Digital Cognitive Behavioral Therapy for Chinese Adolescents With Depressive Symptoms（CADS-D ): A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in CDRS-R (Children's Depression Rating Scale) scores from baseline
研究概览
简要总结
CADS-D aimes to evaluate the effectiveness and feasibility of a newly DCBT program for Chinese adolescents with depressive symptoms.
详细描述
CADS-D is a single-center, two-arm, open-label randomized controlled trial. The trial targeted 12-18 years adolescents with depressive symptoms. Intervention group receives the digital cognitive behavioral therapy (DCBT) program for 6 weeks, while the control group receives the regular mental health curriculum provided by school staff for 6 weeks. Assessments are conducted at three time points: baseline, post-intervention (6 weeks), and at 3 months follow-up (18 weeks). The primary outcome is the effectiveness of DCBT. Secondary outcomes include the feasibility of DCBT, self-reported depressive severity, anxiety severity, psychological resilience, and the quality of life enjoyment and satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
As the intervention measure set in this study, it is impossible to blind participants or intervention providers. Trained research assistants who are blinded to intervention will conduct the assessment, and data analyst are kept blind to the allocation.
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 12 to 18 years;
- •Scored 28 or higher on the children's depression rating scale-revised (CDRS-R);
- •Have the ability to read and write in Chinese;
- •Participant and at least one of their guardians provided written consent;
- •Have access to mobile phone and internet.
排除标准
- •The researchers assessed that the adolescent's depressive symptoms were too severe to participate to CADS-D;
- •Scored 5 or higher on item 13 (suicidal ideation) on CDRS-R;
- •Participants who met diagnosis of other mental disorder except depression;
- •Severe physical illnesses or other physical disabilities that prevented the use of DCBT;
- •Within the past three months or currently undergoing any antidepressant treatment, including medication therapy, psychotherapy, and physical therapy;
- •Unavailability to follow up months after intervention.
研究组 & 干预措施
Digital cognitive behavioral therapy Group
Participants in the intervention group are required to complete two module a week and all modules were be delivered in 6 weeks after the program starts.
干预措施: Digital cognitive behavioral therapy(DCBT) (Other)
Regular mental health curriculum Group
The participants of control group are allocated to regular mental health curriculum provided by school staff for 6 weeks.
干预措施: Regular mental health curriculum (Other)
结局指标
主要结局
Change in CDRS-R (Children's Depression Rating Scale) scores from baseline
时间窗: Baseline of intervention period, 6 weeks, and 3 months follow-up (18 weeks)
Children's Depression Rating Scale is a 17 items observer-rated scale developed specifically for children and adolescents. Total scores range from 17-113, with higher scores indicating greater severity of depressive symptoms.
次要结局
- Feasibility of DCBT(6 weeks)
- Changes in PHQ (9-item Patient Health Questionnaire) scores from baseline(Baseline of intervention period, 6 weeks, and 3 months follow-up (18 weeks))
- Changes in GAD-7 (Generalized Anxiety Disorder 7-item Scale) scores from baseline(Baseline of intervention period, 6 weeks, and 3 months follow-up (18 weeks))
- Changes in CD-RISC ( Connor-Davidson Resilience Scale) scores from baseline(Baseline of intervention period, 6 weeks, and 3 months follow-up (18 weeks))
- Changes in PQ-LES-Q (The Paediatric Quality of Life Enjoyment and Satisfaction Questionnaire) scores from baseline(Baseline of intervention period, 6 weeks, and 3 months follow-up (18 weeks))
研究者
Xinyu Zhou
Professor
First Affiliated Hospital of Chongqing Medical University