Stepped Care Internet-Delivered vs Face-to-Face Cognitive-Behavior Therapy for Pediatric Obsessive-Compulsive Disorder: A Trial Protocol for a Randomized Noninferiority Trial

Kristina Aspvall, Erik Andersson, Fabian Lenhard, Karin Melin, Lisa Norlin, Lena Wallin, Maria Silverberg-Mörse, Inna Feldman, Matteo Bottai, David Mataix-Cols, Eva Serlachius, Kristina Aspvall, Erik Andersson, Fabian Lenhard, Karin Melin, Lisa Norlin, Lena Wallin, Maria Silverberg-Mörse, Inna Feldman, Matteo Bottai, David Mataix-Cols, Eva Serlachius

Abstract

Importance: Internet-delivered cognitive behavior therapy is an effective treatment for children and adolescents with obsessive-compulsive disorder and has the potential to markedly increase access to treatment for patients while being cost-effective for health care organizations.

Objective: To investigate whether internet-delivered cognitive behavior therapy implemented within a stepped care model is noninferior to, and cost-effective compared with, the gold standard of face-to-face cognitive behavior therapy for pediatric obsessive-compulsive disorder.

Design, setting, and participants: Multicenter, single-blind, randomized clinical noninferiority trial implemented at 2 specialist pediatric obsessive-compulsive disorder clinics in Stockholm and Gothenburg, Sweden. Participants are 152 children and adolescents aged 7 to 17 years with obsessive compulsive disorder, recruited through the 2 clinics and online self-referral. Patients will be randomized 1:1 to the stepped care intervention or face-to-face therapy. Blind evaluations will be conducted after treatment and at 3-month and 6-month follow-ups. At the 6-month follow-up (primary end point), noninferiority will be tested and resource use will be compared between the 2 treatment groups. Data will be analyzed according to intention-to-treat principles.

Intervention: Patients randomized to stepped care will first receive internet-delivered cognitive behavior therapy for 16 weeks; patients who are classified as nonresponders 3 months after treatment completion will receive additional face-to-face therapy. The control group will receive 16 weeks of face-to-face cognitive behavior therapy immediately following randomization and nonresponders at the 3-month follow-up will, as in the stepped care group, receive additional face-to-face therapy.

Main outcomes and measures: Noninferiority is defined as a 4-point difference on the primary outcome measure (Children's Yale-Brown Obsessive Compulsive Scale).

Discussion: Recruitment started October 6, 2017, and was completed May 24, 2019. Results from the primary end point will be available by May 2020. The naturalistic follow-ups (1, 2, and 5 years after the end of treatment) will continue to 2025. There are no interim analyses planned or stopping rules for the trial.

Trial registration: ClinicalTrials.gov identifier: NCT03263546.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Andersson reported receiving book royalties from Natur & Kultur outside the submitted work. Dr Mataix-Cols reported receiving personal fees from UpToDate, Wolters Kluwer Health, and Elsevier outside the submitted work. No other disclosures were reported.

Figures

Figure.. CONSORT Flowchart
Figure.. CONSORT Flowchart
Abbreviations: CBT, cognitive behavior therapy; ICBT, internet-delivered CBT.

References

    1. National Institute for Health and Care Excellence Obsessive-compulsive disorder and body dysmorphic disorder: treatment. . Accessed April 29, 2019.
    1. Geller DA, March J. Practice parameter for the assessment and treatment of children and adolescents with obsessive-compulsive disorder. J Am Acad Child Adolesc Psychiatry. 2012;51(1):-. doi:10.1016/j.jaac.2011.09.019
    1. Öst L-G, Riise EN, Wergeland GJ, Hansen B, Kvale G. Cognitive behavioral and pharmacological treatments of OCD in children: a systematic review and meta-analysis. J Anxiety Disord. 2016;43:58-69. doi:10.1016/j.janxdis.2016.08.003
    1. Melin K, Skarphedinsson G, Thomsen PH, et al. . Treatment gains are sustainable in pediatric obsessive-compulsive disorder: three-year follow-up from the NordLOTS [published online February 14, 2019]. J Am Acad Child Adolesc Psychiatry.
    1. Franklin ME, Sapyta J, Freeman JB, et al. . Cognitive behavior therapy augmentation of pharmacotherapy in pediatric obsessive-compulsive disorder: the Pediatric OCD Treatment Study II (POTS II) randomized controlled trial. JAMA. 2011;306(11):1224-1232. doi:10.1001/jama.2011.1344
    1. Skarphedinsson G, Weidle B, Thomsen PH, et al. . Continued cognitive-behavior therapy versus sertraline for children and adolescents with obsessive-compulsive disorder that were non-responders to cognitive-behavior therapy: a randomized controlled trial. Eur Child Adolesc Psychiatry. 2015;24(5):591-602. doi:10.1007/s00787-014-0613-0
    1. Schwartz C, Schlegl S, Kuelz AK, Voderholzer U. Treatment-seeking in OCD community cases and psychological treatment actually provided to treatment-seeking patients: a systematic review. J Obsessive Compuls Relat Disord. 2013;2(4):448-456. doi:10.1016/j.jocrd.2013.10.006
    1. Krebs G, Isomura K, Lang K, et al. . How resistant is ‘treatment-resistant’ obsessive-compulsive disorder in youth? Br J Clin Psychol. 2015;54(1):63-75. doi:10.1111/bjc.12061
    1. Shapiro DA, Cavanagh K, Lomas H. Geographic inequity in the availability of cognitive behavioural therapy in England and Wales. Behav Cogn Psychother. 2003;31(02):185-192. doi:10.1017/S1352465803002066
    1. Marques L, LeBlanc NJ, Weingarden HM, Timpano KR, Jenike M, Wilhelm S. Barriers to treatment and service utilization in an internet sample of individuals with obsessive-compulsive symptoms. Depress Anxiety. 2010;27(5):470-475. doi:10.1002/da.20694
    1. Griffiths F, Lindenmeyer A, Powell J, Lowe P, Thorogood M. Why are health care interventions delivered over the internet? a systematic review of the published literature. J Med Internet Res. 2006;8(2):e10. doi:10.2196/jmir.8.2.e10
    1. Aspvall K, Andrén P, Lenhard F, Andersson E, Mataix-Cols D, Serlachius E. Internet-delivered cognitive behavioural therapy for young children with obsessive-compulsive disorder: development and initial evaluation of the BIP OCD Junior programme. BJPsych Open. 2018;4(3):106-112. doi:10.1192/bjo.2018.10
    1. Lenhard F, Vigerland S, Andersson E, et al. . Internet-delivered cognitive behavior therapy for adolescents with obsessive-compulsive disorder: an open trial. PLoS One. 2014;9(6):e100773. doi:10.1371/journal.pone.0100773
    1. Lenhard F, Andersson E, Mataix-Cols D, et al. . Therapist-guided, internet-delivered cognitive-behavioral therapy for adolescents with obsessive-compulsive disorder: a randomized controlled trial. J Am Acad Child Adolesc Psychiatry. 2017;56(1):10-19.e2. doi:10.1016/j.jaac.2016.09.515
    1. Lenhard F, Ssegonja R, Andersson E, et al. . Cost-effectiveness of therapist-guided internet-delivered cognitive behaviour therapy for paediatric obsessive-compulsive disorder: results from a randomised controlled trial. BMJ Open. 2017;7(5):e015246. doi:10.1136/bmjopen-2016-015246
    1. Jolstedt M, Wahlund T, Lenhard F, et al. . Efficacy and cost-effectiveness of therapist-guided internet cognitive behavioural therapy for paediatric anxiety disorders: a single-centre, single-blind, randomised controlled trial. Lancet Child Adolesc Health. 2018;2(11):792-801. doi:10.1016/S2352-4642(18)30275-X
    1. Vigerland S, Ljótsson B, Thulin U, Öst LG, Andersson G, Serlachius E. Internet-delivered cognitive behavioural therapy for children with anxiety disorders: a randomised controlled trial. Behav Res Ther. 2016;76:47-56. doi:10.1016/j.brat.2015.11.006
    1. Mataix-Cols D, Marks IM. Self-help with minimal therapist contact for obsessive-compulsive disorder: a review. Eur Psychiatry. 2006;21(2):75-80. doi:10.1016/j.eurpsy.2005.07.003
    1. Chan A-W, Tetzlaff JM, Altman DG, et al. . SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200-207. doi:10.7326/0003-4819-158-3-201302050-00583
    1. Statistics Sweden Kommuner i siffror. . Accessed August 23rd, 2019.
    1. Sheehan DV, Sheehan KH, Shytle RD, et al. . Reliability and validity of the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID). J Clin Psychiatry. 2010;71(3):313-326. doi:10.4088/JCP.09m05305whi
    1. Scahill L, Riddle MA, McSwiggin-Hardin M, et al. . Children’s Yale-Brown Obsessive Compulsive Scale: reliability and validity. J Am Acad Child Adolesc Psychiatry. 1997;36(6):844-852. doi:10.1097/00004583-199706000-00023
    1. Guy W. ECDEU Assessment Manual for Psychopharmacology. Vol 76 Rockville, MD: US Department of Health, Education and Welfare; 1976.
    1. Shaffer D, Gould MS, Brasic J, et al. . A Children’s Global Assessment Scale (CGAS). Arch Gen Psychiatry. 1983;40(11):1228-1231. doi:10.1001/archpsyc.1983.01790100074010
    1. American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders. 5th ed Washington, DC: American Psychiatric Association; 2013.
    1. Başoğlu M, Marks I, Livanou M, Swinson R. Double-blindness procedures, rater blindness, and ratings of outcome: observations from a controlled trial. Arch Gen Psychiatry. 1997;54(8):744-748. doi:10.1001/archpsyc.1997.01830200078011
    1. Karolinska Institutet BIP OCD. . Accessed September 15, 2019.
    1. Turner CM, Mataix-Cols D, Lovell K, et al. . Telephone cognitive-behavioral therapy for adolescents with obsessive-compulsive disorder: a randomized controlled non-inferiority trial. J Am Acad Child Adolesc Psychiatry. 2014;53(12):1298-1307.e2. doi:10.1016/j.jaac.2014.09.012
    1. March JS, Mulle K. OCD in Children and Adolescents: A Cognitive-Behavioral Treatment Manual. New York, NY: Guilford Press; 1998.
    1. Mataix-Cols D, Fernández de la Cruz L, Nordsletten AE, Lenhard F, Isomura K, Simpson HB. Towards an international expert consensus for defining treatment response, remission, recovery and relapse in obsessive-compulsive disorder. World Psychiatry. 2016;15(1):80-81. doi:10.1002/wps.20299
    1. Foa EB, Coles M, Huppert JD, Pasupuleti RV, Franklin ME, March J. Development and validation of a child version of the obsessive compulsive inventory. Behav Ther. 2010;41(1):121-132. doi:10.1016/j.beth.2009.02.001
    1. Shafran R, Frampton I, Heyman I, Reynolds M, Teachman B, Rachman S. The preliminary development of a new self-report measure for OCD in young people. J Adolesc. 2003;26(1):137-142. doi:10.1016/S0140-1971(02)00083-0
    1. Pinto A, Van Noppen B, Calvocoressi L. Development and preliminary psychometric evaluation of a self-rated version of the Family Accommodation Scale for Obsessive-Compulsive Disorder. J Obsessive Compuls Relat Disord. 2013;2(4):457-465. doi:10.1016/j.jocrd.2012.06.001
    1. Jassi A, Lenhard F, Krebs G, et al. The work and social adjustment scale, youth and parent versions: psychometric evaluation of a brief measure of functional impairment in young people [published online July 3, 2019].
    1. Angold A, Costello EJ, Messer SC, Pickles A. Development of a short questionnaire for use in epidemiological studies of depression in children and adolescents. Int J Methods Psychiatr Res. 1995;5(4):237-249.
    1. Bastien CH, Vallières A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001;2(4):297-307. doi:10.1016/S1389-9457(00)00065-4
    1. Stevens K. Assessing the performance of a new generic measure of health-related quality of life for children and refining it for use in health state valuation. Appl Health Econ Health Policy. 2011;9(3):157-169. doi:10.2165/11587350-000000000-00000
    1. Bouwmans C, De Jong K, Timman R, 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. doi:10.1186/1472-6963-13-217
    1. Allison C, Auyeung B, Baron-Cohen S. Toward brief “red flags” for autism screening: the Short Autism Spectrum Quotient and the Short Quantitative Checklist for Autism in toddlers in 1,000 cases and 3,000 controls [corrected]. J Am Acad Child Adolesc Psychiatry. 2012;51(2):202-212.e7. doi:10.1016/j.jaac.2011.11.003
    1. Borkovec TD, Nau SD. Credibility of analogue therapy rationales. J Behav Ther Exp Psychiatry. 1972;3(4):257-260. doi:10.1016/0005-7916(72)90045-6
    1. Andrusyna TP, Tang TZ, DeRubeis RJ, Luborsky L. The factor structure of the working alliance inventory in cognitive-behavioral therapy. J Psychother Pract Res. 2001;10(3):173-178.
    1. Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5(3):233-237. doi:10.1016/0149-7189(82)90074-X
    1. Simpson HB, Maher M, Page JR, Gibbons CJ, Franklin ME, Foa EB. Development of a patient adherence scale for exposure and response prevention therapy. Behav Ther. 2010;41(1):30-37. doi:10.1016/j.beth.2008.12.002
    1. Lenhard F, Mitsell K, Jolstedt M, et al. . The Internet Intervention Patient Adherence Scale for Guided Internet-Delivered Behavioral Interventions: Development and Psychometric Evaluation. J Med Internet Res. 2019;21(10):e13602. doi:10.2196/13602
    1. Moher D, Hopewell S, Schulz KF, et al. . CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c869. doi:10.1136/bmj.c869
    1. Rubin DB. Multiple Imputation for Nonresponse in Surveys. New York, NY: John Wiley & Sons; 1987. doi:10.1002/9780470316696
    1. Bridges JFP, Hauber AB, Marshall D, et al. . Conjoint analysis applications in health—a checklist: a report of the ISPOR Good Research Practices for Conjoint Analysis Task Force. Value Health. 2011;14(4):403-413. doi:10.1016/j.jval.2010.11.013
    1. Statens beredning för medicinsk och social utvärdering (SBU). Hälsoekonomiska utvärderingar. . Accessed April 29, 2019.
    1. Matthews JNS, Altman DG, Campbell MJ, Royston P. Analysis of serial measurements in medical research. BMJ. 1990;300(6719):230-235. doi:10.1136/bmj.300.6719.230
    1. Manning WG, Mullahy J. Estimating log models: to transform or not to transform? J Health Econ. 2001;20(4):461-494. doi:10.1016/S0167-6296(01)00086-8
    1. Drummond MF, Sculpher MJ, Claxton K, Stoddart GL, Torrance GW. Methods for the Economic Evaluation of Health Care Programmes 4th ed. Oxford, England: Oxford University Press; 2015.
    1. World Medical Association World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013;310(20):2191-2194. doi:10.1001/jama.2013.281053
    1. Piaggio G, Elbourne DR, Pocock SJ, Evans SJ, Altman DG; CONSORT Group . Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement. JAMA. 2012;308(24):2594-2604. doi:10.1001/jama.2012.87802
    1. Husereau D, Drummond M, Petrou S, et al. ; CHEERS Task Force . Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement. BJOG. 2013;120(6):765-770. doi:10.1111/1471-0528.12241

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