The Effects of Mindhelper.dk: a Self-guided Digital Mental Health Promotion Service Targeting Young People

May 1, 2026 updated by: University of Southern Denmark
In a two-armed randomized controlled trial 15-25-year-olds will be recruited via social media to evaluate the effectiveness of Mindhelper.dk; a Danish self-guided, digital, mental health service offering information, self-help tools, and guidance to young people. Participants will be randomly allocated to an intervention group (receiving information about Mindhelper.dk) or a control group (no information about Mindhelper.dk). Outcomes, including well-being (WHO5), psychological functioning (SWEMWBS), help-seeking intentions, and body appreciation (2-item BAS-2SF), will be measured at 2-, 6-, and 12-weeks post-randomization and analyzed using the intention-to-treat approach. Qualitative interviews with intervention group participants will provide complementary insights, and a cost-effectiveness analysis will also be conducted.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

A study protocol will be made publicly accessible upon acceptance for publication in a suitable journal

Study Type

Interventional

Enrollment (Estimated)

4910

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Copenhagen K
      • Copenhagen, Copenhagen K, Denmark, 1455
        • National Institute of Public Health (NIPH), University of Southern Denmark

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

-Aged 15-25

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
The intervention group will receive information about Mindhelper.dk and inspiration on how to use Mindhelper through text-messages during the study period.
Behavioral: Mindhelper- A national youth mental health promotion website
Mindhelper is an open-access, digital self-directed mental health service that provides information, self-help tools and guidance to young people in Denmark.
No Intervention: Control group
The control group does not receive information about Mindhelper.dk, until after completion of the last follow-up questionnaire.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
General well-being measure by "The Well-Being Index WHO-5" (WHO5)
Time Frame: Baseline and randomization(T1), 2 weeks (T2), 6 weeks(T3) and 12 weeks (T4) after randomization.

The WHO5 scores range between 0 and 100. The higher score, the higher level of well-being.

The effects of Mindhelper on well-being are measured through surveys disseminated to the study participants. The primary assessment of effect is conducted at T2.
Baseline and randomization(T1), 2 weeks (T2), 6 weeks(T3) and 12 weeks (T4) after randomization.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychological functioning, measure by "The Short Warwick-Edinburgh Mental Well-Being Scale" (SWEMWBS).
Time Frame: Baseline and randomization(T1), 2 weeks (T2), 6 weeks(T3) and 12 weeks (T4) after randomization.

The SWEMWBS scores range from 7 to 35, and higher scores indicate higher levels of mental wellbeing.

The effects of Mindhelper on psychological functioning are measured through surveys disseminated to the study participants. The primary assessment of effect is conducted at T2.
Baseline and randomization(T1), 2 weeks (T2), 6 weeks(T3) and 12 weeks (T4) after randomization.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Appreciation measured by the "2-items Short forms of the Body Appreciation Scale-2" (2-item BAS-2SF).
Time Frame: Baseline and randomization(T1), 2 weeks (T2), 6 weeks(T3) and 12 weeks (T4) after randomization.

The BAS-2SF uses a 5-point Likert scale for responses, ranging from 1 (Never) to 5 (Always), thus for 2-item BAS-2SF the score ranges from 2 to 10. Higher scores indicate greater body appreciation.

The effects of Mindhelper on body appreciation are measured through surveys disseminated to the study participants. The primary assessment of effect is conduct at T2.
Baseline and randomization(T1), 2 weeks (T2), 6 weeks(T3) and 12 weeks (T4) after randomization.
Intentions of help-seeking
Time Frame: Baseline and randomization(T1), 6 weeks(T3) and 12 weeks (T4) after randomization.

As the investigators have developed the questions used to assess intentions of help-seeking no validated ranging of score exists.

The effects of Mindhelper on intentions to help-seeking are measured through surveys disseminated to the study participants. The primary assessment of effect is conduct at T3.
Baseline and randomization(T1), 6 weeks(T3) and 12 weeks (T4) after randomization.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern Denmark

Collaborators

TrygFonden, Denmark
Region of Southern Denmark
Danske Regioner
Jascha Fonden

Investigators

  • Principal Investigator: Anna P Folker, University of Southern Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2025

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

April 15, 2024

First Submitted That Met QC Criteria

April 23, 2024

First Posted (Actual)

April 26, 2024

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 24-2933

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

It will be possible to share IPD, but no plans of this have yet been made.

IPD Sharing Time Frame

Before end of data collection

IPD Sharing Access Criteria

Will be published in open repositories

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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