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临床试验/NCT02072304
NCT02072304Unknown不适用

Study of Web-based Cognitive Behavioral Therapy in Adolescent Depression; Randomized Controlled Trial for Korean Adolescents

Hallym University Medical Center6 个研究点 分布在 2 个国家目标入组 164 人开始时间: 2014年1月最近更新:
适应症
干预措施

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

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

Experimental

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

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hyun Ju Hong

associate professor department of psychiatry

Hallym University Medical Center

研究点 (6)

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