Clinical trial NCT05300204: Evaluation of a Website to Improve Depression Literacy in Adolescents With Depression
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Disorder
Depression in Adolescence
Keywords: Knowledge
Mental Health
Depression Literacy
Website
Online
Adolescence
Youth
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
Collaborators: name: Prof. OTTO Beisheim Stiftung (Germany)
First posted: 2022-03-29
Enrollment: 86
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to two intervention groups in parallel for the duration of the study
Primary purpose: OTHER

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Acute suicidality
* Schizophrenic disorder
* Pervasive developmental disorder
* Bipolar disorder
* Borderline personality disorder
* Substance dependence disorder
* Insufficient knowledge of German

Primary outcomes:
measure: Depression Literacy - Self-help Strategies
timeFrame: Pre-Test, Post-Test (within 2 hours), Follow-Up 1 (Week 2), Follow-Up 2 (Week 4)
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)
Secondary outcomes:
measure: Visual Aesthetics of Websites Inventory Short Version (VisAWI-S)
timeFrame: Post-Test (within 2 hours)
measure: Overall reception of the website
timeFrame: Post-Test (within 2 hours)
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital Munich, Munich, Germany
state: Bavaria
Study officials:
affiliation: Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital Munich
name: Gerd Schulte-Körne, Professor
role: STUDY_DIRECTOR
References: