Clinical trial NCT02072304: Study of Web- Based Cognitive Behavioral Therapy for Depressed Korean Adolescents
Official title: Study of Web-based Cognitive Behavioral Therapy in Adolescent Depression; Randomized Controlled Trial for Korean Adolescents
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Mental Disorder in Adolescence
Cognitive Behavioral Therapy
Keywords: mood disorder
depressive disorder
mental disorders
program acceptability
behavioral symptoms
suicidal ideation
patient adherence
Lead sponsor: Hallym University Medical Center
Sponsor class: OTHER
First posted: 2014-02-26
Enrollment: 164
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The Center for Epidemiological Studies of Depression (CES-D) Scale
timeFrame: 0, 4, 8 weeks
measure: Subjective depressed mood scale
timeFrame: each week during 8 weeks
measure: The Korean youth self report (K-YSR)
timeFrame: 0, 8 weeks
Secondary outcomes:
measure: Acceptability and adherence of Web-based cognitive behavioral treatment program for adolescents with depression
timeFrame: 8 weeks
measure: satisfaction of Web-based cognitive behavioral treatment program of both adolescents with depression and their parents
timeFrame: 8 week
measure: Columbia suicide severity rating scale
timeFrame: 0, 4 8 weeks after baseline assessment
measure: Adolescent's characteristics that moderate the impact of the program
timeFrame: 0, 4 and 8 weeks after baseline assessment
Other outcomes:
Locations:
city: Anyang -si
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
state: Gyeonggi-do
city: Goyang -si
country: Korea, Republic of
facility: National health insurance service ilsan hospital
state: Gyeonggi-do
city: Goyang -si
country: Korea, Republic of
facility: Inje university ilsan paik hospital
state: Gyeonggi-do
Study officials:
affiliation: Associate Professor of Department of Psychiatry of Hallym University Sacred Heart Hospital
name: Hyun-ju hong, MD PHD
role: PRINCIPAL_INVESTIGATOR
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