An interventional study of web-based CBT and supportive care in Depression, Mental Disorder in Adolescence and Cognitive Behavioral Therapy, sponsored by Hallym University Medical Center. Status unknown at 3 sites in Korea, Republic of. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2014-02-26.
Sponsored by Hallym University Medical Center · Not applicable, Interventional, and Treatment
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's planned enrollment of 164 is above the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Hallym University Medical Center is the lead sponsor of 52 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Web-based CBT group : The intervention is made up of 8 internet modules based on behavioral activation, cognitive behavioral therapy
Behavioral: web-based CBT
supportive care group will receive supportive care for treating depression by e-mail per a week for 8 weeks
Behavioral: supportive care
A cognitive behavioral program in 8 weeks that will provide participants with the following: online interactive tools to do their homeworks and guidance on using cognitive and behavioral strategies to help reduce depressive symptoms, information about the depressive symptoms and cognitive behavioral therapy
Also known as: wogyeokdajim
supportive care group will receive supportive care for treating depression by e-mail per a week for 8 weeks with the following: psychoeducation about depression, stigma of mental illness, distraction technique, emotional regulation, active scheduling.
Also known as: supportive care for depressed adolescents
The Center for Epidemiological Studies of Depression (CES-D) Scale
Change in CESD from baseline Change in CESD scale between and within groups across the 8 weeks and for each assessment point
Time frame: 0, 4, 8 weeks
Subjective depressed mood scale
Change in Subjective depressed mood scale from baseline Change in Subjective depressed mood scale scale within web CBT groups across the 8 week
Time frame: each week during 8 weeks
The Korean youth self report (K-YSR)
Change in K-YSR from baseline Change in K-YSR scale between and within groups across the 8 weeks
Time frame: 0, 8 weeks
Acceptability and adherence of Web-based cognitive behavioral treatment program for adolescents with depression
After treatment, we will check out how many the participants complete the session.
Time frame: 8 weeks
satisfaction of Web-based cognitive behavioral treatment program of both adolescents with depression and their parents
After treatment, we will check out how the participants and their parent feel satisfaction about treatment
Time frame: 8 week
Columbia suicide severity rating scale
Change in CSSRS from baseline Change in CSSRS scale between and within groups across the 8 weeks and for each assessment point
Time frame: 0, 4 8 weeks after baseline assessment
Adolescent's characteristics that moderate the impact of the program
we will find out adolescent's characteristics that moderate the impact of the program
Time frame: 0, 4 and 8 weeks after baseline assessment
This study is status unknown, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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Hallym University Medical Center