- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05300217
Evaluation of a Website to Improve Depression Literacy in Adoldescents
Evaluating the Efficacy and the Acceptability of the Website "Ich Bin Alles" to Improve Depression Literacy in Adolescents
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
To 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.
Target 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.
Since the website targets two different groups, the investigators will evaluate the website accordingly:
Target group 1: Adolescents with a major depressive disorder (acute or remitted) Target group 2: Healthy Adolescents (no mental health condition) The current study will focus on target group 2. A study focusing on target group 1 can be found in a separately registered clinical trial on clinicaltrials.gov.
The 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 healthy adolescents.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Bayern
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Munich, Bayern, Germany, 80336
- Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital Munich
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Intelligence quotient (IQ) of ≥ 80
Exclusion Criteria:
- Current diagnosis of a mental disorder
- Remitted depressive disorder
- Insufficient knowledge of German
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Group 2 - General information about depression
Exposure to general information about depression
|
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. The participants in this intervention group will only be shown parts of the website regarding general information about depression |
Experimental: Intervention Group 1 - Strategies for promoting mental health
Exposure to information about strategies for promoting mental health
|
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 images on the website). The time window spent for the reception of each part of the website are fixed. The participants in this intervention group will only be shown parts of the website regarding strategies for promoting mental health |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression Literacy - Depression as psychiatric disorder
Time Frame: Pre-Test, Post-Test (within 2 hours), Follow-Up 1 (Week 2), Follow-Up 2 (Week 4)
|
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
|
Pre-Test, Post-Test (within 2 hours), Follow-Up 1 (Week 2), Follow-Up 2 (Week 4)
|
Depression Literacy - Strategies for promoting mental health
Time Frame: Pre-Test, Post-Test (within 2 hours), Follow-Up 1 (Week 2), Follow-Up 2 (Week 4)
|
This self-designed questionnaire is a self-report inventory to assess knowledge of strategies for promoting mental health (exercise, dealing with problems and stress, positive attitude, postive activities and social contacts; 27 items), with higher scores indicating more knowledge of strategies for promoting mental health.
Participants will complete this self-designed questionnaire at pre-test, post-test and the two follow-ups to determine change in knowledge of strategies for promoting mental health.
|
Pre-Test, Post-Test (within 2 hours), Follow-Up 1 (Week 2), Follow-Up 2 (Week 4)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Aesthetics of Websites Inventory Short Version (VisAWI-S)
Time Frame: Post-Test (within 2 hours)
|
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")
|
Post-Test (within 2 hours)
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Overall reception of the website
Time Frame: Post-Test (within 2 hours)
|
The overall reception of the website as measured with a self-designed questionnaire
|
Post-Test (within 2 hours)
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20115_2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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