基于互联网的认知行为干预对青少年焦虑障碍的疗效：一项平行三臂随机对照试验的研究方案。
Internet-based cognitive behavioral intervention for adolescents with anxiety disorders: a study protocol for a parallel three armed randomized controlled trial.
机构信息
Research Unit for Digital Psychiatry, Center for Digital Psychiatry, Mental Health Services in the Region of Southern Denmark, Heden 11, Odense, 5000, Denmark.
Department of Clinical Research, Faculty of Health Sciences, University of Southern Denmark, Odense C, Denmark.
出版信息
Trials. 2024 Oct 13;25(1):674. doi: 10.1186/s13063-024-08511-0.
BACKGROUND
Anxiety disorders are among the most prevalent mental health concerns affecting children and adolescents. Despite their high prevalence, statistics indicate that fewer than 25% of individuals in this demographic seek professional assistance for their condition. Consequently, there is a pressing need to develop innovative interventions aimed at improving treatment accessibility.
OBJECTIVES
This study aims to assess the effectiveness of Internet-delivered Cognitive Behavioral Therapy (iCBT) for adolescents with anxiety, with a specific emphasis on involving parents in the treatment process.
METHODS
The study is structured as a parallel three-armed randomized controlled trial, comparing Internet-delivered Cognitive Behavioral Therapy (iCBT) with planned feedback, iCBT with on-demand feedback, and a waitlist control group, each group including 56 participants. Participants in the two iCBT conditions will undergo a 14-week treatment regimen, while those in the waitlist control group will wait for 14 weeks before starting iCBT with planned feedback. Additionally, participants in the iCBT groups will be randomly assigned to receive a booster session or not. The study design is factorial including two factors: type of therapist feedback (factor 1) and booster or no booster (factor 2). The study population comprises adolescents aged between 12 and 17 years, residing in Denmark, diagnosed with an anxiety disorder according to DSM-5 criteria. The primary outcome measures are the Youth Online Diagnostic Assessment and the Spence Children's Anxiety Scale. Assessments will occur at baseline, post-treatment, and at 3-, 6-, and 12-month follow-ups post-treatment.
DISCUSSION
The findings of this study are anticipated to contribute to improving the accessibility of evidence-based treatments for adolescents with anxiety.
TRIAL REGISTRATION
The study is registered at clinicalTrials.gov, under protocol ID 22/59602. The Initial release was the 16.10.2023, first posted due to technical problems 16.04.2024. https://clinicaltrials.gov/study/NCT06368557?locStr=Odense,%20Denmark&country=Denmark&city=Odense&page=2&rank=13 .
背景
焦虑症是影响儿童和青少年的最常见精神健康问题之一。尽管焦虑症的发病率很高，但统计数据表明，该人群中只有不到 25%的人寻求专业帮助来治疗他们的病情。因此，迫切需要开发创新的干预措施，以提高治疗的可及性。
目的
本研究旨在评估针对青少年焦虑症的互联网认知行为疗法（iCBT）的有效性，特别强调让父母参与治疗过程。
方法
该研究采用平行三臂随机对照试验设计，比较互联网认知行为疗法（iCBT）与计划反馈、iCBT 与按需反馈以及等待名单对照组，每组包括 56 名参与者。两个 iCBT 组的参与者将接受为期 14 周的治疗方案，而等待名单对照组的参与者将在接受计划反馈的 iCBT 治疗前等待 14 周。此外，iCBT 组的参与者将被随机分配是否接受强化疗程。该研究设计为因子设计，包括两个因素：治疗师反馈类型（因子 1）和强化疗程或非强化疗程（因子 2）。研究人群包括年龄在 12 至 17 岁之间、居住在丹麦、根据 DSM-5 标准诊断为焦虑症的青少年。主要结局指标是青少年在线诊断评估和斯宾塞儿童焦虑量表。评估将在基线、治疗后以及治疗后 3、6 和 12 个月进行。
讨论
预计本研究的结果将有助于改善青少年焦虑症的循证治疗的可及性。
试验注册
该研究在 clinicalTrials.gov 注册，协议 ID 为 22/59602。初始发布日期为 2023 年 10 月 16 日，由于技术问题于 2024 年 4 月 16 日首次发布。https://clinicaltrials.gov/study/NCT06368557?locStr=Odense,%20Denmark&country=Denmark&city=Odense&page=2&rank=13。
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