Depressive DisorderNCT05300204
Evaluation of a Website to Improve Depression Literacy in Adolescents With Depression
A study testing Self-help strategies for depression and General information about depression in people with Depressive Disorder and Depression in Adolescence, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Depressive Disorder, Depression in Adolescence
- What is being tested?
- Self-help strategies for depression and General information about depression
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteGermany
- Study dates
- 4 Jan 2021to 2 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
- 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.
- Intelligence quotient (IQ) of ≥ 80.
Who cannot join
- Acute suicidality
- Schizophrenic disorder
- Pervasive developmental disorder
- Bipolar disorder
- Borderline personality disorder
- Substance dependence disorder
- Insufficient knowledge of German
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital Munich, Munich, Germany
Munich, Bavaria, 80336
About this study
Official title: 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
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.
Read the 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 1. A study focusing on target group 2 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 adolescents with acute or remitted depressive disorder.
- Conditions
- Depressive Disorder, Depression in Adolescence
- Being tested
- Self-help strategies for depression, General information about depression
- Keywords
- Knowledge, Mental Health, Depression Literacy, Website, Online, Adolescence, Youth
- Medical subject headings
- Depressive Disorder, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-help strategies for depressionOther
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 self-help strategies for depression.
General information about depressionOther
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group 1 - Self-help Strategies for depression | Experimental | Exposure to information about self-help strategies for depression Receives: Other: Self-help strategies for depression |
| Intervention Group 2 - General information about depression | Experimental | Exposure to general information about depression Receives: Other: General information about depression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression Literacy - Self-help Strategies
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.
Measured: Pre-Test, Post-Test (within 2 hours), Follow-Up 1 (Week 2), Follow-Up 2 (Week 4)
Depression Literacy - Depression as psychiatric disorder
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
Measured: Pre-Test, Post-Test (within 2 hours), Follow-Up 1 (Week 2), Follow-Up 2 (Week 4)
Secondary outcomes (2)
Visual Aesthetics of Websites Inventory Short Version (VisAWI-S)
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")
Measured: Post-Test (within 2 hours)
Overall reception of the website
The overall reception of the website as measured with a self-designed questionnaire
Measured: Post-Test (within 2 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start4 Jan 2021
- Primary completion2 May 2022
- Study completion2 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to two intervention groups in parallel for the duration of the study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Prof. Otto Beisheim Foundation
- Responsible party
- Principal investigator, Ellen Greimel, Ludwig-Maximilians - University of Munich
- Investigators
- Gerd Schulte-Körne, Professor, Study director, Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05300204
- Sponsor's protocol ID
- 20114_2
- Status last verified
- Jul 2022
- First submitted
- 10 Mar 2022
- Last updated
- 27 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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. 2026 Feb;143:109429. doi: 10.1016/j.pec.2025.109429. Epub 2025 Nov 27.
PubMed 41337834
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05300204
- Acronym / sponsor ID
- 20114_2
- Conditions
- Depressive Disorder, Depression in Adolescence
- Keywords
- Knowledge, Mental Health, Depression Literacy, Website, Online, Adolescence, Youth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- Prof. Otto Beisheim Foundation
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 2 May 2022 (actual)
- Study completion
- 2 May 2022 (actual)
- First posted
- 29 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 1. A study focusing on target group 2 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 adolescents with acute or remitted depressive disorder.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants are assigned to two intervention groups in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| Intervention Group 1 - Self-help Strategies for depression | Experimental | Other: Self-help strategies for depressionExposure to information about self-help strategies for depression |
| Intervention Group 2 - General information about depression | Experimental | Other: General information about depressionExposure to general information about depression |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
- 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.
- Intelligence quotient (IQ) of ≥ 80.
Key exclusion criteria (7 listed)
- Acute suicidality
- Schizophrenic disorder
- Pervasive developmental disorder
- Bipolar disorder
- Borderline personality disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-help strategies for depressionBefore 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 self-help strategies for depression. | Other | Intervention Group 1 - Self-help Strategies for depression |
| General information about depressionBefore 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 | Other | Intervention Group 2 - General information about depression |
Primary outcome
Depression Literacy - Self-help Strategies
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 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.
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
2 secondary outcomes
Visual Aesthetics of Websites Inventory Short Version (VisAWI-S)
Time frame: Post-Test (within 2 hours)
Overall reception of the website
Time frame: Post-Test (within 2 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Derived from this study: PubMed 41337834Kloek 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. 2026 Feb;143:109429. doi: 10.1016/j.pec.2025.109429. Epub 2025 Nov 27.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerd Schulte-Körne, Professor study director
Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-help strategies for depression and General information about depression in people with Depressive Disorder and Depression in Adolescence, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression Literacy - Self-help Strategies (time frame: Pre-Test, Post-Test (within 2 hours), Follow-Up 1 (Week 2), Follow-Up 2 (Week 4)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05300204, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2022.