Digital Cognitive Behavioral Therapy for Chinese Adolescents with Depressive Symptoms (CADS-D): protocol for a randomized controlled trial.

IF 4.6 2区 医学 Q2 PSYCHIATRY
Tingting Lei, Ning Wang, Rui Wang, Yuqian He, Xueer Liu, Xinyu Zhou
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引用次数: 0

Abstract

Background: Previous studies have confirmed that digital cognitive behavioral therapy (dCBT) is an effective intervention for alleviating depressive symptoms. However, there are no specific dCBT programs available for Chinese adolescents. Therefore, we developed a smartphone-based cognitive behavioral therapy program. This study aims to evaluate the efficacy and feasibility of dCBT for Chinese adolescents with depressive symptoms.

Methods: The Digital Cognitive Behavioral Therapy for Chinese Adolescents with Depressive Symptoms (CADS-D) study is a single-center, two-arm, open-label randomized controlled trial. A total of 200 adolescents aged 12-18 years with depressive symptoms will be recruited. Key exclusion criteria include severe depressive symptoms or suicide risk, comorbid psychiatric disorders other than depressive disorders, severe physical illness or disability preventing dCBT use, current or recent treatment for depression, and inability to complete follow-up. Participants will be randomly assigned to either the intervention group, receiving the 6-week dCBT program MOCA, or the control group, receiving the regular school mental health curriculum. Assessments will be conducted at baseline (T1), post-intervention at week 6 (T2), and at a 3-month follow-up at week 18 (T3). The primary outcome is the change in depressive symptom severity from T1 to T2. Secondary outcomes, assessed at both T2 and T3, include feasibility and changes from baseline in self-reported depressive symptoms, anxiety symptoms, psychological resilience, and quality of life enjoyment and satisfaction. The first participant was enrolled in May 2025, and the study is currently ongoing.

Discussion: Findings from the CADS-D trial will provide empirical evidence regarding the efficacy and feasibility of dCBT among Chinese adolescents. If dCBT proves effective in alleviating depressive symptoms in adolescents, it will enhance therapeutic access for a wider adolescent population in China.

Trial registration: The study was registered with ClinicalTrials.gov (NCT07163013; https://clinicaltrials.gov/study/NCT07163013 ) on 9 September 2025.

中国青少年抑郁症状的数字认知行为治疗(cad - d):一项随机对照试验方案
背景:已有研究证实数字认知行为疗法(dCBT)是缓解抑郁症状的有效干预手段。然而,目前还没有专门针对中国青少年的dCBT项目。因此,我们开发了一个基于智能手机的认知行为治疗程序。本研究旨在评估dct治疗中国青少年抑郁症状的有效性和可行性。方法:数字认知行为治疗中国青少年抑郁症状(cad - d)研究是一项单中心、双臂、开放标签随机对照试验。总共将招募200名年龄在12-18岁之间有抑郁症状的青少年。主要排除标准包括严重抑郁症状或自杀风险、抑郁症以外的共病精神障碍、严重身体疾病或残疾、目前或最近的抑郁症治疗以及无法完成随访。参与者将被随机分配到干预组,接受为期6周的dCBT项目MOCA,或对照组,接受常规学校心理健康课程。评估将在基线(T1)、干预后第6周(T2)和第18周(T3)进行为期3个月的随访。主要结局是抑郁症状严重程度从T1到T2的变化。在T2和T3时评估的次要结局包括自我报告的抑郁症状、焦虑症状、心理恢复力、生活质量享受和满意度的可行性和基线变化。第一位参与者于2025年5月入组,目前研究仍在进行中。讨论:CADS-D试验的结果将为中国青少年实施dCBT的有效性和可行性提供经验证据。如果dCBT在缓解青少年抑郁症状方面被证明是有效的,它将为中国更广泛的青少年人群提供治疗。试验注册:该研究于2025年9月9日在ClinicalTrials.gov (NCT07163013; https://clinicaltrials.gov/study/NCT07163013)注册。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
BMC Psychiatry
BMC Psychiatry 医学-精神病学
CiteScore
5.90
自引率
4.50%
发文量
716
审稿时长
3-6 weeks
期刊介绍: BMC Psychiatry is an open access, peer-reviewed journal that considers articles on all aspects of the prevention, diagnosis and management of psychiatric disorders, as well as related molecular genetics, pathophysiology, and epidemiology.
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