An Internet-Based Cognitive Behavioral Program for Adolescents With Anxiety: Pilot Randomized Controlled Trial

Kathleen O'Connor, Alexa Bagnell, Patrick McGrath, Lori Wozney, Ashley Radomski, Rhonda J Rosychuk, Sarah Curtis, Mona Jabbour, Eleanor Fitzpatrick, David W Johnson, Arto Ohinmaa, Anthony Joyce, Amanda Newton, Kathleen O'Connor, Alexa Bagnell, Patrick McGrath, Lori Wozney, Ashley Radomski, Rhonda J Rosychuk, Sarah Curtis, Mona Jabbour, Eleanor Fitzpatrick, David W Johnson, Arto Ohinmaa, Anthony Joyce, Amanda Newton

Abstract

Background: Internet-based cognitive behavioral therapy (ICBT) is a treatment approach recently developed and studied to provide frontline treatment to adolescents with anxiety disorders.

Objective: This study aimed to pilot procedures and obtain data on methodological processes and intervention satisfaction to determine the feasibility of a definitive randomized controlled trial (RCT) to test the effectiveness of a self-managed ICBT program, Breathe (Being Real, Easing Anxiety: Tools Helping Electronically), for adolescents with anxiety concerns.

Methods: This study employed a two-arm, multisite, pilot RCT. Adolescents aged 13 to 17 years with a self-identified anxiety concern were recruited online from health care settings and school-based mental health care services across Canada between April 2014 and May 2016. We compared 8 weeks of ICBT with ad hoc telephone and email support (Breathe experimental group) to access to a static webpage listing anxiety resources (control group). The primary outcome was the change in self-reported anxiety from baseline to 8 weeks (posttreatment), which was used to determine the sample size for a definitive RCT. Secondary outcomes were recruitment and retention rates, a minimal clinically important difference (MCID) for the primary outcome, intervention acceptability and satisfaction, use of cointerventions, and health care resource use, including a cost-consequence analysis.

Results: Of the 588 adolescents screened, 94 were eligible and enrolled in the study (49 adolescents were allocated to Breathe and 45 were allocated to the control group). Analysis was based on 74% (70/94) of adolescents who completed baseline measures and progressed through the study. Enrolled adolescents were, on average, 15.3 years old (SD 1.2) and female (63/70, 90%). Retention rates at 8 weeks were 28% (13/46; Breathe group) and 58% (24/43; control group). Overall, 39% (14/36) of adolescents provided feedback on completion of the Breathe program. Adolescents' scores on a satisfaction survey indicated a moderate level of satisfaction. All but one adolescent indicated that Breathe was easy to use and they understood all the material presented. The most frequent barrier identified for program completion was difficulty in completing exposure activities. The power analysis indicated that 177 adolescents per group would be needed to detect a medium effect size (d=0.3) between groups in a definitive trial. Data for calculating an MCID or conducting a cost-consequence analysis were insufficient due to a low response rate at 8 weeks.

Conclusions: Adolescents were moderately satisfied with Breathe. However, program adjustments will be needed to address attrition and reduce perceived barriers to completing key aspects of the program. A definitive RCT to evaluate the effectiveness of the program is feasible if protocol adjustments are made to improve recruitment and retention to ensure timely study completion and increase the completeness of the data at each outcome measurement time point.

Trial registration: ClinicalTrials.gov NCT02059226; https://ichgcp.net/clinical-trials-registry/NCT02059226.

Keywords: adolescents; anxiety; cognitive behavioral therapy; internet; pilot; randomized controlled trial.

Conflict of interest statement

Conflicts of Interest: During this work, AN held a CIHR New Investigator Award and RR held a Health Scholar award from Alberta Innovates—Health Solutions. PM holds a Tier I Canada Research Chair. The other authors have no conflicts to declare.

©Kathleen O'Connor, Alexa Bagnell, Patrick McGrath, Lori Wozney, Ashley Radomski, Rhonda J Rosychuk, Sarah Curtis, Mona Jabbour, Eleanor Fitzpatrick, David W Johnson, Arto Ohinmaa, Anthony Joyce, Amanda Newton. Originally published in JMIR Mental Health (http://mental.jmir.org), 24.07.2020.

Figures

Figure 1
Figure 1
Being Real, Easing Anxiety: Tools Helping Electronically check-in activity.
Figure 2
Figure 2
Example of adolescent-provided personal information for module tailoring.
Figure 3
Figure 3
Consolidated Standards of Reporting Trials diagram describing flow of participants through the study. ASQ: Ask Suicide-Screening Questions; CBT: cognitive behavioral therapy; SCARED: Screen for Child Anxiety-Related Emotional Disorders.
Figure 4
Figure 4
Percentage of adolescents who completed each Being Real, Easing Anxiety: Tools Helping Electronically module.

References

    1. Merikangas KR, He J, Burstein M, Swanson SA, Avenevoli S, Cui L, Benjet C, Georgiades K, Swendsen J. Lifetime prevalence of mental disorders in US adolescents: results from the national comorbidity survey replication-adolescent supplement (NCS-A) J Am Acad Child Adolesc Psychiatry. 2010 Oct;49(10):980–9. doi: 10.1016/j.jaac.2010.05.017.
    1. Whiteford HA, Degenhardt L, Rehm J, Baxter AJ, Ferrari AJ, Erskine HE, Charlson FJ, Norman RE, Flaxman AD, Johns N, Burstein R, Murray CJ, Vos T. Global burden of disease attributable to mental and substance use disorders: findings from the global burden of disease study 2010. Lancet. 2013 Nov 9;382(9904):1575–86. doi: 10.1016/S0140-6736(13)61611-6.
    1. American Psychiatric Association . Diagnostic and Statistical Manual of Mental Disorders: DSM-5. Fifth Edition. Washington, DC: American Psychiatric Publishing; 2013.
    1. Connolly SD, Bernstein GA, Work Group on Quality Issues Practice parameter for the assessment and treatment of children and adolescents with anxiety disorders. J Am Acad Child Adolesc Psychiatry. 2007 Feb;46(2):267–83. doi: 10.1097/01.chi.0000246070.23695.06.
    1. Burstein M, Beesdo-Baum K, He J, Merikangas KR. Threshold and subthreshold generalized anxiety disorder among US adolescents: prevalence, sociodemographic, and clinical characteristics. Psychol Med. 2014 Aug;44(11):2351–62. doi: 10.1017/S0033291713002997.
    1. Cartwright-Hatton S, McNicol K, Doubleday E. Anxiety in a neglected population: prevalence of anxiety disorders in pre-adolescent children. Clin Psychol Rev. 2006 Nov;26(7):817–33. doi: 10.1016/j.cpr.2005.12.002.
    1. Seligman LD, Ollendick TH. Cognitive-behavioral therapy for anxiety disorders in youth. Child Adolesc Psychiatr Clin N Am. 2011 Apr;20(2):217–38. doi: 10.1016/j.chc.2011.01.003.
    1. James AC, James G, Cowdrey FA, Soler A, Choke A. Cognitive behavioural therapy for anxiety disorders in children and adolescents. Cochrane Database Syst Rev. 2013 Jun 3;(6):CD004690. doi: 10.1002/14651858.CD004690.pub3.
    1. Ginsburg G, Becker-Haimes E, Keeton C, Kendall P, Iyengar S, Sakolsky D, Albano AM, Peris T, Compton SN, Piacentini J. Results from the Child/Adolescent Anxiety Multimodal Extended Long-Term Study (CAMELS): Primary Anxiety Outcomes. J Am Acad Child Adolesc Psychiatry. 2018 Jul;57(7):471–80. doi: 10.1016/j.jaac.2018.03.017.
    1. Andersson G, Carlbring P, Berger T, Almlöv J, Cuijpers P. What makes Internet therapy work? Cogn Behav Ther. 2009;38(Suppl 1):55–60. doi: 10.1080/16506070902916400.
    1. Silfvernagel K, Gren-Landell M, Emanuelsson M, Carlbring P, Andersson G. Individually tailored internet-based cognitive behavior therapy for adolescents with anxiety disorders: a pilot effectiveness study. Internet Interv. 2015 Sep 26;2(3):297–302. doi: 10.1016/j.invent.2015.07.002.
    1. Spence SH, Donovan CL, March S, Gamble A, Anderson RE, Prosser S, Kenardy J. A randomized controlled trial of online versus clinic-based CBT for adolescent anxiety. J Consult Clin Psychol. 2011 Oct;79(5):629–42. doi: 10.1037/a0024512.
    1. Tillfors M, Andersson G, Ekselius L, Furmark T, Lewenhaupt S, Karlsson A, Carlbring P. A randomized trial of Internet-delivered treatment for social anxiety disorder in high school students. Cogn Behav Ther. 2011;40(2):147–57. doi: 10.1080/16506073.2011.555486.
    1. Stjerneklar S, Hougaard E, McLellan LF, Thastum M. A randomized controlled trial examining the efficacy of an internet-based cognitive behavioral therapy program for adolescents with anxiety disorders. PLoS One. 2019;14(9):e0222485. doi: 10.1371/journal.pone.0222485.
    1. March S, Spence SH, Donovan CL, Kenardy JA. Large-scale dissemination of internet-based cognitive behavioral therapy for youth anxiety: feasibility and acceptability study. J Med Internet Res. 2018 Jul 4;20(7):e234. doi: 10.2196/jmir.9211.
    1. Stjerneklar S, Hougaard E, Nielsen AD, Gaardsvig MM, Thastum M. Internet-based cognitive behavioral therapy for adolescents with anxiety disorders: a feasibility study. Internet Interv. 2018 Mar;11:30–40. doi: 10.1016/j.invent.2018.01.001.
    1. Gren-Landell M, Björklind A, Tillfors M, Furmark T, Svedin CG, Andersson G. Evaluation of the psychometric properties of a modified version of the social phobia screening questionnaire for use in adolescents. Child Adolesc Psychiatry Ment Health. 2009 Nov 11;3(1):36. doi: 10.1186/1753-2000-3-36.
    1. Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988 Dec;56(6):893–7. doi: 10.1037//0022-006x.56.6.893.
    1. Svanborg P, Asberg M. A new self-rating scale for depression and anxiety states based on the Comprehensive Psychopathological Rating Scale. Acta Psychiatr Scand. 1994 Jan;89(1):21–8. doi: 10.1111/j.1600-0447.1994.tb01480.x.
    1. Vigerland S, Lenhard F, Bonnert M, Lalouni M, Hedman E, Ahlen J, Olén O, Serlachius E, Ljótsson B. Internet-delivered cognitive behavior therapy for children and adolescents: a systematic review and meta-analysis. Clin Psychol Rev. 2016 Dec;50:1–10. doi: 10.1016/j.cpr.2016.09.005.
    1. Newton AS, Wozney L, Bagnell A, Fitzpatrick E, Curtis S, Jabbour M, Johnson D, Rosychuk RJ, Young M, Ohinmaa A, Joyce A, McGrath P. Increasing access to mental health care with Breathe, an internet-based program for anxious adolescents: study protocol for a pilot randomized controlled trial. JMIR Res Protoc. 2016 Jan 29;5(1):e18. doi: 10.2196/resprot.4428.
    1. Rocket Science Group. [2020-05-13]. Mailchimp .
    1. myStudies. [2020-05-13]. myStudies: A Connec Service .
    1. Wozney L, McGrath PJ, Newton A, Huguet A, Franklin M, Perri K, Leuschen K, Toombs E, Lingley-Pottie P. Usability, learnability and performance evaluation of Intelligent Research and Intervention Software: a delivery platform for ehealth interventions. Health Informatics J. 2016 Sep;22(3):730–43. doi: 10.1177/1460458215586803.
    1. Birmaher B, Brent DA, Chiappetta L, Bridge J, Monga S, Baugher M. Psychometric properties of the Screen for Child Anxiety Related Emotional Disorders (SCARED): a replication study. J Am Acad Child Adolesc Psychiatry. 1999 Oct;38(10):1230–6. doi: 10.1097/00004583-199910000-00011.
    1. Horowitz LM, Bridge JA, Teach SJ, Ballard E, Klima J, Rosenstein DL, Wharff EA, Ginnis K, Cannon E, Joshi P, Pao M. Ask suicide-screening questions (ASQ): a brief instrument for the pediatric emergency department. Arch Pediatr Adolesc Med. 2012 Dec;166(12):1170–6. doi: 10.1001/archpediatrics.2012.1276.
    1. Zelen M. The randomization and stratification of patients to clinical trials. J Chronic Dis. 1974 Sep;27(7-8):365–75. doi: 10.1016/0021-9681(74)90015-0.
    1. Wozney L, Baxter P, Newton AS. Usability evaluation with mental health professionals and young people to develop an internet-based cognitive-behaviour therapy program for adolescents with anxiety disorders. BMC Pediatr. 2015 Dec 16;15:213. doi: 10.1186/s12887-015-0534-1.
    1. Kelders SM, Kok RN, Ossebaard HC, van Gemert-Pijnen JE. Persuasive system design does matter: a systematic review of adherence to web-based interventions. J Med Internet Res. 2012 Nov 14;14(6):e152. doi: 10.2196/jmir.2104.
    1. Hale III WW, Raaijmakers QA, van Hoof A, Meeus WH. Improving screening cut-off scores for DSM-5 adolescent anxiety disorder symptom dimensions with the Screen for Child Anxiety Related Emotional Disorders. Psychiatry J. 2014;2014:517527. doi: 10.1155/2014/517527. doi: 10.1155/2014/517527.
    1. Desousa DA, Salum GA, Isolan LR, Manfro GG. Sensitivity and specificity of the Screen for Child Anxiety Related Emotional Disorders (SCARED): a community-based study. Child Psychiatry Hum Dev. 2013 Jun;44(3):391–9. doi: 10.1007/s10578-012-0333-y.
    1. Crocetti E, Hale WW, Fermani A, Raaijmakers Q, Meeus W. Psychometric properties of the screen for child anxiety related emotional disorders (SCARED) in the general Italian adolescent population: a validation and a comparison between Italy and the Netherlands. J Anxiety Disord. 2009 Aug;23(6):824–9. doi: 10.1016/j.janxdis.2009.04.003.
    1. March JS, Parker JD, Sullivan K, Stallings P, Conners CK. The Multidimensional Anxiety Scale for Children (MASC): factor structure, reliability, and validity. J Am Acad Child Adolesc Psychiatry. 1997 Apr;36(4):554–65. doi: 10.1097/00004583-199704000-00019.
    1. March J, Parker JD. The Multidimensional Anxiety Scale for Children (MASC) In: Maruish ME, editor. The Use of Psychological Testing for Treatment Planning and Outcomes Assessment: Volume 1: General Considerations. New York, USA: Routledge; 2004. pp. 39–62.
    1. Dierker LC, Albano AM, Clarke GN, Heimberg RG, Kendall PC, Merikangas KR, Lewinsohn PM, Offord DR, Kessler R, Kupfer DJ. Screening for anxiety and depression in early adolescence. J Am Acad Child Adolesc Psychiatry. 2001 Aug;40(8):929–36. doi: 10.1097/00004583-200108000-00015.
    1. Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials. 1989 Dec;10(4):407–15. doi: 10.1016/0197-2456(89)90005-6.
    1. Crosby RD, Kolotkin RL, Williams GR. Defining clinically meaningful change in health-related quality of life. J Clin Epidemiol. 2003 May;56(5):395–407. doi: 10.1016/s0895-4356(03)00044-1.
    1. Arain M, Campbell MJ, Cooper CL, Lancaster GA. What is a pilot or feasibility study? A review of current practice and editorial policy. BMC Med Res Methodol. 2010 Jul 16;10:67. doi: 10.1186/1471-2288-10-67.
    1. Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004 May;10(2):307–12. doi: 10.1111/j..2002.384.doc.x.
    1. Browne RH. On the use of a pilot sample for sample size determination. Stat Med. 1995 Sep 15;14(17):1933–40. doi: 10.1002/sim.4780141709.
    1. IBM SPSS Statistics for Windows, Version 24.0. [2020-05-18].
    1. Juniper EF, Guyatt GH, Willan A, Griffith LE. Determining a minimal important change in a disease-specific quality of life questionnaire. J Clin Epidemiol. 1994 Jan;47(1):81–7. doi: 10.1016/0895-4356(94)90036-1.
    1. Drummond MF, Sculpher MJ, Torrance GW, O?Brien BJ, Stoddart GL. Methods for the Economic Evaluation of Health Care Programmes. Third Edition. Oxford, UK: Oxford University Press; 2005.
    1. Marshall DA, Hux M. Design and analysis issues for economic analysis alongside clinical trials. Med Care. 2009 Jul;47(7 Suppl 1):S14–20. doi: 10.1097/MLR.0b013e3181a31971.
    1. Wozney L, Huguet A, Bennett K, Radomski AD, Hartling L, Dyson M, McGrath PJ, Newton AS. How do ehealth programs for adolescents with depression work? A realist review of persuasive system design components in internet-based psychological therapies. J Med Internet Res. 2017 Aug 9;19(8):e266. doi: 10.2196/jmir.7573.
    1. Wright A, Hannon J, Hegedus EJ, Kavchak AE. Clinimetrics corner: a closer look at the minimal clinically important difference (MCID) J Man Manip Ther. 2012 Aug;20(3):160–6. doi: 10.1179/2042618612Y.0000000001.

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