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

February 24, 2014 updated by: Hyun Ju Hong, Hallym University Medical Center

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

164

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Anyang -si, Gyeonggi-do, Korea, Republic of, 431-796
        • Recruiting
        • Hallym University Sacred Heart Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Eun jin park, MD
        • Sub-Investigator:
          • Jungeun song, MD
      • Goyang -si, Gyeonggi-do, Korea, Republic of, 410-719
        • Recruiting
        • National Health Insurance Service Ilsan Hospital
        • Contact:
      • Goyang -si, Gyeonggi-do, Korea, Republic of, 411-706
        • Recruiting
        • Inje University Ilsan Paik Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Center for Epidemiological Studies of Depression (CES-D) Scale
Time Frame: 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
0, 4, 8 weeks
Subjective depressed mood scale
Time Frame: 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
each week during 8 weeks
The Korean youth self report (K-YSR)
Time Frame: 0, 8 weeks
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
Time Frame: 8 weeks
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
Time Frame: 8 week
After treatment, we will check out how the participants and their parent feel satisfaction about treatment
8 week
Columbia suicide severity rating scale
Time Frame: 0, 4 8 weeks after baseline assessment
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
Time Frame: 0, 4 and 8 weeks after baseline assessment
we will find out adolescent's characteristics that moderate the impact of the program
0, 4 and 8 weeks after baseline assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hallym University Medical Center

Investigators

  • Principal Investigator: Hyun-ju hong, MD PHD, Associate Professor of Department of Psychiatry of Hallym University Sacred Heart Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

May 1, 2015

Study Completion (Anticipated)

May 1, 2015

Study Registration Dates

First Submitted

February 24, 2014

First Submitted That Met QC Criteria

February 24, 2014

First Posted (Estimate)

February 26, 2014

Study Record Updates

Last Update Posted (Estimate)

February 26, 2014

Last Update Submitted That Met QC Criteria

February 24, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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