Study of Web-based Cognitive Behavioral Therapy in Adolescent Depression; Randomized Controlled Trial for Korean Adolescents
试验速览
- 阶段
- 不适用
- 入组人数
- 164
- 试验地点
- 6
- 主要终点
- The Center for Epidemiological Studies of Depression (CES-D) Scale
研究概览
简要总结
The purpose of this study is to develope web-based cognitive behavioral therapy for Korean adoldescents who have a mild depression. And we will investigate whether web-based cognitive behavioral therapy is more effective than supportive psychotherapy for treating depressed adolescents. Our hypothesis is web- based cognitive behavioral is more effective than supportive psychotherapy
详细描述
We will recruit adolescents(age 12-18 years old) with a diagnosis of major depressive disorder, dysthymia and depressive disorder NOS in outpatient clinic of child and adolescent psychiatry and we will advertise for recruitment of subjects in community. The study protocol will be approved by the Institutional Review Board of the Hallym university sacred heart hospital. Well- trained interviewers will conduct the assessments of participants and their parents or guardians. The assessment included the diagnostic interview, demographic characteristics, depressive symptom severity scale , Columbia suicide severity rating scale, questionnaire about abuse histories.
We decided the number of participants of 164, because in previous studies, web- based cognitive behavioral therapy showed mild to moderate effect size (effect size = 0.43). So for examining the hypothesis, we will recruit 164 adolescents by calculating the number of participants using G power program version 3.1.3. (level of significance = 5%, power of a hypothesis test = 80%, drop out rate = 20%)
And we will conduct randomized controlled trial for examining the efficacy of web- based cognitive behavioral therapy. Our hypothesis is web- based cognitive behavioral is more effective than supportive psychotherapy, so we will deliver web- based cognitive behavioral therapy program to cognitive behavioral therapy group for 8 weeks(once in a week), and supportive psychotherapy to supportive psychotherapy group for 8 weeks(once in a week) We will exclude the participant if the participant has severe depressive symptoms, definite suicidal idea, plan and attempt, psychotic symptoms, bipolar disorders, sexual abuse histories, other neurological diseases or received cognitive behavioral therapy, pharmacotherapy or interpersonal psychotherapy.
We will analyze the intent- to- treat population. For each individual, missing values are replaced by the last observed value of that variable. And we will use Chi square test or repeated measure-ANOVA.
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
- None
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
- •Clinical diagnosis of major depressive disorder, dysthymic disorder and depressive disorder NOS
- •participants and their parents both agree informed consents
排除标准
- •participants have psychotic symptoms, developmental disorders,
- •participants are diagnosed by bipolar disorder
- •participants are current high risk of suicide
- •participants have psychiatric and physical symptoms need urgent medicine treatment
- •participants have a history of sexual abuse
- •participants have cognitive behavioral therapy or interpersonal psychotherapy within 3 months
- •participants have a history of brain injury or a neurological disorder such as seizure disorder, or severe physical disorder
研究组 & 干预措施
web-based CBT
Web-based CBT group : The intervention is made up of 8 internet modules based on behavioral activation, cognitive behavioral therapy
干预措施: web-based CBT (Behavioral)
supportive care
supportive care group will receive supportive care for treating depression by e-mail per a week for 8 weeks
干预措施: supportive care (Behavioral)
结局指标
主要结局
The Center for Epidemiological Studies of Depression (CES-D) Scale
时间窗: 0, 4, 8 weeks
Change in CESD from baseline Change in CESD scale between and within groups across the 8 weeks and for each assessment point
The Korean youth self report (K-YSR)
时间窗: 0, 8 weeks
Change in K-YSR from baseline Change in K-YSR scale between and within groups across the 8 weeks
Subjective depressed mood scale
时间窗: each week during 8 weeks
Change in Subjective depressed mood scale from baseline Change in Subjective depressed mood scale scale within web CBT groups across the 8 week
次要结局
- satisfaction of Web-based cognitive behavioral treatment program of both adolescents with depression and their parents(8 week)
- Adolescent's characteristics that moderate the impact of the program(0, 4 and 8 weeks after baseline assessment)
- Columbia suicide severity rating scale(0, 4 8 weeks after baseline assessment)
- Acceptability and adherence of Web-based cognitive behavioral treatment program for adolescents with depression(8 weeks)
研究者
Hyun Ju Hong
associate professor department of psychiatry
Hallym University Medical Center
