1111/cpsp.12077.

27.

Buhr K, Dugas MJ. The role of fear of anxiety and intolerance of uncertainty in worry: an experimental manipulation. Behav Res Ther. 2009;47:215–23. doi:10.1016/j.brat.2008.12.004.CrossRefPubMed

28.

Boswell JF, Thompson-Hollands J, Farchione TJ, Barlow DH. Intolerance of uncertainty: a common factor in the treatment of emotional disorders. J Clin Psychol. 2013;69:630–45. doi:10.1002/jclp.21965.CrossRefPubMed

29.

Fetzner MG, Horswill SC, Boelen PA, Carleton RN. Intolerance of uncertainty and PTSD symptoms: exploring the construct relationship in a community sample with a heterogeneous trauma history. Cogn Ther Res. 2013;37:725–34.CrossRef

30.

Bryant RA, Mastrodomenico J, Hopwood S, Kenny L, Cahill C, Kandris E, et al. Augmenting cognitive behaviour therapy for post-traumatic stress disorder with emotion tolerance training: a randomized controlled trial. Psychol Med. 2013;43:2153–60. doi:10.1017/s0033291713000068.CrossRefPubMed

31.

Cloitre M, Stovall-McClough KC, Nooner K, Zorbas P, Cherry S, Jackson CL, et al. Treatment for PTSD related to childhood abuse: a randomized controlled trial. Am J Psychiatry. 2010;167:915–24. doi:10.1176/appi.ajp.2010.09081247.CrossRefPubMed

32.

Jerud AB, Zoellner LA, Pruitt LD, Feeny NC. Changes in emotion regulation in adults with and without a history of childhood abuse following posttraumatic stress disorder treatment. J Consult Clin Psychol. 2014;82:721–30. doi:10.1037/a0036520.CrossRefPubMedPubMedCentral

33.

Wisco BE, Sloan DM, Marx BP. Cognitive emotion regulation and written exposure therapy for posttraumatic stress disorder. Clin Psychol Sci. 2013;1:435–42. doi:10.1177/2167702613486630.CrossRefPubMedPubMedCentral

34.

Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586. doi:10.1136/bmj.e7586.CrossRefPubMedPubMedCentral

35.

Schulz KF, Altman DG, Moher D. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMC Med. 2010;8:18. doi:10.1186/1741-7015-8-18.CrossRefPubMedPubMedCentral

36.

Bisson J, Andrew M. Psychological treatment of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2007;3:1–46.

37.

Foa EB, Keane TM, Friedman MJ, Cohen JA, editors. Effective treatments for PTSD: practice guidelines from the International Society for Traumatic Stress Studies. 2nd ed. New York: Guilford Press; 2008.

38.

Resick PA, Galovski TE, O'Brien Uhlmansiek M, Scher CD, Clum GA, Young-Xu Y. A randomized clinical trial to dismantle components of cognitive processing therapy for posttraumatic stress disorder in female victims of interpersonal violence. J Consult Clin Psychol. 2008;76:243–58. doi:10.1037/0022-006x.76.2.243.CrossRefPubMedPubMedCentral

39.

Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, et al. 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. quiz 4–57.PubMed

40.

Weathers FW, Litz BT, Herman DS, Huska JA, Keane TM, editors. The PTSD Checklist (PCL): reliability, validity, and diagnostic utility. Proceedings in the 9^th Annual Convention of the International Society for Traumatic Stress Studies; 1993 Oct 25: San Antonio, Texas.

41.

Weathers FW, Litz BT, Keane TM, Palmieri PA, Marx BP, Schnurr PP. The PTSD Checklist for DSM-5 (PCL-5). Scale available from the National Center for PTSD at www.ptsd.va.gov. (2013).

42.

Kroenke K, Spitzer RL, Williams JB. The Phq‐9. J Gen Intern Med. 2001;16:606–13.CrossRefPubMedPubMedCentral

43.

Newby JM, Mackenzie A, Williams AD, McIntyre K, Watts S, Wong N, et al. Internet cognitive behavioural therapy for mixed anxiety and depression: a randomized controlled trial and evidence of effectiveness in primary care. Psychol Med. 2013;43:2635–48. doi:10.1017/s0033291713000111.CrossRefPubMed

44.

Williams AD, Blackwell SE, Mackenzie A, Holmes EA, Andrews G. Combining imagination and reason in the treatment of depression: a randomized controlled trial of internet-based cognitive-bias modification and internet-CBT for depression. J Consult Clin Psychol. 2013;81:793–9. doi:10.1037/a0033247.CrossRefPubMedPubMedCentral

45.

Kessler RC, Andrews G, Colpe LJ, Hiripi E, Mroczek DK, Normand SL, et al. Short screening scales to monitor population prevalences and trends in non-specific psychological distress. Psychol Med. 2002;32:959–76.CrossRefPubMed

46.

Sunderland M, Wong N, Hilvert-Bruce Z, Andrews G. Investigating trajectories of change in psychological distress amongst patients with depression and generalised anxiety disorder treated with internet cognitive behavioural therapy. Behav Res Ther. 2012;50:374–80. doi:10.1016/j.brat.2012.03.005.CrossRefPubMed

47.

Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006;166:1092–7.CrossRefPubMed

48.

Löwe B, Spitzer RL, Williams JBW, Mussell M, Schellberg D, Kroenke K. Depression, anxiety and somatization in primary care: syndrome overlap and functional impairment. Gen Hosp Psychiatry. 2008;30:191–9. doi:10.1016/j.genhosppsych.2008.01.001.CrossRefPubMed

49.

Carleton RN, Norton MPJ, Asmundson GJ. Fearing the unknown: a short version of the Intolerance of Uncertainty Scale. J Anxiety Disord. 2007;21:105–17.CrossRefPubMed

50.

Gross JJ, John OP. Mapping the domain of expressivity: multimethod evidence for a hierarchical model. J Pers Soc Psychol. 1998;74:170–91.CrossRefPubMed

51.

Gross JJ, John OP. Individual differences in two emotion regulation processes: implications for affect, relationships, and well-being. J Pers Soc Psychol. 2003;85:348–62.CrossRefPubMed

52.

Andrews G. National Mental Health Interview. Sydney: WHO Collaborating Centre for Mental Health and Substance AbuseSydney; 1997.

53.

Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000;31:73–86.CrossRefPubMed

54.

Blake DD, Weathers FW, Nagy LM, Kaloupek DG, Gusman FD, Charney DS, et al. The development of a Clinician-Administered PTSD Scale. J Trauma Stress. 1995;8:75–90.CrossRefPubMed

55.

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

56.

Weathers FW, Blake DD, Schnurr PP, Kaloupek DG, Marx BP, Keane TM. The Life Events Checklist for DSM-5 (LEC-5). 2013. Instrument available from the National Center for PTSD at www.ptsd.va.gov.

57.

Beck AT, Steer RA, Brown GK. Manual for the Beck Depression Inventory (second edition). San Antonio, TX: Psychological Corporation; 1996.

58.

Carlson EB, Putnam FW, Ross CA, Torem M, Coons P, Dill DL, et al. Validity of the Dissociative Experiences Scale in screening for multiple personality disorder: a multicenter study. Am J Psychiatry. 1993;150:1030–6. doi:10.1176/ajp.150.7.1030.CrossRefPubMed

59.

Dubester KA, Braun BG. Psychometric properties of the Dissociative Experiences Scale. J Nerv Ment Dis. 1995;183:231–5.CrossRefPubMed

60.

Jarrett RB, Vittengl JR, Clark LA, Thase ME. Skills of Cognitive Therapy (SoCT): a new measure of patients' comprehension and use. Psychol Assess. 2011;23:578–86. doi:10.1037/a0022485.CrossRefPubMedPubMedCentral

61.

Moran P, Leese M, Lee T, Walters P, Thornicroft G, Mann A. Standardised Assessment of Personality – Abbreviated Scale (SAPAS): preliminary validation of a brief screen for personality disorder. Br J Psychiatry. 2003;183:228–32. doi:10.1192/bjp.183.3.228.CrossRefPubMed

62.

Andrews G, Cuijpers P, Craske MG, McEvoy P, Titov N. Computer therapy for the anxiety and depressive disorders is effective, acceptable and practical health care: a meta-analysis. PLoS One. 2010;5:e13196. doi:10.1371/journal.pone.0013196.CrossRefPubMedPubMedCentral

63.

Gueorguieva R, Krystal JH. Move over ANOVA: progress in analyzing repeated-measures data and its reflection in papers published in the Archives of General Psychiatry. Arch Gen Psychiatry. 2004;61:310–7. doi:10.1001/archpsyc.61.3.310.CrossRefPubMed

64.

Salim A, Mackinnon A, Christensen H, Griffiths K. Comparison of data analysis strategies for intent-to-treat analysis in pre-test-post-test designs with substantial dropout rates. Psychiatry Res. 2008;160:335–45. doi:10.1016/j.psychres.2007.08.005.CrossRefPubMed

65.

Hayes AF. Introduction to mediation, moderation, and conditional process analysis: A regression-based approach. New York: Guilford Press; 2013.

66.

Baron RM, Kenny DA. The moderator-mediator variable distinction in social psychological research: conceptual, strategic, and statistical considerations. J Pers Soc Psychol. 1986;51:1173–82.CrossRefPubMed

67.

Hayes AF. Beyond Baron and Kenny: Statistical mediation analysis in the new millennium. Commun Monogr. 2009;76:408–20.CrossRef

68.

Preacher KJ, Hayes AF. Asymptotic and resampling strategies for assessing and comparing indirect effects in multiple mediator models. Behav Res Methods. 2008;40:879–91.CrossRefPubMed

69.

Williams J, Mackinnon D. Resampling and distribution of the product methods for testing indirect effects in complex models. Struct Equ Model. 2008;15:23–51.CrossRef

70.

Chard KM. An evaluation of cognitive processing therapy for the treatment of posttraumatic stress disorder related to childhood sexual abuse. J Consult Clin Psychol. 2005;73:965–71. doi:10.1037/0022-006x.73.5.965.CrossRefPubMed

71.

McDonagh A, Friedman M, McHugo G, Ford J, Sengupta A, Mueser K, et al. Randomized trial of cognitive-behavioral therapy for chronic posttraumatic stress disorder in adult female survivors of childhood sexual abuse. J Consult Clin Psychol. 2005;73:515–24. doi:10.1037/0022-006x.73.3.515.CrossRefPubMed

Title: Internet-based cognitive behavioural therapy (iCBT) for posttraumatic stress disorder versus waitlist control: study protocol for a randomised controlled trial
Authors: Adrian R. Allen
Jill M. Newby
Jessica Smith
Gavin Andrews
Publication date: 01-12-2015
Publisher: BioMed Central
Published in: Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-015-1059-5

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Internet-based cognitive behavioural therapy (iCBT) for posttraumatic stress disorder versus waitlist control: study protocol for a randomised controlled trial

Abstract

Background

Methods/Design

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods/Design

Discussion

Trial registration

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