Newton Amanda S, Wozney Lori, Bagnell Alexa, Fitzpatrick Eleanor, Curtis Sarah, Jabbour Mona, Johnson David, Rosychuk Rhonda J, Young Michael, Ohinmaa Arto, Joyce Anthony, McGrath Patrick
University of Alberta, Edmonton, AB, Canada.
JMIR Res Protoc. 2016 Jan 29;5(1):e18. doi: 10.2196/resprot.4428.
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.
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).
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.
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.
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.
Clinicaltrials.gov NCT02059226; http://clinicaltrials.gov/ct2/show/NCT02059226 (Archived by WebCite at http://www.webcitation.org/6epF8v7k4).
人们需要让包括针对青少年焦虑症的认知行为疗法（CBT）在内的一线治疗方法更广泛地可得。基于互联网的CBT被提议用于克服获取和可得性障碍，并降低医疗保健系统成本。近期的综述表明，需要更多证据来确立基于互联网的CBT对儿童和青少年的治疗效果，并确定相关的经济影响。
这项试点试验旨在收集必要数据，为全面随机对照试验（RCT）的规划提供信息，以测试基于互联网的CBT项目“呼吸（直面现实，缓解焦虑：电子辅助工具）”的有效性。
我们正在进行一项为期27个月的双臂平行组试点随机对照试验（RCT）。研究结果将为全面RCT的规划提供信息，该全面RCT旨在测试基于互联网的CBT对患有中度至轻度焦虑问题的青少年群体的有效性。在试点RCT中，我们将：（1）为主要结局指标（使用儿童多维焦虑量表的总焦虑得分）定义最小临床重要差异（MCID）；（2）确定全面RCT的样本量；（3）估计招募和留存率；（4）衡量干预的可接受性，为关键的干预改进提供信息；（5）确定联合干预措施的使用情况；（6）进行成本后果分析，为全面RCT中的成本效益分析提供信息。正在对年龄在13至17岁、因焦虑问题向参与研究的急诊科、流动或学校危机干预团队或初级保健诊所寻求治疗的青少年进行兴趣和资格筛查。入选的青少年被随机分配到接受为期8周的基于互联网的CBT并获得有限的电话和电子邮件支持组，或被分配到可访问列出焦虑资源的静态网页的对照组。使用计算机生成的分配序列对青少年进行随机分配。在基线、治疗结束时和3个月随访时收集数据。
目前，青少年正在参与该研究。招募工作于2014年3月至2016年2月进行；数据收集将于2016年5月结束。我们预计分析和结果将于2016年8月可得。
在许多社区，一线焦虑治疗可用资源无法满足治疗需求。这项试点RCT是设计一项有力的RCT以评估基于互联网的CBT项目对患有中度至轻度焦虑问题的青少年有效性的关键一步。
Clinicaltrials.gov NCT02059226；http://clinicaltrials.gov/ct2/show/NCT02059226（由WebCite存档于http://www.webcitation.org/6epF8v7k4）。
