Study of Web- Based Cognitive Behavioral Therapy for Depressed Korean Adolescents
NCT ID: NCT02072304
Last Updated: 2014-02-26
Study Results
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Basic Information
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UNKNOWN
NA
164 participants
INTERVENTIONAL
2014-01-31
2015-05-31
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
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
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
supportive care
supportive care group will receive supportive care for treating depression by e-mail per a week for 8 weeks
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.
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
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* participants and their parents both agree informed consents
Exclusion Criteria
* 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
12 Years
18 Years
ALL
No
Sponsors
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Hallym University Medical Center
OTHER
Responsible Party
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Hyun Ju Hong
associate professor department of psychiatry
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
National health insurance service ilsan hospital
Goyang-si, Gyeonggi-do, South Korea
Inje university ilsan paik hospital
Goyang-si, Gyeonggi-do, South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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H-001
Identifier Type: -
Identifier Source: org_study_id
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