Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-25 @ 6:57 PM
Study NCT ID:
NCT05300204
Status:
COMPLETED
Last Update Posted:
2022-07-27
First Post:
2022-03-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of a Website to Improve Depression Literacy in Adolescents With Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants are not aware of the assigned intervention group'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are assigned to two intervention groups in parallel for the duration of the study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-05-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-26', 'studyFirstSubmitDate': '2022-03-10', 'studyFirstSubmitQcDate': '2022-03-18', 'lastUpdatePostDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depression Literacy - Self-help Strategies', 'timeFrame': 'Pre-Test, Post-Test (within 2 hours), Follow-Up 1 (Week 2), Follow-Up 2 (Week 4)', 'description': 'This self-designed questionnaire is a self-report inventory to assess knowledge of self-help strategies for depression (12 items), with higher scores indicating more knowledge of self-help strategies. Participants will complete this self-designed questionnaire at pre-test, post-test and the two follow-ups to determine change in knowledge of self-help strategies.'}, {'measure': 'Depression Literacy - Depression as psychiatric disorder', 'timeFrame': 'Pre-Test, Post-Test (within 2 hours), Follow-Up 1 (Week 2), Follow-Up 2 (Week 4)', 'description': 'This self-designed questionnaire is a self-report inventory to assess knowledge of depression as psychiatric disorder (frequency and comorbidities, treatment, symptoms, causes and course of depression; 27 items), with higher scores indicating more knowledge of depression as psychiatric disorder. Participants will complete this self-designed questionnaire at pre-test, post-test and the two follow-ups to determine change in knowledge of depression as psychiatric disorder'}], 'secondaryOutcomes': [{'measure': 'Visual Aesthetics of Websites Inventory Short Version (VisAWI-S)', 'timeFrame': 'Post-Test (within 2 hours)', 'description': 'The short version of the Visual Aesthetics of Websites Inventory (VisAWI-S) is self-report inventory to assess the evaluation of the website\'s design - especially the perceived visual aesthetics. Participants indicated their response to the four items (e.g., "The layout appears professionally designed") on a seven-point Likert scale (ranging from 1 "do not agree at all" to 7 "do fully agree")'}, {'measure': 'Overall reception of the website', 'timeFrame': 'Post-Test (within 2 hours)', 'description': 'The overall reception of the website as measured with a self-designed questionnaire'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Knowledge', 'Mental Health', 'Depression Literacy', 'Website', 'Online', 'Adolescence', 'Youth'], 'conditions': ['Depressive Disorder', 'Depression in Adolescence']}, 'referencesModule': {'references': [{'pmid': '41337834', 'type': 'DERIVED', 'citation': 'Kloek MWH, Primbs R, Kaubisch S, Iglhaut L, Piechaczek CE, Zsigo C, Keim PM, Feldmann L, Schulte-Korne G, Greimel E. Effectiveness and acceptance of tailored web-based psychoeducation for adolescents with major depression. Patient Educ Couns. 2025 Nov 27;143:109429. doi: 10.1016/j.pec.2025.109429. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the efficacy and acceptability of the website "ich bin alles" (https://www.ich-bin-alles.de/) to improve depression literacy (knowledge about depression, which aid the recognition, treatment or prevention of depression) in adolescents with acute or remitted depressive disorder. The investigators will examine whether the website improves depression literacy in adolescents aged 12 to 18 years with a history of depression. The investigators will also assess the acceptability of the website among the adolescents.', 'detailedDescription': 'Few young people with major depressive disorder seek professional treatment in time. Concerns about social stigma, confidentiality, and limited knowledge about mental health conditions, such as depression, or mental health services are some of the main barriers to seek treatment. To address these problems, we developed an evidence-based website "ich bin alles" (https://www.ich-bin-alles.de/) to improve depression literacy.\n\nTo improve depression literacy, the website provides general information about depression as psychiatric disorder in adolescents (e.g., symptoms, causes, course and treatment of depression). Furthermore, the website provides information about self-help strategies for depression and prevention of depression; i.e., strategies for promoting mental health (e.g., reducing stress, doing exercise, undertaking positive activities), which are meant to serve as an addition to professional treatments of depression or to promote mental health in adolescents.\n\nTarget groups of the website are adolescents aged 12 to 18 years seeking help for depression, as well as healthy adolescents seeking information about mental health promotion or depression. Easy access to information about depression would make early recognition of depression more likely and engage young people to seek help for depression.\n\nSince the website targets two different groups, the investigators will evaluate the website accordingly:\n\nTarget group 1: Adolescents with a major depressive disorder (acute or remitted) Target group 2: Healthy Adolescents (no mental health condition)\n\nThe current study will focus on target group 1. A study focusing on target group 2 can be found in a separately registered clinical trial on clinicaltrials.gov.\n\nThe primary aim of this study is to evaluate the efficacy and acceptability of the website "ich bin alles" (https://www.ich-bin-alles.de/) to improve depression literacy in adolescents with acute or remitted depressive disorder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The presence of a current or remitted diagnosis of a mild, moderate, or severe major depressive episode according to ICD-10 Criteria: F32.0; F32.1; F32.2, F33.0, F33.1, F.33.2) is assessed using a semi structured clinical Interview: the "Kinder-DIPS". The Kinder-DIPS is a well-established German interview for the diagnosis of a wide range of axis I psychiatric disorders in children from ages six to 18.\n* Depressive symptomatology is measured as well with the Beck Depression Inventory Second Edition (BDI-II) for descriptive purposes. The BDI-II is a self-report inventory to assess the severity of depressive symptoms, rated on a 4-point response scale, with higher scores indicating more severe depressive symptoms.\n* Intelligence quotient (IQ) of ≥ 80.\n\nExclusion Criteria:\n\n* Acute suicidality\n* Schizophrenic disorder\n* Pervasive developmental disorder\n* Bipolar disorder\n* Borderline personality disorder\n* Substance dependence disorder\n* Insufficient knowledge of German'}, 'identificationModule': {'nctId': 'NCT05300204', 'briefTitle': 'Evaluation of a Website to Improve Depression Literacy in Adolescents With Depression', 'organization': {'class': 'OTHER', 'fullName': 'Ludwig-Maximilians - University of Munich'}, 'officialTitle': 'Evaluating the Efficacy and the Acceptability of the Website "Ich Bin Alles" to Improve Depression Literacy in Adolescents With Acute or Remitted Major Depressive Disorder', 'orgStudyIdInfo': {'id': '20114_2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group 1 - Self-help Strategies for depression', 'description': 'Exposure to information about self-help strategies for depression', 'interventionNames': ['Other: Self-help strategies for depression']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention Group 2 - General information about depression', 'description': 'Exposure to general information about depression', 'interventionNames': ['Other: General information about depression']}], 'interventions': [{'name': 'Self-help strategies for depression', 'type': 'OTHER', 'description': 'Before starting the intervention, the participants are told that they will be shown parts of a website about depression. The participants are instructed to carefully attend to the website (e.g., to read the text precisely, to hear attentively to the podcasts and to view carefully the videos and images on the website). The time window spent for the reception of each part of the website are fixed.\n\nThe participants in this intervention group will only be shown parts of the website regarding self-help strategies for depression.', 'armGroupLabels': ['Intervention Group 1 - Self-help Strategies for depression']}, {'name': 'General information about depression', 'type': 'OTHER', 'description': 'Before starting the intervention, the participants are told that they will be shown parts of a website about depression. The participants are instructed to carefully attend to the website (e.g., to read the text precisely, to hear attentively to the podcasts and to view carefully the videos and images on the website). The time window spent for the reception of each part of the website are fixed.\n\nThe participants in this intervention group will only be shown parts of the website regarding general information about depression', 'armGroupLabels': ['Intervention Group 2 - General information about depression']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80336', 'city': 'Munich', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital Munich, Munich, Germany', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'overallOfficials': [{'name': 'Gerd Schulte-Körne, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital Munich'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data in our study contains sensitive patient information, such as sociodemographic information and comorbidities. Since patients could possibly be identified by making our raw data publicly available, ethical principles of protecting patient confidentiality would be breached. Aggregated group data can be made available upon request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ludwig-Maximilians - University of Munich', 'class': 'OTHER'}, 'collaborators': [{'name': 'Prof. Otto Beisheim Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Postdoctoral Researcher', 'investigatorFullName': 'Ellen Greimel', 'investigatorAffiliation': 'Ludwig-Maximilians - University of Munich'}}}}