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

NCT ID: NCT06385457

Last Updated: 2025-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

4910 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-06

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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

Conditions

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Mental Health Issue Well-Being Adolescents Young Adults Online Intervention Internet-Based Intervention Randomized Controlled Trial Body Dissatisfaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be recruited via social media, and randomly allocated to an intervention group (receiving information about Mindhelper.dk) or a control group (no information about Mindhelper.dk). Outcomes, will be measured at 2-, 6-, and 12-weeks post-randomization and analysed using the intention-to-treat approach.

According to the investigators' power calculation, at least 3,142 participants (1,571 in each group) are required at follow-up 2 weeks after the randomization (primary endpoint). In the test phase, the investigators retrieved a response proportion of 64% for this follow-up survey. Assuming a similar retention proportion the investigators aim to include 4910 participants at baseline. The proportion of participants responding to the follow-up surveys will be regularly reviewed to evaluate if the assumption on retention is correct or if the number of participants included should be increased or decreased.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators
The participants are partly masked. The control group will be masked; however, the intervention group will not be masked.

There is no care provider nor outcome assessor as all measures are self-reported and collected through online questionnaires.

Analyses of data and interpretation of results will be done masked.

Study Groups

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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.

Group Type EXPERIMENTAL

Mindhelper- A national youth mental health promotion website

Intervention Type BEHAVIORAL

Mindhelper is an open-access, digital self-directed mental health service that provides information, self-help tools and guidance to young people in Denmark.

Control group

The control group does not receive information about Mindhelper.dk, until after completion of the last follow-up questionnaire.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

-Aged 15-25
Minimum Eligible Age

15 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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TrygFonden, Denmark

INDUSTRY

Sponsor Role collaborator

Danske Regioner

OTHER

Sponsor Role collaborator

Jascha Fonden

OTHER

Sponsor Role collaborator

Region of Southern Denmark

OTHER

Sponsor Role collaborator

University of Southern Denmark

OTHER

Sponsor Role lead

Responsible Party

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Anna Paldam Folker

Head of Research, Professor, ph.d.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anna P Folker

Role: PRINCIPAL_INVESTIGATOR

National Institute of Public Health, University of Southern Denmark

Locations

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National Institute of Public Health (NIPH), University of Southern Denmark

Copenhagen, Copenhagen K, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Sofie H Hoffmann

Role: CONTACT

65 50 77 34 ext. +45

Lau C Thygesen

Role: CONTACT

65 50 77 71 ext. +45

Facility Contacts

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Sofie H Hoffmann

Role: primary

65 50 77 34 ext. +45

Lau C Thygesen

Role: backup

65 50 77 71 ext. +45

References

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Hoffmann SH, Paldam Folker A, Buskbjerg M, Paldam Folker M, Huber Jezek A, Lyngso Svarta D, Nielsen Solvhoj I, Thygesen L. Potential of Online Recruitment Among 15-25-Year Olds: Feasibility Randomized Controlled Trial. JMIR Form Res. 2022 May 25;6(5):e35874. doi: 10.2196/35874.

Reference Type BACKGROUND
PMID: 35612877 (View on PubMed)

Hoffmann SH, Kusier AO, Mairey IP, Folker AP, Thygesen LC. A Self-Guided Digital Mental Health Promotion Service Targeting Young People: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Sep 10;14:e73736. doi: 10.2196/73736.

Reference Type DERIVED
PMID: 40929726 (View on PubMed)

Other Identifiers

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24-2933

Identifier Type: -

Identifier Source: org_study_id

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