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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Hallym University Medical Center
Sponsor:
Information provided by (Responsible Party):
Hyun Ju Hong, Hallym University Medical Center
ClinicalTrials.gov Identifier:
NCT02072304
First received: February 24, 2014
Last updated: NA
Last verified: February 2014
History: No changes posted
  Purpose

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


Condition Intervention
Depression
Mental Disorder in Adolescence
Cognitive Behavioral Therapy
Behavioral: web-based CBT
Behavioral: supportive care

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

Resource links provided by NLM:


Further study details as provided by Hallym University Medical Center:

Primary Outcome Measures:
  • The Center for Epidemiological Studies of Depression (CES-D) Scale [ Time Frame: 0, 4, 8 weeks ] [ Designated as safety issue: Yes ]
    Change in CESD from baseline Change in CESD scale between and within groups across the 8 weeks and for each assessment point

  • Subjective depressed mood scale [ Time Frame: each week during 8 weeks ] [ Designated as safety issue: Yes ]
    Change in Subjective depressed mood scale from baseline Change in Subjective depressed mood scale scale within web CBT groups across the 8 week

  • The Korean youth self report (K-YSR) [ Time Frame: 0, 8 weeks ] [ Designated as safety issue: Yes ]
    Change in K-YSR from baseline Change in K-YSR scale between and within groups across the 8 weeks


Secondary Outcome Measures:
  • Acceptability and adherence of Web-based cognitive behavioral treatment program for adolescents with depression [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    After treatment, we will check out how many the participants complete the session.

  • satisfaction of Web-based cognitive behavioral treatment program of both adolescents with depression and their parents [ Time Frame: 8 week ] [ Designated as safety issue: No ]
    After treatment, we will check out how the participants and their parent feel satisfaction about treatment

  • Columbia suicide severity rating scale [ Time Frame: 0, 4 8 weeks after baseline assessment ] [ Designated as safety issue: Yes ]
    Change in CSSRS from baseline Change in CSSRS scale between and within groups across the 8 weeks and for each assessment point

  • Adolescent's characteristics that moderate the impact of the program [ Time Frame: 0, 4 and 8 weeks after baseline assessment ] [ Designated as safety issue: No ]
    we will find out adolescent's characteristics that moderate the impact of the program


Estimated Enrollment: 164
Study Start Date: January 2014
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: supportive care for depressed adolescents

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

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02072304

Contacts
Contact: hyori jang, RN 10-31-381-3753 hypray85@naver.com
Contact: song-ii ahn, MD 10-31-380-3750 ahnsongii83@gmail.com

Locations
Korea, Republic of
Hallym University Sacred Heart Hospital Recruiting
Anyang -si, Gyeonggi-do, Korea, Republic of, 431-796
Contact: hyori jang, RN    10-31-381-3753    • hypray85@naver.com   
Contact: song-ii ahn, MD    10-31-380-3750    ahnsongii83@gmail.com   
Sub-Investigator: Eun jin park, MD         
Sub-Investigator: Jungeun song, MD         
Inje university ilsan paik hospital Recruiting
Goyang -si, Gyeonggi-do, Korea, Republic of, 411-706
Contact: Eun jin park, MD       uma99@daum.net   
National health insurance service ilsan hospital Recruiting
Goyang -si, Gyeonggi-do, Korea, Republic of, 410-719
Contact: Jungeun song, MD       songdr90@hanmail.net   
Sponsors and Collaborators
Hallym University Medical Center
Investigators
Principal Investigator: Hyun-ju hong, MD PHD Associate Professor of Department of Psychiatry of Hallym University Sacred Heart Hospital
  More Information

Publications:

Responsible Party: Hyun Ju Hong, associate professor department of psychiatry, Hallym University Medical Center
ClinicalTrials.gov Identifier: NCT02072304     History of Changes
Other Study ID Numbers: H-001
Study First Received: February 24, 2014
Last Updated: February 24, 2014
Health Authority: Korea: Institutional Review Board
Korea: Ministry of Education, Science, and Technology

Keywords provided by Hallym University Medical Center:
mood disorder
depressive disorder
mental disorders
program acceptability
behavioral symptoms
suicidal ideation
patient adherence

Additional relevant MeSH terms:
Depression
Depressive Disorder
Mental Disorders
Psychotic Disorders
Behavioral Symptoms
Mood Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 25, 2014