Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2026-01-10 @ 6:36 PM
Study NCT ID:
NCT03093467
Status:
COMPLETED
Last Update Posted:
2021-04-08
First Post:
2017-03-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of an Internet-based Intervention for the Treatment of Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000928', 'term': 'Antidepressive Agents'}, {'id': 'D014151', 'term': 'Anti-Anxiety Agents'}, {'id': 'D014150', 'term': 'Antipsychotic Agents'}, {'id': 'D011613', 'term': 'Psychotherapy'}], 'ancestors': [{'id': 'D011619', 'term': 'Psychotropic Drugs'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D014149', 'term': 'Tranquilizing Agents'}, {'id': 'D002492', 'term': 'Central Nervous System Depressants'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Open randomized controlled trial in one mental health center.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 167}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-05', 'studyFirstSubmitDate': '2017-03-14', 'studyFirstSubmitQcDate': '2017-03-22', 'lastUpdatePostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of attended and missed treatment appointments', 'timeFrame': 'Months 6 and 9.', 'description': "Adherence to treatment in terms of patients' attendance to medical controls and psychotherapy sessions."}, {'measure': 'Number of patients that dropout from treatment', 'timeFrame': 'Months 6 and 9.', 'description': 'Number of patients that dropout from psychiatric or psychotherapeutic treatment during the observation period.'}], 'primaryOutcomes': [{'measure': "Change in depressivity assessed with the Beck's Depression Inventory I (BDI-I)", 'timeFrame': 'Baseline, months 6 and 9.', 'description': "Beck's Depression Inventory I (BDI-I) total score (score range 0 - 63)"}], 'secondaryOutcomes': [{'measure': 'Change in quality of life change assessed with the EuroQol/EQ-5D', 'timeFrame': 'Baseline, months 6 and 9.', 'description': 'EuroQol/EQ-5D (EQ-index range 0 - 1)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Internet', 'Mental Health'], 'conditions': ['Depression']}, 'referencesModule': {'references': [{'pmid': '22051709', 'type': 'BACKGROUND', 'citation': 'Alvarado R, Rojas G. [Evaluation of the program for detection and treatment of depression in Chilean primary health care centers]. Rev Med Chil. 2011 May;139(5):592-9. Epub 2011 Sep 16. Spanish.'}, {'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': '26741190', 'type': 'BACKGROUND', 'citation': 'Espinosa HD, Carrasco A, Moessner M, Caceres C, Gloger S, Rojas G, Perez JC, Vanegas J, Bauer S, Krause M. Acceptability Study of "Ascenso": An Online Program for Monitoring and Supporting Patients with Depression in Chile. Telemed J E Health. 2016 Jul;22(7):577-83. doi: 10.1089/tmj.2015.0124. Epub 2016 Jan 7.'}, {'pmid': '17657327', 'type': 'BACKGROUND', 'citation': 'Fritsch R, Araya R, Solis J, Montt E, Pilowsky D, Rojas G. [A randomized trial of pharmacotherapy with telephone monitoring to improve treatment of depression in primary care in Santiago, Chile]. Rev Med Chil. 2007 May;135(5):587-95. Epub 2007 Jul 9. Spanish.'}, {'pmid': '25803266', 'type': 'BACKGROUND', 'citation': 'Hamine S, Gerth-Guyette E, Faulx D, Green BB, Ginsburg AS. Impact of mHealth chronic disease management on treatment adherence and patient outcomes: a systematic review. J Med Internet Res. 2015 Feb 24;17(2):e52. doi: 10.2196/jmir.3951.'}, {'pmid': '26808817', 'type': 'BACKGROUND', 'citation': 'Kordy H, Wolf M, Aulich K, Burgy M, Hegerl U, Husing J, Puschner B, Rummel-Kluge C, Vedder H, Backenstrass M. Internet-Delivered Disease Management for Recurrent Depression: A Multicenter Randomized Controlled Trial. Psychother Psychosom. 2016;85(2):91-8. doi: 10.1159/000441951. Epub 2016 Jan 26.'}, {'pmid': '15550801', 'type': 'BACKGROUND', 'citation': 'Neumeyer-Gromen A, Lampert T, Stark K, Kallischnigg G. Disease management programs for depression: a systematic review and meta-analysis of randomized controlled trials. Med Care. 2004 Dec;42(12):1211-21. doi: 10.1097/00005650-200412000-00008.'}, {'pmid': '34927594', 'type': 'DERIVED', 'citation': 'Perez JC, Fernandez O, Caceres C, Carrasco AE, Moessner M, Bauer S, Espinosa-Duque D, Gloger S, Krause M. An Adjunctive Internet-Based Intervention to Enhance Treatment for Depression in Adults: Randomized Controlled Trial. JMIR Ment Health. 2021 Dec 16;8(12):e26814. doi: 10.2196/26814.'}], 'seeAlsoLinks': [{'url': 'http://ww3.psicomedica.cl/', 'label': 'Mental health clinic. Recruitment center.'}, {'url': 'http://midap.org', 'label': 'Millennium Institute for research on depression and personality'}, {'url': 'http://psyres.de/', 'label': 'Center for psychotherapy research, Heidelberg University Hospital'}, {'url': 'http://www.conicyt.cl/fonis/', 'label': 'Fund for research and development in health'}]}, 'descriptionModule': {'briefSummary': "Depression is a highly prevalent disorder in Chile, generating important personal and social costs. This study aims to evaluate the effectiveness of the internet-based program ASCENSO as an adjunct intervention for the treatment of depression. ASCENSO provides information to promote patients' self-care, it monitors reported depression symptoms providing automatized feedback and provides the possibility of booking a counseling session via chat or by phone. To evaluate the effectiveness of ASCENSO, an open, evaluator-blind, prospective, parallel-group (one intervention group and one active control group) randomized controlled trial will be implemented in one mental health center in Santiago of Chile. The sample will be composed of adults initiating treatment for depression, and who have internet access. Participants will be randomly assigned to one of the two study arms. Randomization will be stratified by the number of patients´ previous episodes (dichotomized into none, 1 or more), following a permuted block randomization procedure. Patients in the experimental group (n=100) will receive the usual treatment plus access to the ASCENSO program. The control group (n=100) will only receive the usual treatment. At recruitment, months 6 and 9, patients' self-reported depression symptoms and quality of life will be assessed. Additionally, adherence to treatment in terms of patients' attendance to medical controls and psychotherapy sessions will be registered for both research groups.", 'detailedDescription': 'The public health system has established policies and priorities to provide access to depression treatment and to improve the quality of those services. The acknowledgment of the complexity and chronicity of the disorder has motivated the design and implementation of comprehensive disease management strategies for depression. There are experiences that show that information technologies can help to optimize the management of depression. If ASCENSO is effective, it could be a useful resource to include to the mental health services for depression in Chile.\n\nThe components of the ASCENSO program are:\n\nEmergency. Standard Information on what to do and who to contact in a crisis situation.\n\nOnline or phone counseling. Patients can schedule a 30-minute session with a psychologist, which is conducted in a private text chatroom or over the phone.\n\nMonitoring. Patients receive a bi-weekly email with a link to the monitoring questionnaire and automatized tailored feedback message. If a participant reports severe impairment, the ASCENSO administrator receives an alert notification and then contacts the patient.\n\nSelf-care information and blog. Web pages with basic information about depression and self-care recommendations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of major depression disorder\n* Internet access\n\nExclusion Criteria:\n\n* previous suicide attempt\n* hospitalization for a previous depressive episode\n* a history of psychotic symptoms\n* bipolar disorder\n* organic brain disorders\n* any serious disorders related to substance abuse or dependence\n* antisocial personality disorder\n* a serious medical condition or severe cognitive impairment\n* lack of knowledge of the Spanish language\n* illiteracy\n* refusal or revocation of patient consent.\n\nPatients will be evaluated using the MINI International Neuropsychiatric interview, Spanish for Chile Translation Version 6.0.0.'}, 'identificationModule': {'nctId': 'NCT03093467', 'acronym': 'ASCENSO', 'briefTitle': 'Effectiveness of an Internet-based Intervention for the Treatment of Depression', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Milenio para Investigación en Depresión y Personalidad'}, 'officialTitle': 'Effectiveness of an Internet-based Intervention for the Treatment of Depression: Towards the Improvement of the Management of Depression', 'orgStudyIdInfo': {'id': 'SA16I0173'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Participants receive psychiatric treatment and psychotherapy as usual. In addition, participants have access to the internet-based program ASCENSO: an adjunct support and monitoring system for the treatment of depression.', 'interventionNames': ['Behavioral: ASCENSO', 'Drug: Antidepressants or in combination with anxiolytics, neuroleptics or mood stabilizers.', 'Behavioral: Psychotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Patients receive psychiatric treatment and psychotherapy as usual.', 'interventionNames': ['Drug: Antidepressants or in combination with anxiolytics, neuroleptics or mood stabilizers.', 'Behavioral: Psychotherapy']}], 'interventions': [{'name': 'ASCENSO', 'type': 'BEHAVIORAL', 'otherNames': ['Internet-based program'], 'description': 'Internet-based program: an adjunct support and monitoring system for the treatment of depression.', 'armGroupLabels': ['Experimental']}, {'name': 'Antidepressants or in combination with anxiolytics, neuroleptics or mood stabilizers.', 'type': 'DRUG', 'otherNames': ['Psychiatric treatment'], 'description': 'Usual psychiatric treatment which may include drugs: antidepressant monotherapy or antidepressants in combination with anxiolytics, neuroleptics or mood stabilizers as needed, according to the psychiatric evaluation. Monthly controls during 5 months in average.', 'armGroupLabels': ['Control', 'Experimental']}, {'name': 'Psychotherapy', 'type': 'BEHAVIORAL', 'description': 'Usual treatment: brief psychotherapy. One session per week, a total of 9 sessions in average.', 'armGroupLabels': ['Control', 'Experimental']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Santiago', 'state': 'RM', 'country': 'Chile', 'facility': 'Psicomedica', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}], 'overallOfficials': [{'name': 'Álvaro E. Carrasco, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Millennium institute for research on depression and personality (MIDAP)'}, {'name': 'Janet C. Pérez, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Millennium institute for research on depression and personality (MIDAP)'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Beginning 3 months and ending 5 years following article publication', 'ipdSharing': 'YES', 'description': 'Individual quantitative participant data that underlie the reported results, after deidentification (text, tables and figures).', 'accessCriteria': 'These data will be available to researchers who provide a methodologically sound proposal for the purposes of achieving specific aims outlined in that proposal. Proposals should be directed to J. Carola Pérez via email (janetperez@udd.cl) or Olga Fernandez (mofernandez36@gmail.com) and will be reviewed by both researchers. Requests to access data to undertake hypothesis-driven research will not be unreasonably withheld. To gain access, data requesters will need to sign a data access agreement and to confirm that data will only be used for the agreed purpose for which access was granted and this these data will be not shared to other people.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Milenio para Investigación en Depresión y Personalidad', 'class': 'OTHER'}, 'collaborators': [{'name': 'Psicomedica Clinical & Research Group, Chile', 'class': 'UNKNOWN'}, {'name': 'University Hospital Heidelberg', 'class': 'OTHER'}, {'name': 'National Fund for Research and Development in Health, Chile', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Researcher', 'investigatorFullName': 'Álvaro Carrasco', 'investigatorAffiliation': 'Instituto Milenio para Investigación en Depresión y Personalidad'}}}}