Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2026-01-07 @ 1:13 PM
Study NCT ID:
NCT02780232
Status:
UNKNOWN
Last Update Posted:
2018-05-31
First Post:
2016-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Internet-based Program for Prevention and Early Intervention of Adolescent Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-29', 'studyFirstSubmitDate': '2016-05-18', 'studyFirstSubmitQcDate': '2016-05-19', 'lastUpdatePostDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline Depressive Symptomatology at 3 months and 12 months', 'timeFrame': 'Baseline, 3 months, 12 months', 'description': 'Depressive symptomatology measured with the Patient Health Questionnaire PHQ -9 \\[6\\]'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in Health Related Quality of Life at 3 and 12 months', 'timeFrame': 'Baseline, 3 months, 12 months', 'description': 'Health Related Quality of Life Questionnaire for Children and Young People KIDSCREEN-27 \\[7\\]'}, {'measure': 'Change from Baseline in anxious symptoms at 3 and 12 months', 'timeFrame': 'Baseline, 3 months, 12 months', 'description': 'Generalised Anxiety Disorder Assessment (GAD-7) \\[8\\]'}, {'measure': 'Change from Baseline in of depression at 3 and 12 months', 'timeFrame': 'Baseline, 3 months, 12 months', 'description': 'Self-Stigma of Depression Scale (SSDS) \\[9\\]'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Depression', 'Adolescence', 'Prevention', 'Early intervention', 'E-Mental Health'], 'conditions': ['Depression']}, 'referencesModule': {'references': [{'pmid': '17007486', 'type': 'BACKGROUND', 'citation': 'Sobocki P, Jonsson B, Angst J, Rehnberg C. Cost of depression in Europe. J Ment Health Policy Econ. 2006 Jun;9(2):87-98.'}, {'pmid': '29702903', 'type': 'BACKGROUND', 'citation': 'Vargas-Zea N, Castro H, Rodriguez-Paez F, Tellez D, Salazar-Arias R. Colombian Health System on its Way to Improve Allocation Efficiency-Transition from a Health Sector Reform to the Settlement of an HTA Agency. Value Health Reg Issues. 2012 Dec;1(2):218-222. doi: 10.1016/j.vhri.2012.09.004. Epub 2012 Dec 12.'}, {'pmid': '20683846', 'type': 'BACKGROUND', 'citation': 'Barney LJ, Griffiths KM, Christensen H, Jorm AF. The Self-Stigma of Depression Scale (SSDS): development and psychometric evaluation of a new instrument. Int J Methods Psychiatr Res. 2010 Dec;19(4):243-54. doi: 10.1002/mpr.325.'}, {'type': 'BACKGROUND', 'citation': 'Fernández, J. & Gómez-Restrepo, C. Telepsiquiatría: innovación de la atención en salud mental. Una perspectiva general. Rev. Colomb. Psiquiat., 40 (3), 2011.'}, {'pmid': '21734685', 'type': 'BACKGROUND', 'citation': 'Collins PY, Patel V, Joestl SS, March D, Insel TR, Daar AS; Scientific Advisory Board and the Executive Committee of the Grand Challenges on Global Mental Health; Anderson W, Dhansay MA, Phillips A, Shurin S, Walport M, Ewart W, Savill SJ, Bordin IA, Costello EJ, Durkin M, Fairburn C, Glass RI, Hall W, Huang Y, Hyman SE, Jamison K, Kaaya S, Kapur S, Kleinman A, Ogunniyi A, Otero-Ojeda A, Poo MM, Ravindranath V, Sahakian BJ, Saxena S, Singer PA, Stein DJ. Grand challenges in global mental health. Nature. 2011 Jul 6;475(7354):27-30. doi: 10.1038/475027a. No abstract available.'}, {'pmid': '18388841', 'type': 'BACKGROUND', 'citation': 'Lowe B, Decker O, Muller S, Brahler E, Schellberg D, Herzog W, Herzberg PY. Validation and standardization of the Generalized Anxiety Disorder Screener (GAD-7) in the general population. Med Care. 2008 Mar;46(3):266-74. doi: 10.1097/MLR.0b013e318160d093.'}, {'type': 'BACKGROUND', 'citation': 'Moras, K. Twenty-five years of psychological treatment research on unipolar depression in adult outpatients: Introduction to the special section. Psychotherapy Research , 16 (5), 519-525, 2006.'}, {'pmid': '15225977', 'type': 'BACKGROUND', 'citation': 'Proudfoot JG. Computer-based treatment for anxiety and depression: is it feasible? Is it effective? Neurosci Biobehav Rev. 2004 May;28(3):353-63. doi: 10.1016/j.neubiorev.2004.03.008.'}, {'pmid': '21041282', 'type': 'BACKGROUND', 'citation': 'Richardson LP, McCauley E, Grossman DC, McCarty CA, Richards J, Russo JE, Rockhill C, Katon W. Evaluation of the Patient Health Questionnaire-9 Item for detecting major depression among adolescents. Pediatrics. 2010 Dec;126(6):1117-23. doi: 10.1542/peds.2010-0852. Epub 2010 Nov 1.'}, {'type': 'BACKGROUND', 'citation': 'KIDSCREEN Group Europe. The KIDSCREEN questionnaires. Quality of life questionnaires for children and adolescents- Handbook. Lengerich, Germany: Papst Science Publisher. 2006.'}]}, 'descriptionModule': {'briefSummary': 'Major depression is a highly prevalent and severe mental disease. Interventions based on information and communication technologies (ICTs) generate innovative opportunities to prevent and to intervene early the depression in adolescents. In Colombia, there are few preventive mental health interventions scientifically oriented and seeking to demonstrate efficacy in context.\n\nThe purpose of this study is to determine whether an internet-based program is effective to prevent and to intervene early the depression in adolescents between 13 and 19 years of age in 8 schools of the Antioquia Region, Colombia .\n\nStudy design: A cluster-randomized clinical trial will be carried out with 600 adolescents. The efficacy, adherence, and acceptability of the internet-based program will be evaluated. A single-blind randomized controlled trial will be conducted with two arms, the intervention arm (n=300), which will receive an internet-based program for depression, and the TAU (Treatment As Usual) arm (n=300).', 'detailedDescription': 'Major depression is a highly prevalent and severe mental disease that negatively alters the lives of people, their families, and their social environment.\n\nOrganizations that promote mental health policies have recognized the potential of new information technologies for the prevention and treatment of mental disorders. In this direction, information and communication technologies (ICTs) generate opportunities for increasing patient well-being through the use of on-line software. Such programs often include interactivity, self-monitoring, information materials (sometimes in multimedia format), and exercises on problem solving, recognition and challenging of dysfunctional thoughts, scheduling of activities, behavioral experiments, and other psycho-educational activities.\n\nIn Colombia, there are few preventive mental health interventions scientifically oriented and seeking to demonstrate efficacy in context.\n\nThe purpose of this study is to determine whether an internet-based program is effective to prevent and to intervene early the depression in adolescents between 13 and 19 years of age in 8 schools in the Antioquia Region, Colombia.\n\nStudy design: A cluster-randomized clinical trial will be carried out with 600 adolescents. The efficacy, adherence, and acceptability of the internet-based program will be evaluated. A single-blind randomized controlled trial will be conducted with two arms, the intervention arm (n=300), which will receive an internet-based program for depression, and the TAU arm (n=300).\n\nFollow-up times: T = 0 baseline, T= 3 months (post-intervention), T=12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Young students in schools of Antioquia between 6 and 11 high school degree, with internet access and available psychological service, foreseeing that moderate or severe depressive symptoms may be found.\n\nExclusion Criteria:\n\n* Young students with high suicide risk defined by: score equal to or greater than 2 in question 9 of PHQ-9; students who are receiving at the time treatment with antidepressant drugs and / or currently attending psychotherapy.'}, 'identificationModule': {'nctId': 'NCT02780232', 'briefTitle': 'An Internet-based Program for Prevention and Early Intervention of Adolescent Depression', 'organization': {'class': 'OTHER', 'fullName': 'CES University'}, 'officialTitle': 'A Randomized Controlled Trial of an Internet-based Program for Prevention and Early Intervention of Adolescent Depression', 'orgStudyIdInfo': {'id': 'CES577'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Internet-based program', 'description': 'Adolescents in the intervention will receive a tailored online program during 3 months.\n\nAdolescents interact with the program via a monitoring e-mail that they receive every two weeks (Monitoring) and a website which allows them to access a number of links.', 'interventionNames': ['Behavioral: Cuida tu animo / Care for your mood']}, {'type': 'NO_INTERVENTION', 'label': 'Treatment as usual', 'description': '-Waiting list control group.'}], 'interventions': [{'name': 'Cuida tu animo / Care for your mood', 'type': 'BEHAVIORAL', 'description': "CUIDA TU ÁNIMO is an online program to adolescents that provides information, education and support related to the care of the mood.\n\nAdolescents interact with the program via a monitoring e-mail that they receive every two weeks (Monitoring) and a website which allows them to access a number of links. The website have the following modules:\n\n1. What is 'CUIDA TU ÁNIMO': Description and definition of the program\n2. Psycho-educational information: Information about depression, its treatment, and opportunities for prevention\n3. How is your mood? (Monitoring): a) Online assessment of symptoms every two weeks during three months with the PHQ-3. b) Feedback\n4. Forums.\n5. Blog.\n6. Appointment (Chat or Phone call).\n7. Contact.", 'armGroupLabels': ['Internet-based program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00000', 'city': 'Medellín', 'state': 'Antioquia', 'status': 'RECRUITING', 'country': 'Colombia', 'contacts': [{'name': 'Fredy Tabares, Psychologist', 'role': 'CONTACT', 'phone': '(57) 4 2348424'}], 'facility': 'Institucion Educativa Villaflora', 'geoPoint': {'lat': 6.245, 'lon': -75.57151}}, {'zip': '0000', 'city': 'Medellín', 'state': 'Antioquia', 'status': 'RECRUITING', 'country': 'Colombia', 'contacts': [{'name': 'Astrid Restrepo, Psychologist', 'role': 'CONTACT', 'phone': '(57) 4 4274457', 'phoneExt': '00'}], 'facility': 'Institucion Educativa El Pedregal', 'geoPoint': {'lat': 6.245, 'lon': -75.57151}}, {'zip': '050034', 'city': 'Medellín', 'state': 'Antioquia', 'status': 'RECRUITING', 'country': 'Colombia', 'contacts': [{'name': 'Lina M Vallejo, Psychologist', 'role': 'CONTACT'}], 'facility': 'Institución Educativa El Corazon', 'geoPoint': {'lat': 6.245, 'lon': -75.57151}}], 'centralContacts': [{'name': 'Daniel Espinosa, MA', 'role': 'CONTACT', 'email': 'hespinosa@ces.edu.co', 'phone': '573128095486'}, {'name': 'Mauricio Fernandez, PhD', 'role': 'CONTACT', 'email': 'mauricio.fernandez@udea.edu.co', 'phone': '573113098173'}], 'overallOfficials': [{'name': 'Daniel Espinosa, MA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CES University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CES University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)', 'class': 'OTHER_GOV'}, {'name': 'Universidad de Antioquia', 'class': 'OTHER'}, {'name': 'MIDAP Millennium Institute for Research in Depression and Personality', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MA', 'investigatorFullName': 'Henry Daniel Espinosa Duque', 'investigatorAffiliation': 'CES University'}}}}