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

NCT ID: NCT02072304

Last Updated: 2014-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-05-31

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.

Conditions

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Depression Mental Disorder in Adolescence Cognitive Behavioral Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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web-based CBT

Web-based CBT group : The intervention is made up of 8 internet modules based on behavioral activation, cognitive behavioral therapy

Group Type EXPERIMENTAL

web-based CBT

Intervention Type BEHAVIORAL

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

supportive care

supportive care group will receive supportive care for treating depression by e-mail per a week for 8 weeks

Group Type ACTIVE_COMPARATOR

supportive care

Intervention Type BEHAVIORAL

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.

Interventions

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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

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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wogyeokdajim supportive care for depressed adolescents

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
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hallym University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Hyun Ju Hong

associate professor department of psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hyun-ju hong, MD PHD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor of Department of Psychiatry of Hallym University Sacred Heart Hospital

Locations

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Hallym University Sacred Heart Hospital

Anyang-si, Gyeonggi-do, South Korea

Site Status RECRUITING

National health insurance service ilsan hospital

Goyang-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Inje university ilsan paik hospital

Goyang-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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hyori jang, RN

Role: CONTACT

10-31-381-3753

song-ii ahn, MD

Role: CONTACT

10-31-380-3750

Facility Contacts

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Jungeun song, MD

Role: primary

Eun jin park, MD

Role: primary

hyori jang, RN

Role: primary

10-31-381-3753

song-ii ahn, MD

Role: backup

10-31-380-3750

References

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March J, Silva S, Petrycki S, Curry J, Wells K, Fairbank J, Burns B, Domino M, McNulty S, Vitiello B, Severe J; Treatment for Adolescents With Depression Study (TADS) Team. Fluoxetine, cognitive-behavioral therapy, and their combination for adolescents with depression: Treatment for Adolescents With Depression Study (TADS) randomized controlled trial. JAMA. 2004 Aug 18;292(7):807-20. doi: 10.1001/jama.292.7.807.

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Van Voorhees BW, Vanderplough-Booth K, Fogel J, Gladstone T, Bell C, Stuart S, Gollan J, Bradford N, Domanico R, Fagan B, Ross R, Larson J, Watson N, Paunesku D, Melkonian S, Kuwabara S, Holper T, Shank N, Saner D, Butler A, Chandler A, Louie T, Weinstein C, Collins S, Baldwin M, Wassel A, Reinecke MA. Integrative internet-based depression prevention for adolescents: a randomized clinical trial in primary care for vulnerability and protective factors. J Can Acad Child Adolesc Psychiatry. 2008 Nov;17(4):184-96.

Reference Type BACKGROUND
PMID: 19018321 (View on PubMed)

Van Voorhees BW, Fogel J, Reinecke MA, Gladstone T, Stuart S, Gollan J, Bradford N, Domanico R, Fagan B, Ross R, Larson J, Watson N, Paunesku D, Melkonian S, Kuwabara S, Holper T, Shank N, Saner D, Butler A, Chandler A, Louie T, Weinstein C, Collins S, Baldwin M, Wassel A, Vanderplough-Booth K, Humensky J, Bell C. Randomized clinical trial of an Internet-based depression prevention program for adolescents (Project CATCH-IT) in primary care: 12-week outcomes. J Dev Behav Pediatr. 2009 Feb;30(1):23-37. doi: 10.1097/DBP.0b013e3181966c2a.

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Reference Type BACKGROUND
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Reference Type BACKGROUND
PMID: 17606655 (View on PubMed)

Other Identifiers

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H-001

Identifier Type: -

Identifier Source: org_study_id

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