Study of Web- Based Cognitive Behavioral Therapy for Depressed Korean Adolescents

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Depression, Mental Disorder in Adolescence, Cognitive Behavioral Therapy

Intervention / Treatment
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* Behavioral: web-based CBT
* Behavioral: supportive care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of major depressive disorder, dysthymic disorder and depressive disorder NOS participants and their parents both agree informed consents Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: web-based CBT<br>Web-based CBT group : The intervention is made up of 8 internet modules based on behavioral activation, cognitive behavioral therapy | Behavioral: web-based CBT<br>* 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<br>* Other names: wogyeokdajim;|
| Active Comparator: supportive care<br>supportive care group will receive supportive care for treating depression by e-mail per a week for 8 weeks | Behavioral: supportive care<br>* 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.<br>* Other names: supportive care for depressed adolescents;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 0, 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 | 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 | 0, 4 and 8 weeks after baseline assessment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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program acceptability, behavioral symptoms, suicidal ideation, patient adherence, mood disorder, depressive disorder, mental disorders