NCT02072304

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
164

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 26, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

February 26, 2014

Status Verified

February 1, 2014

Enrollment Period

1.3 years

First QC Date

February 24, 2014

Last Update Submit

February 24, 2014

Conditions

Keywords

mood disorderdepressive disordermental disordersprogram acceptabilitybehavioral symptomssuicidal ideationpatient adherence

Outcome Measures

Primary Outcomes (3)

  • 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

    0, 4, 8 weeks

  • 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

    each week during 8 weeks

  • 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

    0, 8 weeks

Secondary Outcomes (4)

  • Acceptability and adherence of Web-based cognitive behavioral treatment program for adolescents with depression

    8 weeks

  • satisfaction of Web-based cognitive behavioral treatment program of both adolescents with depression and their parents

    8 week

  • Columbia suicide severity rating scale

    0, 4 8 weeks after baseline assessment

  • Adolescent's characteristics that moderate the impact of the program

    0, 4 and 8 weeks after baseline assessment

Study Arms (2)

web-based CBT

EXPERIMENTAL

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

Behavioral: web-based CBT

supportive care

ACTIVE COMPARATOR

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

Behavioral: supportive care

Interventions

web-based CBTBEHAVIORAL

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

Also known as: wogyeokdajim
web-based CBT
supportive careBEHAVIORAL

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.

Also known as: supportive care for depressed adolescents
supportive care

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Clinical diagnosis of major depressive disorder, dysthymic disorder and depressive disorder NOS
  • participants and their parents both agree informed consents

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hallym University Sacred Heart Hospital

Anyang-si, Gyeonggi-do, 431-796, South Korea

RECRUITING

National health insurance service ilsan hospital

Goyang-si, Gyeonggi-do, 410-719, South Korea

RECRUITING

Inje university ilsan paik hospital

Goyang-si, Gyeonggi-do, 411-706, South Korea

RECRUITING

Related Publications (11)

  • Angold A, Messer SC, Stangl D, Farmer EM, Costello EJ, Burns BJ. Perceived parental burden and service use for child and adolescent psychiatric disorders. Am J Public Health. 1998 Jan;88(1):75-80. doi: 10.2105/ajph.88.1.75.

    PMID: 9584037BACKGROUND
  • Brent DA, Perper JA, Goldstein CE, Kolko DJ, Allan MJ, Allman CJ, Zelenak JP. Risk factors for adolescent suicide. A comparison of adolescent suicide victims with suicidal inpatients. Arch Gen Psychiatry. 1988 Jun;45(6):581-8. doi: 10.1001/archpsyc.1988.01800300079011.

    PMID: 3377645BACKGROUND
  • Birmaher B, Ryan ND, Williamson DE, Brent DA, Kaufman J, Dahl RE, Perel J, Nelson B. Childhood and adolescent depression: a review of the past 10 years. Part I. J Am Acad Child Adolesc Psychiatry. 1996 Nov;35(11):1427-39. doi: 10.1097/00004583-199611000-00011.

    PMID: 8936909BACKGROUND
  • Bostwick JM, Pankratz VS. Affective disorders and suicide risk: a reexamination. Am J Psychiatry. 2000 Dec;157(12):1925-32. doi: 10.1176/appi.ajp.157.12.1925.

    PMID: 11097952BACKGROUND
  • Birmaher B, Brent D; AACAP Work Group on Quality Issues; Bernet W, Bukstein O, Walter H, Benson RS, Chrisman A, Farchione T, Greenhill L, Hamilton J, Keable H, Kinlan J, Schoettle U, Stock S, Ptakowski KK, Medicus J. Practice parameter for the assessment and treatment of children and adolescents with depressive disorders. J Am Acad Child Adolesc Psychiatry. 2007 Nov;46(11):1503-26. doi: 10.1097/chi.0b013e318145ae1c.

    PMID: 18049300BACKGROUND
  • 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.

    PMID: 15315995BACKGROUND
  • Andersson G, Cuijpers P. Internet-based and other computerized psychological treatments for adult depression: a meta-analysis. Cogn Behav Ther. 2009;38(4):196-205. doi: 10.1080/16506070903318960.

    PMID: 20183695BACKGROUND
  • 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.

    PMID: 19018321BACKGROUND
  • 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.

    PMID: 19194326BACKGROUND
  • Calear AL, Christensen H, Mackinnon A, Griffiths KM, O'Kearney R. The YouthMood Project: a cluster randomized controlled trial of an online cognitive behavioral program with adolescents. J Consult Clin Psychol. 2009 Dec;77(6):1021-32. doi: 10.1037/a0017391.

    PMID: 19968379BACKGROUND
  • Posner K, Oquendo MA, Gould M, Stanley B, Davies M. Columbia Classification Algorithm of Suicide Assessment (C-CASA): classification of suicidal events in the FDA's pediatric suicidal risk analysis of antidepressants. Am J Psychiatry. 2007 Jul;164(7):1035-43. doi: 10.1176/ajp.2007.164.7.1035.

    PMID: 17606655BACKGROUND

MeSH Terms

Conditions

DepressionMood DisordersDepressive DisorderMental DisordersBehavioral SymptomsSuicidal IdeationPatient Compliance

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

BehaviorSuicideSelf-Injurious BehaviorPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Hyun-ju hong, MD PHD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor department of psychiatry

Study Record Dates

First Submitted

February 24, 2014

First Posted

February 26, 2014

Study Start

January 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

February 26, 2014

Record last verified: 2014-02

Locations