Web-based Self-help Intervention for Adolescents With Acute or Remitted Major Depressive Disorder

NCT ID: NCT04994470

Last Updated: 2023-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-04
• Study Completion Date: 2022-05-02

Brief Summary

This study aims to evaluate the feasibility and effectiveness of a web-based self-help intervention in adolescents with acute or remitted major depressive disorder. 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.

Detailed Description

Youth with major depressive disorder often have little knowledge about depression, and do not receive an appropriate treatment. Besides little 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 information and services as a complementary strategy to mental health treatment, such as knowledge about depression and self-help strategies, are urgently needed for young people seeking help for depression.

We developed a website, which provides evidence-based information about depression (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 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. In addition, the provided self-help exercises might be a complementary approach to professional treatments of depression.

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 1. A study focusing on target group 2 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 and alleviate negative affect and depressive symptoms in adolescents with acute or remitted depressive disorder.

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

Conditions

Depression; Depressive Disorder; Depressive Symptoms; Depressive Disorder, Major

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Web-based intervention group

Two-week web-based intervention

Group Type: EXPERIMENTAL

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

Intervention Type: 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).

Web-based control group

Two-week web-based sham comparator

Group Type: SHAM_COMPARATOR

Two-week web-based text messages containing fun facts

Intervention Type: BEHAVIORAL

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

Before starting the sham comparator, 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).

Interventions

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

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).

Intervention Type: BEHAVIORAL

Two-week web-based text messages containing fun facts

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

Before starting the sham comparator, 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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Current or remitted diagnosis of MD (ICD-10 diagnoses F32.0; F32.1; F32.2, F33.0, F33.1, F.33.2)
• 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prof. Otto Beisheim Foundation

OTHER

Sponsor Role: collaborator

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role: lead

Responsible Party

Ellen Greimel

Postdoctoral Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gerd Schulte-Körne, Professor

Role: STUDY_DIRECTOR

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

Locations

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

Munich, Bavaria, Germany

Countries

Germany

Other Identifiers

20114

Identifier Type: -

Identifier Source: org_study_id