Web-based Self-help Intervention for Adolescents With Acute or Remitted Major Depressive Disorder
Primary Purpose
Depression, Depressive Disorder, Depressive Symptoms
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Two-week web-based self-help intervention based on principles of positive psychology
Two-week web-based text messages containing fun facts
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Depression, Adolescence, Youth, Web-based Intervention, Self-help, Positive Psychology, Depressive Symptoms, Treatment, Positive Thinking
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
Sites / Locations
- Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital Munich, Munich, Germany
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Web-based intervention group
Web-based control group
Arm Description
Two-week web-based intervention
Two-week web-based sham comparator
Outcomes
Primary Outcome Measures
Beck Depression Inventory - Second Edition (BDI-II)
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
Positive and Negative Affect Schedule for Children-Short Form (PANAS-C-SF)
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
Perceived Stress Scale (PSS-10)
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 Outcome Measures
Adherence
A self-report inventory, designed by the investigators, to measure the rate of adherence to the intervention
Acceptance
: A self-report inventory, designed by the investigators, to measure the acceptability / appeal of the intervention
Full Information
NCT ID
NCT04994470
First Posted
July 30, 2021
Last Updated
January 23, 2023
Sponsor
Ludwig-Maximilians - University of Munich
Collaborators
Beisheim Foundation (Germany)
1. Study Identification
Unique Protocol Identification Number
NCT04994470
Brief Title
Web-based Self-help Intervention for Adolescents With Acute or Remitted Major Depressive Disorder
Official Title
Evaluation of a Web-based Self-help Intervention Based on Principals of Positive Psychology for Adolescents With Acute or Remitted Major Depressive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
January 4, 2021 (Actual)
Primary Completion Date
May 2, 2022 (Actual)
Study Completion Date
May 2, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ludwig-Maximilians - University of Munich
Collaborators
Beisheim Foundation (Germany)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Depressive Disorder, Depressive Symptoms, Depressive Disorder, Major
Keywords
Depression, Adolescence, Youth, Web-based Intervention, Self-help, Positive Psychology, Depressive Symptoms, Treatment, Positive Thinking
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are assigned to two groups in parallel for the duration of the study
Masking
Participant
Masking Description
Participants are not aware of the assigned intervention group
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Web-based intervention group
Arm Type
Experimental
Arm Description
Two-week web-based intervention
Arm Title
Web-based control group
Arm Type
Sham Comparator
Arm Description
Two-week web-based sham comparator
Intervention Type
Behavioral
Intervention Name(s)
Two-week web-based self-help intervention based on principles of positive psychology
Intervention Description
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
Intervention Name(s)
Two-week web-based text messages containing fun facts
Intervention Description
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).
Primary Outcome Measure Information:
Title
Beck Depression Inventory - Second Edition (BDI-II)
Description
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
Time Frame
Pre-test (week 0), post-test (week 2), follow-up (week 4)
Title
Positive and Negative Affect Schedule for Children-Short Form (PANAS-C-SF)
Description
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
Time Frame
Pre-test (week 0), post-test (week 2), follow-up (week 4)
Title
Perceived Stress Scale (PSS-10)
Description
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.
Time Frame
Pre-test (week 0), post-test (week 2), follow-up (week 4)
Secondary Outcome Measure Information:
Title
Adherence
Description
A self-report inventory, designed by the investigators, to measure the rate of adherence to the intervention
Time Frame
Post-test (week 2)
Title
Acceptance
Description
: A self-report inventory, designed by the investigators, to measure the acceptability / appeal of the intervention
Time Frame
Post-test (week 2)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerd Schulte-Körne, Professor
Organizational Affiliation
Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital Munich
Official's Role
Study Director
Facility Information:
Facility Name
Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital Munich, Munich, Germany
City
Munich
State/Province
Bavaria
ZIP/Postal Code
80336
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
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.
Learn more about this trial
Web-based Self-help Intervention for Adolescents With Acute or Remitted Major Depressive Disorder
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