Digital Cognitive Behavioral Therapy for Depressive Disorders: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Montgomery-Asberg Depression Rating Scale (MADRS)
研究概览
简要总结
This study aims to explore the effectiveness of digital interventions combined with medication in the treatment of patients with depressive disorders. Its main aim is to answer: Can digital interventions combined with medication effectively alleviate symptoms of depression? The experiment will compare the effects of medication combined with digital interventions to those combined with online mental health education to evaluate their relative effectiveness. Participants will be required to engage with the medication plus digital therapy for a duration of two months, and follow-up assessments will be conducted to evaluate the long-term effects of the treatments and monitor any changes in depressive symptoms.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets the diagnostic criteria for depression according to the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition), without psychotic symptoms, as recurrent outpatient or inpatient.
- •Patients with a Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 22 before randomization.
- •Age ≥ 18 and ≤ 65 years, regardless of gender.
- •Understands the trial and signs the informed consent form.
排除标准
- •Meets criteria for other psychiatric disorders according to the DSM-5, including schizophrenia spectrum disorders, bipolar and related disorders, neurodevelopmental disorders, neurocognitive disorders, or depression due to substance and/or medication or other medical conditions.
- •History of substance and/or alcohol abuse within the past year.
- •Significant risk of suicide (MADRS item 10 score = 4).
- •Difficulty or inability to communicate verbally, understand or follow instructions, or cooperate with treatment and assessment.
- •Inability to use a smartphone.
- •Deemed unsuitable for participation by the researcher.
研究组 & 干预措施
Digital Cognitive Behavioral Therapy
干预措施: Digital Cognitive Behavioral Therapy (Behavioral)
Health Education
干预措施: Health Education (Behavioral)
Health Education
干预措施: TAU (Drug)
Digital Cognitive Behavioral Therapy
干预措施: TAU (Drug)
结局指标
主要结局
Montgomery-Asberg Depression Rating Scale (MADRS)
时间窗: baseline and immediately after 8-week intervention, and follow-ups at 4 weeks, 12 weeks, and 6 months
Score Range: 0 (best outcome) to 60 (worst outcome) Higher scores indicate worse depression symptoms.
次要结局
- GAD-7 (Generalized Anxiety Disorder-7)(baseline and weekly assessments during the treatment period, assessed up to 8 weeks, and follow-ups at 4 weeks, 12 weeks, and 6 months)
- Pittsburgh Sleep Quality Index (PSQI)(baseline, immediately after 8-week intervention, and follow-ups at 4 weeks, 12 weeks, and 6 months)
- Snaith-Hamilton Pleasure Scale (SHAPS)(baseline, immediately after 8-week intervention, and follow-ups at 4 weeks, 12 weeks, and 6 months)
- PHQ-9 (Patient Health Questionnaire-9)(baseline and weekly assessments during the treatment period, assessed up to 8 weeks, and follow-ups at 4 weeks, 12 weeks, and 6 months)
- Rumination Response Scale (RRS)(baseline, immediately after 8-week intervention, and follow-ups at 4 weeks, 12 weeks, and 6 months)