Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-02-24 @ 11:01 AM
Study NCT ID:
NCT02072304
Status:
UNKNOWN
Last Update Posted:
2014-02-26
First Post:
2014-02-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Web- Based Cognitive Behavioral Therapy for Depressed Korean Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D059020', 'term': 'Suicidal Ideation'}, {'id': 'D010349', 'term': 'Patient Compliance'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D013405', 'term': 'Suicide'}, {'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010166', 'term': 'Palliative Care'}], 'ancestors': [{'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 164}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2015-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-02-24', 'studyFirstSubmitDate': '2014-02-24', 'studyFirstSubmitQcDate': '2014-02-24', 'lastUpdatePostDateStruct': {'date': '2014-02-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Center for Epidemiological Studies of Depression (CES-D) Scale', 'timeFrame': '0, 4, 8 weeks', 'description': 'Change in CESD from baseline Change in CESD scale between and within groups across the 8 weeks and for each assessment point'}, {'measure': 'Subjective depressed mood scale', 'timeFrame': 'each week during 8 weeks', 'description': 'Change in Subjective depressed mood scale from baseline Change in Subjective depressed mood scale scale within web CBT groups across the 8 week'}, {'measure': 'The Korean youth self report (K-YSR)', 'timeFrame': '0, 8 weeks', 'description': 'Change in K-YSR from baseline Change in K-YSR scale between and within groups across the 8 weeks'}], 'secondaryOutcomes': [{'measure': 'Acceptability and adherence of Web-based cognitive behavioral treatment program for adolescents with depression', 'timeFrame': '8 weeks', 'description': 'After treatment, we will check out how many the participants complete the session.'}, {'measure': 'satisfaction of Web-based cognitive behavioral treatment program of both adolescents with depression and their parents', 'timeFrame': '8 week', 'description': 'After treatment, we will check out how the participants and their parent feel satisfaction about treatment'}, {'measure': 'Columbia suicide severity rating scale', 'timeFrame': '0, 4 8 weeks after baseline assessment', 'description': 'Change in CSSRS from baseline Change in CSSRS scale between and within groups across the 8 weeks and for each assessment point'}, {'measure': "Adolescent's characteristics that moderate the impact of the program", 'timeFrame': '0, 4 and 8 weeks after baseline assessment', 'description': "we will find out adolescent's characteristics that moderate the impact of the program"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['mood disorder', 'depressive disorder', 'mental disorders', 'program acceptability', 'behavioral symptoms', 'suicidal ideation', 'patient adherence'], 'conditions': ['Depression', 'Mental Disorder in Adolescence', 'Cognitive Behavioral Therapy']}, 'referencesModule': {'references': [{'pmid': '9584037', 'type': 'BACKGROUND', 'citation': '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': '3377645', 'type': 'BACKGROUND', 'citation': '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': '8936909', 'type': 'BACKGROUND', 'citation': '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': '11097952', 'type': 'BACKGROUND', 'citation': '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': '18049300', 'type': 'BACKGROUND', 'citation': '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': '15315995', 'type': 'BACKGROUND', 'citation': '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': '20183695', 'type': 'BACKGROUND', 'citation': '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': '19018321', 'type': 'BACKGROUND', 'citation': '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': '19194326', 'type': 'BACKGROUND', 'citation': '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': '19968379', 'type': 'BACKGROUND', 'citation': "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': '17606655', 'type': 'BACKGROUND', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.\n\nWe 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%)\n\nAnd 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.\n\nWe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of major depressive disorder, dysthymic disorder and depressive disorder NOS\n* participants and their parents both agree informed consents\n\nExclusion Criteria:\n\n* participants have psychotic symptoms, developmental disorders,\n* participants are diagnosed by bipolar disorder\n* participants are current high risk of suicide\n* participants have psychiatric and physical symptoms need urgent medicine treatment\n* participants have a history of sexual abuse\n* participants have cognitive behavioral therapy or interpersonal psychotherapy within 3 months\n* participants have a history of brain injury or a neurological disorder such as seizure disorder, or severe physical disorder'}, 'identificationModule': {'nctId': 'NCT02072304', 'acronym': 'wogyeokdajim', 'briefTitle': 'Study of Web- Based Cognitive Behavioral Therapy for Depressed Korean Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'Hallym University Medical Center'}, 'officialTitle': 'Study of Web-based Cognitive Behavioral Therapy in Adolescent Depression; Randomized Controlled Trial for Korean Adolescents', 'orgStudyIdInfo': {'id': 'H-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'web-based CBT', 'description': 'Web-based CBT group : The intervention is made up of 8 internet modules based on behavioral activation, cognitive behavioral therapy', 'interventionNames': ['Behavioral: web-based CBT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'supportive care', 'description': 'supportive care group will receive supportive care for treating depression by e-mail per a week for 8 weeks', 'interventionNames': ['Behavioral: supportive care']}], 'interventions': [{'name': 'web-based CBT', 'type': 'BEHAVIORAL', 'otherNames': ['wogyeokdajim'], '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', 'armGroupLabels': ['web-based CBT']}, {'name': 'supportive care', 'type': 'BEHAVIORAL', 'otherNames': ['supportive care for depressed adolescents'], '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.', 'armGroupLabels': ['supportive care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '431-796', 'city': 'Anyang-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'hyori jang, RN', 'role': 'CONTACT', 'email': '• hypray85@naver.com', 'phone': '10-31-381-3753'}, {'name': 'song-ii ahn, MD', 'role': 'CONTACT', 'email': 'ahnsongii83@gmail.com', 'phone': '10-31-380-3750'}, {'name': 'Eun jin park, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jungeun song, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hallym University Sacred Heart Hospital', 'geoPoint': {'lat': 37.3925, 'lon': 126.92694}}, {'zip': '410-719', 'city': 'Goyang-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jungeun song, MD', 'role': 'CONTACT', 'email': 'songdr90@hanmail.net'}], 'facility': 'National health insurance service ilsan hospital', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}, {'zip': '411-706', 'city': 'Goyang-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Eun jin park, MD', 'role': 'CONTACT', 'email': 'uma99@daum.net'}], 'facility': 'Inje university ilsan paik hospital', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}], 'centralContacts': [{'name': 'hyori jang, RN', 'role': 'CONTACT', 'email': 'hypray85@naver.com', 'phone': '10-31-381-3753'}, {'name': 'song-ii ahn, MD', 'role': 'CONTACT', 'email': 'ahnsongii83@gmail.com', 'phone': '10-31-380-3750'}], 'overallOfficials': [{'name': 'Hyun-ju hong, MD PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate Professor of Department of Psychiatry of Hallym University Sacred Heart Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hallym University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor department of psychiatry', 'investigatorFullName': 'Hyun Ju Hong', 'investigatorAffiliation': 'Hallym University Medical Center'}}}}