Study of Web- Based Cognitive Behavioral Therapy for Depressed Korean Adolescents (wogyeokdajim)
Primary Purpose
Depression, Mental Disorder in Adolescence, Cognitive Behavioral Therapy
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
web-based CBT
supportive care
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring mood disorder, depressive disorder, mental disorders, program acceptability, behavioral symptoms, suicidal ideation, patient adherence
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
Sites / Locations
- Hallym University Sacred Heart HospitalRecruiting
- National health insurance service ilsan hospitalRecruiting
- Inje university ilsan paik hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
web-based CBT
supportive care
Arm Description
Web-based CBT group : The intervention is made up of 8 internet modules based on behavioral activation, cognitive behavioral therapy
supportive care group will receive supportive care for treating depression by e-mail per a week for 8 weeks
Outcomes
Primary Outcome Measures
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
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
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
Secondary Outcome Measures
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.
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
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
Adolescent's characteristics that moderate the impact of the program
we will find out adolescent's characteristics that moderate the impact of the program
Full Information
NCT ID
NCT02072304
First Posted
February 24, 2014
Last Updated
February 24, 2014
Sponsor
Hallym University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02072304
Brief Title
Study of Web- Based Cognitive Behavioral Therapy for Depressed Korean Adolescents
Acronym
wogyeokdajim
Official Title
Study of Web-based Cognitive Behavioral Therapy in Adolescent Depression; Randomized Controlled Trial for Korean Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
May 2015 (Anticipated)
Study Completion Date
May 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hallym University Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Mental Disorder in Adolescence, Cognitive Behavioral Therapy
Keywords
mood disorder, depressive disorder, mental disorders, program acceptability, behavioral symptoms, suicidal ideation, patient adherence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
164 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
web-based CBT
Arm Type
Experimental
Arm Description
Web-based CBT group : The intervention is made up of 8 internet modules based on behavioral activation, cognitive behavioral therapy
Arm Title
supportive care
Arm Type
Active Comparator
Arm Description
supportive care group will receive supportive care for treating depression by e-mail per a week for 8 weeks
Intervention Type
Behavioral
Intervention Name(s)
web-based CBT
Other Intervention Name(s)
wogyeokdajim
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
supportive care
Other Intervention Name(s)
supportive care for depressed adolescents
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Center for Epidemiological Studies of Depression (CES-D) Scale
Description
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
Title
Subjective depressed mood scale
Description
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
Title
The Korean youth self report (K-YSR)
Description
Change in K-YSR from baseline Change in K-YSR scale between and within groups across the 8 weeks
Time Frame
0, 8 weeks
Secondary Outcome Measure Information:
Title
Acceptability and adherence of Web-based cognitive behavioral treatment program for adolescents with depression
Description
After treatment, we will check out how many the participants complete the session.
Time Frame
8 weeks
Title
satisfaction of Web-based cognitive behavioral treatment program of both adolescents with depression and their parents
Description
After treatment, we will check out how the participants and their parent feel satisfaction about treatment
Time Frame
8 week
Title
Columbia suicide severity rating scale
Description
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
Title
Adolescent's characteristics that moderate the impact of the program
Description
we will find out adolescent's characteristics that moderate the impact of the program
Time Frame
0, 4 and 8 weeks after baseline assessment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
hyori jang, RN
Phone
10-31-381-3753
Email
hypray85@naver.com
First Name & Middle Initial & Last Name or Official Title & Degree
song-ii ahn, MD
Phone
10-31-380-3750
Email
ahnsongii83@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyun-ju hong, MD PHD
Organizational Affiliation
Associate Professor of Department of Psychiatry of Hallym University Sacred Heart Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hallym University Sacred Heart Hospital
City
Anyang -si
State/Province
Gyeonggi-do
ZIP/Postal Code
431-796
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
hyori jang, RN
Phone
10-31-381-3753
Email
• hypray85@naver.com
First Name & Middle Initial & Last Name & Degree
song-ii ahn, MD
Phone
10-31-380-3750
Email
ahnsongii83@gmail.com
First Name & Middle Initial & Last Name & Degree
Eun jin park, MD
First Name & Middle Initial & Last Name & Degree
Jungeun song, MD
Facility Name
National health insurance service ilsan hospital
City
Goyang -si
State/Province
Gyeonggi-do
ZIP/Postal Code
410-719
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jungeun song, MD
Email
songdr90@hanmail.net
Facility Name
Inje university ilsan paik hospital
City
Goyang -si
State/Province
Gyeonggi-do
ZIP/Postal Code
411-706
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eun jin park, MD
Email
uma99@daum.net
12. IPD Sharing Statement
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Study of Web- Based Cognitive Behavioral Therapy for Depressed Korean Adolescents
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