Depression Clinical Trial
Official title:
Study of Web-based Cognitive Behavioral Therapy in Adolescent Depression; Randomized Controlled Trial for Korean Adolescents
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
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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