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Completed

NCT Number: NCT04994496

Web-based Self-help Intervention Promoting Mental Health in Adolescents

This study aims to evaluate the feasibility and effectiveness of a web-based self-help intervention promoting mental health in adolescents. We will examine whether this intervention improves positive affect, reduces stress and alleviates negative affect and depressive symptoms in adolescents aged 12 to 18 years. We will also investigate the rates of adherence among the adolescents who use this web-based intervention and the acceptability of the intervention with adolescents.

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Key information

Conditions

Mental Health Behavior Behavioral Symptoms Depression Depressive Symptoms Personal Satisfaction Positive Thinking Psychological Well-Being Stress

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital Munich, Munich, Germany

Munich, Bavaria, 80336, Germany

About this study

The prevalence of mental health problems including depression rises during adolescence. Nevertheless, young people often have little knowledge about mental health problems and conditions, such as depression, and how they can be prevented. Besides limited knowledge, concerns about social stigma, confidentiality and limited access to mental health services are some of the main barriers to seek help. Therefore, highly acceptable and easily accessible services promoting mental health, such as knowledge about mental health conditions and effective self-help strategies to prevent them, are urgently needed for adolescents.

We developed a website, which provides evidence-based information about depressive disorders in youth (e.g., identification, etiology, treatment, and prevention of depression) and will be launched in autumn 2021. Furthermore, the website provides information about self-help strategies (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 prevention of depression.

To increase the acceptability of the website and the engagement of young people, the website will integrate continuously updating content consisting of short exercises based on principles of positive psychology. This web-based self-help intervention is thought to provide a mode of delivery (the combination: "online" & "positive psychology"), which is acceptable and engaging to youth, and might effectively promote mental health in adolescents.

Since the website targets two different groups, we will evaluate the web-based self-help intervention 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 the study is to evaluate the feasibility and effectiveness of this web-based self-help intervention to improve positive affect, reduce stress, alleviate negative affect and depressive symptoms in adolescents.

Participating young people will be randomized to either the web-based intervention group or a web-based control group (i.e. sham intervention / comparator). All participants will be evaluated at pre-, post-intervention, and at a two-week follow-up.

Hypothesis: Participants in the web-based intervention group will report a significant decrease of negative affect, depressive symptoms and perceived stress compared to participants in the web-based control group. Participants in the web-based intervention group will report a significant increase of positive affect compared to participants in the web-based control group

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Intelligence quotient (IQ) of ≥ 80

Exclusion criteria

  • Current diagnosis of a mental disorder
  • Remitted depressive disorder
  • Insufficient knowledge of German

Treatment and study plan

Two-week web-based self-help intervention based on principles of positive psychology

Behavioral

The web-based self-help intervention consists of 14 exercises based on the following positive psychology domains: personal strengths, pleasure, gratitude, engagement (flow, mindfulness) and positive relationships.

The (partly interactive) exercises are created to be implemented by the participants themselves without support of a therapist.

Before starting the intervention, the participants are told that they will receive a daily email with an instruction for a short exercise over the period of two weeks. The participants are instructed to complete the exercises every day and are told that they will be asked to evaluate these exercises at the next appointment (post-test, week 2)

Two-week web-based text messages containing fun facts

Behavioral

The web-based sham intervention consists of 14 text messages containing random interesting facts ("fun facts").

Before starting the sham intervention, the participants are told that they will receive a daily email with a text message to read every over the period of two weeks. The participants are instructed to read these text messages every day and are told that they will be asked to evaluate these exercises at the next appointment (post-test, week 2)

Primary outcomes

  1. Positive and Negative Affect Schedule for Children-Short Form (PANAS-C-SF)

    Time frame: Pre-test (week 0), post-test (week 2), follow-up (week 4)

    The PANAS is a self-report inventory to assess positive and negative affect (10 items for PA and 10 items for NA), rated on a 5-point response scale, with higher scores indicating more positive affect or negative affect. Participants will complete the PANAS at pre-, post-test and follow-up to determine change in negative and positive affect

  2. Beck Depression Inventory - Second Edition (BDI-II)

    Time frame: Pre-test (week 0), post-test (week 2), follow-up (week 4)

    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. Participants will complete the BDI-II at pre-, post-test and follow-up to determine change in depressive symptoms

  3. Perceived Stress Scale (PSS-10)

    Time frame: Pre-test (week 0), post-test (week 2), follow-up (week 4)

    The PSS-10 is a self-report inventory to assess perceived stress, rated on a 5-point response scale, with higher scores indicating more perceived stress. Participants will complete the PSS-10 at pre-, post-test and follow-up to determine change in perceived stress

Secondary outcomes

  1. Adherence

    Time frame: Post-test (week 2)

    A self-report inventory, designed by the investigators, to measure the rate of adherence to the intervention

  2. Acceptance

    Time frame: Post-test (week 2)

    A self-report inventory, designed by the investigators, to measure the acceptability / appeal of the intervention

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Collaborators

  • Prof. Otto Beisheim Foundation

Registry information

Official study title

Evaluation of a Web-based Self-help Intervention Based on Principles of Positive Psychology Promoting Mental Health in Adolescents

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 6, 2021
Registry last updated
Jan 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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