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Completed

NCT Number: NCT06385457

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

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.

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Key information

Conditions

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

Age range

15 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Copenhagen, Copenhagen K, 1455, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

-Aged 15-25

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • Danske Regioner
  • Jascha Fonden
  • Region of Southern Denmark
  • TrygFonden, Denmark

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 26, 2024
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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