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

NCT06385457 | Active Not Recruiting

• 1 other identifier: 24-2933
• Study Type: interventional
• Target: 4,910
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Self-guided; Prevention; Well-being; eHealth; Promotion; Adolescents; Young adults; Body Appreciation

Outcome Measures

Primary Outcomes (1)

• General well-being measure by "The Well-Being Index WHO-5" (WHO5)

  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 Outcomes (1)

• Psychological functioning, measure by "The Short Warwick-Edinburgh Mental Well-Being Scale" (SWEMWBS).

  Baseline and randomization(T1), 2 weeks (T2), 6 weeks(T3) and 12 weeks (T4) after randomization.

Other Outcomes (2)

• Intentions of help-seeking

  Baseline and randomization(T1), 6 weeks(T3) and 12 weeks (T4) after randomization.

• Body Appreciation measured by the "2-items Short forms of the Body Appreciation Scale-2" (2-item BAS-2SF).

  Baseline and randomization(T1), 2 weeks (T2), 6 weeks(T3) and 12 weeks (T4) after randomization.

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

Mindhelper- A national youth mental health promotion website 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.

Intervention group

Eligibility Criteria

• Age: 15 Years - 25 Years
• Gender Eligibility Details: Men, women, and others
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

-Aged 15-25

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• TrygFonden, Denmark: collaborator
• Danske Regioner: collaborator
• Jascha Fonden: collaborator
• Region of Southern Denmark: collaborator
• University of Southern Denmark: lead

Study Sites (1)

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

Copenhagen, Copenhagen K, 1455, Denmark

Location

Related Publications (2)

• 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.

  PMID: 35612877 BACKGROUND

• 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.

  PMID: 40929726 DERIVED

Study Officials

• Anna P Folker

  University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 26, 2024
• Study Start: January 7, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Before end of data collection
• Access Criteria: Will be published in open repositories

Locations

DK (1)