DepressionNCT04994470
Web-based Self-help Intervention for Adolescents With Acute or Remitted Major Depressive Disorder
A study testing Two-week web-based self-help intervention based on principles of positive psychology and Two-week web-based text messages containing fun facts in people with Depression and Depressive Disorder, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Depression, Depressive Disorder, Depressive Symptoms
- What is being tested?
- Two-week web-based self-help intervention based on principles of positive psychology and Two-week web-based text messages containing fun facts
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- 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
- 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
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: Evaluation of a Web-based Self-help Intervention Based on Principals of Positive Psychology for Adolescents With Acute or Remitted Major Depressive Disorder
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.
Read the 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.
- Being tested
- Two-week web-based self-help intervention based on principles of positive psychology, Two-week web-based text messages containing fun facts
- Keywords
- Depression, Adolescence, Youth, Web-based Intervention, Self-help, Positive Psychology, Depressive Symptoms, Treatment, Positive Thinking
- Medical subject headings
- Depression, Depressive Disorder, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two-week web-based self-help intervention based on principles of positive psychologyBehavioural
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 factsBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Web-based intervention group | Experimental | Two-week web-based intervention Receives: Behavioral: Two-week web-based self-help intervention based on principles of positive psychology |
| Web-based control group | Sham comparator | Two-week web-based sham comparator Receives: Behavioral: Two-week web-based text messages containing fun facts |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Pre-test (week 0), post-test (week 2), follow-up (week 4)
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
Measured: Pre-test (week 0), post-test (week 2), follow-up (week 4)
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.
Measured: Pre-test (week 0), post-test (week 2), follow-up (week 4)
Secondary outcomes (2)
Adherence
A self-report inventory, designed by the investigators, to measure the rate of adherence to the intervention
Measured: Post-test (week 2)
Acceptance
: A self-report inventory, designed by the investigators, to measure the acceptability / appeal of the intervention
Measured: Post-test (week 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- 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.
- Other trials for DepressionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to two 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
- NCT04994470
- Sponsor's protocol ID
- 20114
- Status last verified
- Jan 2023
- First submitted
- 30 Jul 2021
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04994470
- Acronym / sponsor ID
- 20114
- Keywords
- Depression, Adolescence, Youth, Web-based Intervention, Self-help, Positive Psychology, Depressive Symptoms, Treatment
- 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
- 6 Aug 2021 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants are assigned to two groups in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| Web-based intervention group | Experimental | Behavioral: Two-week web-based self-help intervention based on principles of positive psychologyTwo-week web-based intervention |
| Web-based control group | Sham comparator | Behavioral: Two-week web-based text messages containing fun factsTwo-week web-based sham comparator |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Two-week web-based self-help intervention based on principles of positive psychologyThe 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). | Behavioural | Web-based intervention group |
| Two-week web-based text messages containing fun factsThe 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). | Behavioural | Web-based control group |
Primary outcome
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
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
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.
2 secondary outcomes
Adherence
Time frame: Post-test (week 2)
Acceptance
Time frame: Post-test (week 2)
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 25 Jan 2023.
- 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 Two-week web-based self-help intervention based on principles of positive psychology and Two-week web-based text messages containing fun facts in people with Depression and Depressive Disorder, 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 2 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 25 Jan 2023. 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. Some participants in this study may receive a placebo. 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?
Beck Depression Inventory - Second Edition (BDI-II) (time frame: Pre-test (week 0), post-test (week 2), follow-up (week 4)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jan 2023.