PMID- 32706720 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20200928 IS - 2368-7959 (Print) IS - 2368-7959 (Electronic) IS - 2368-7959 (Linking) VI - 7 IP - 7 DP - 2020 Jul 24 TI - An Internet-Based Cognitive Behavioral Program for Adolescents With Anxiety: Pilot Randomized Controlled Trial. PG - e13356 LID - 10.2196/13356 [doi] LID - e13356 AB - 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; http://clinicaltrials.gov/ct2/show/NCT02059226. CI - (c)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. FAU - O'Connor, Kathleen AU - O'Connor K AUID- ORCID: 0000-0002-5910-140X AD - Glenrose Rehabilitation Hospital, Edmonton, AB, Canada. FAU - Bagnell, Alexa AU - Bagnell A AUID- ORCID: 0000-0002-1484-9676 AD - IWK Health Centre, Halifax, NS, Canada. AD - Dalhousie University, Halifax, NS, Canada. FAU - McGrath, Patrick AU - McGrath P AUID- ORCID: 0000-0002-9568-2571 AD - IWK Health Centre, Halifax, NS, Canada. AD - Dalhousie University, Halifax, NS, Canada. FAU - Wozney, Lori AU - Wozney L AUID- ORCID: 0000-0003-4280-3322 AD - IWK Health Centre, Halifax, NS, Canada. FAU - Radomski, Ashley AU - Radomski A AUID- ORCID: 0000-0003-1491-3516 AD - Department of Pediatrics, Faculty of Medicine & Dentistry, University of Alberta, Edmonton, AB, Canada. FAU - Rosychuk, Rhonda J AU - Rosychuk RJ AUID- ORCID: 0000-0001-8019-5466 AD - Department of Pediatrics, Faculty of Medicine & Dentistry, University of Alberta, Edmonton, AB, Canada. FAU - Curtis, Sarah AU - Curtis S AUID- ORCID: 0000-0003-4996-7784 AD - Department of Pediatrics, Faculty of Medicine & Dentistry, University of Alberta, Edmonton, AB, Canada. FAU - Jabbour, Mona AU - Jabbour M AUID- ORCID: 0000-0002-0031-2026 AD - Department of Neurosurgery, University of Ottawa, Ottawa, ON, Canada. FAU - Fitzpatrick, Eleanor AU - Fitzpatrick E AUID- ORCID: 0000-0001-5223-8860 AD - IWK Health Centre, Halifax, NS, Canada. FAU - Johnson, David W AU - Johnson DW AUID- ORCID: 0000-0001-8453-7849 AD - University of Calgary, Calgary, AB, Canada. FAU - Ohinmaa, Arto AU - Ohinmaa A AUID- ORCID: 0000-0002-7094-1573 AD - School of Public Health, University of Alberta, Edmonton, AB, Canada. FAU - Joyce, Anthony AU - Joyce A AUID- ORCID: 0000-0002-6728-2415 AD - University of Alberta, Edmonton, AB, Canada. FAU - Newton, Amanda AU - Newton A AUID- ORCID: 0000-0003-3020-674X AD - Department of Pediatrics, Faculty of Medicine & Dentistry, University of Alberta, Edmonton, AB, Canada. LA - eng SI - ClinicalTrials.gov/NCT02059226 PT - Journal Article DEP - 20200724 PL - Canada TA - JMIR Ment Health JT - JMIR mental health JID - 101658926 PMC - PMC7414416 OTO - NOTNLM OT - adolescents OT - anxiety OT - cognitive behavioral therapy OT - internet OT - pilot OT - randomized controlled trial COIS- 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. EDAT- 2020/07/25 06:00 MHDA- 2020/07/25 06:01 PMCR- 2020/07/24 CRDT- 2020/07/25 06:00 PHST- 2019/01/10 00:00 [received] PHST- 2020/03/21 00:00 [accepted] PHST- 2019/09/20 00:00 [revised] PHST- 2020/07/25 06:00 [entrez] PHST- 2020/07/25 06:00 [pubmed] PHST- 2020/07/25 06:01 [medline] PHST- 2020/07/24 00:00 [pmc-release] AID - v7i7e13356 [pii] AID - 10.2196/13356 [doi] PST - epublish SO - JMIR Ment Health. 2020 Jul 24;7(7):e13356. doi: 10.2196/13356.