PMID- 26825111
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20160130
LR  - 20200930
IS  - 1929-0748 (Print)
IS  - 1929-0748 (Electronic)
IS  - 1929-0748 (Linking)
VI  - 5
IP  - 1
DP  - 2016 Jan 29
TI  - Increasing Access to Mental Health Care With Breathe, an Internet-Based Program 
      for Anxious Adolescents: Study Protocol for a Pilot Randomized Controlled Trial.
PG  - e18
LID - 10.2196/resprot.4428 [doi]
LID - e18
AB  - BACKGROUND: There is a demand to make first-line treatments, including cognitive 
      behavioural therapy (CBT) for adolescent anxiety disorders, more widely 
      available. Internet-based CBT is proposed to circumvent access and availability 
      barriers and reduce health care system costs. Recent reviews suggest more 
      evidence is needed to establish the treatment effects of Internet-based CBT in 
      children and adolescents and to determine related economic impacts. OBJECTIVE: 
      This pilot trial aims to collect the necessary data to inform the planning of a 
      full-scale RCT to test the effectiveness of the Internet-based CBT program 
      Breathe (Being Real, Easing Anxiety: Tools Helping Electronically). METHODS: We 
      are conducting a 27-month, 2-arm parallel-group, pilot randomized controlled 
      trial (RCT). Outcomes will inform the planning of a full-scale RCT aimed to test 
      the effectiveness of Internet-based CBT with a population of adolescents with 
      moderate to mild anxiety problems. In the pilot RCT we will: (1) define a minimal 
      clinically important difference (MCID) for the primary outcome measure (total 
      anxiety score using the Multidimensional Anxiety Scale for Children); (2) 
      determine a sample size for the full-scale RCT; (3) estimate recruitment and 
      retention rates; (4) measure intervention acceptability to inform critical 
      intervention changes; (5) determine the use of co-interventions; and (6) conduct 
      a cost-consequence analysis to inform a cost-effectiveness analysis in the 
      full-scale RCT. Adolescents aged 13-17 years seeking care for an anxiety 
      complaint from a participating emergency department, mobile or school-based 
      crisis team, or primary care clinic are being screened for interest and 
      eligibility. Enrolled adolescents are being randomly allocated to either 8 weeks 
      of Internet-based CBT with limited telephone and e-mail support, or a control 
      group with access to a static webpage listing anxiety resources. Adolescents are 
      randomly assigned using a computer generated allocation sequence. Data are being 
      collected at baseline, treatment completion, and at a 3-month follow-up. RESULTS: 
      Currently, adolescents are being enrolled in the study. Enrolment is taking place 
      between March 2014 and February 2016; data collection will conclude May 2016. We 
      expect that analysis and results will be available by August 2016. CONCLUSIONS: 
      In many communities, the resources available for front-line anxiety treatment are 
      outweighed by the need for care. This pilot RCT is an essential step to designing 
      a robust RCT to evaluate the effectiveness of an Internet-based CBT program for 
      adolescents with moderate to mild anxiety problems. TRIAL REGISTRATION: 
      Clinicaltrials.gov NCT02059226; http://clinicaltrials.gov/ct2/show/NCT02059226 
      (Archived by WebCite at http://www.webcitation.org/6epF8v7k4).
FAU - Newton, Amanda S
AU  - Newton AS
AUID- ORCID: 0000-0003-3020-674X
AD  - University of Alberta, Edmonton, AB, Canada. mandi.newton@ualberta.ca.
FAU - Wozney, Lori
AU  - Wozney L
AUID- ORCID: 0000-0001-6933-9596
FAU - Bagnell, Alexa
AU  - Bagnell A
AUID- ORCID: 0000-0002-1484-9676
FAU - Fitzpatrick, Eleanor
AU  - Fitzpatrick E
AUID- ORCID: 0000-0001-5223-8860
FAU - Curtis, Sarah
AU  - Curtis S
AUID- ORCID: 0000-0003-4996-7784
FAU - Jabbour, Mona
AU  - Jabbour M
AUID- ORCID: 0000-0002-0031-2026
FAU - Johnson, David
AU  - Johnson D
AUID- ORCID: 0000-0001-8453-7849
FAU - Rosychuk, Rhonda J
AU  - Rosychuk RJ
AUID- ORCID: 0000-0001-8019-5466
FAU - Young, Michael
AU  - Young M
AUID- ORCID: 0000-0002-0256-3224
FAU - Ohinmaa, Arto
AU  - Ohinmaa A
AUID- ORCID: 0000-0002-7094-1573
FAU - Joyce, Anthony
AU  - Joyce A
AUID- ORCID: 0000-0002-6728-2415
FAU - McGrath, Patrick
AU  - McGrath P
AUID- ORCID: 0000-0002-9568-2571
LA  - eng
SI  - ClinicalTrials.gov/NCT02059226
PT  - Journal Article
DEP - 20160129
PL  - Canada
TA  - JMIR Res Protoc
JT  - JMIR research protocols
JID - 101599504
PMC - PMC4752691
OTO - NOTNLM
OT  - Internet
OT  - adolescents
OT  - anxiety
OT  - cognitive behavioral therapy
OT  - etherapy
OT  - intervention
OT  - mental health
OT  - pilot
OT  - randomized controlled trial
COIS- Conflicts of Interest: The IRIS platform used in this study was developed by 
      co-author Patrick McGrath and is currently being redesigned for 
      commercialization.
EDAT- 2016/01/31 06:00
MHDA- 2016/01/31 06:01
PMCR- 2016/01/29
CRDT- 2016/01/31 06:00
PHST- 2015/03/13 00:00 [received]
PHST- 2015/11/11 00:00 [accepted]
PHST- 2015/08/05 00:00 [revised]
PHST- 2016/01/31 06:00 [entrez]
PHST- 2016/01/31 06:00 [pubmed]
PHST- 2016/01/31 06:01 [medline]
PHST- 2016/01/29 00:00 [pmc-release]
AID - v5i1e18 [pii]
AID - 10.2196/resprot.4428 [doi]
PST - epublish
SO  - JMIR Res Protoc. 2016 Jan 29;5(1):e18. doi: 10.2196/resprot.4428.