NCT04994496

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 6, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2022

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

1.3 years

First QC Date

July 30, 2021

Last Update Submit

January 23, 2023

Conditions

Keywords

Mental HealthAdolescenceYouthPreventionPositive PsychologySelf-helpWeb-based Intervention

Outcome Measures

Primary Outcomes (3)

  • 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

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

  • 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

    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

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

Secondary Outcomes (2)

  • Adherence

    Post-test (week 2)

  • Acceptance

    Post-test (week 2)

Study Arms (2)

Web-based intervention group

EXPERIMENTAL

Two-week web-based intervention group

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

Behavioral: Two-week web-based text messages containing fun facts

Interventions

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 intervention group

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)

Web-based control group

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Intelligence quotient (IQ) of ≥ 80

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Munich, Bavaria, 80336, Germany

Location

Related Publications (1)

  • Kaubisch S, Kloek M, Primbs R, Iglhaut L, Piechaczek CE, Keim PM, Feldmann L, Schulte-Korne G, Greimel E. A web-based approach to adolescent mental health: Randomized controlled trial of a brief Positive Psychology intervention. Internet Interv. 2025 Sep 12;42:100872. doi: 10.1016/j.invent.2025.100872. eCollection 2025 Dec.

MeSH Terms

Conditions

Psychological Well-BeingDepression

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorBehavioral Symptoms

Study Officials

  • Gerd Schulte-Körne, Professor

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants are not aware of the assigned intervention group
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants are assigned to two groups in parallel for the duration of the study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoctoral Researcher

Study Record Dates

First Submitted

July 30, 2021

First Posted

August 6, 2021

Study Start

January 4, 2021

Primary Completion

May 2, 2022

Study Completion

May 2, 2022

Last Updated

January 25, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

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

Locations