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| Name | Class |
|---|---|
| TrygFonden, Denmark | INDUSTRY |
| Danske Regioner | OTHER |
| Jascha Fonden | OTHER |
| Region of Southern Denmark |
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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.
A study protocol will be made publicly accessible upon acceptance for publication in a suitable journal
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Control group | No Intervention | The control group does not receive information about Mindhelper.dk, until after completion of the last follow-up questionnaire. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Psychological functioning, measure by "The Short Warwick-Edinburgh Mental Well-Being Scale" (SWEMWBS). | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Intentions of help-seeking | 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. |
-Aged 15-25
Men, women, and others
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| Name | Affiliation | Role |
|---|---|---|
| Anna P Folker | University of Southern Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute of Public Health (NIPH), University of Southern Denmark | Copenhagen | Copenhagen K | 1455 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35612877 | Background | 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. | |
| 40929726 | Derived | 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. |
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It will be possible to share IPD, but no plans of this have yet been made.
Before end of data collection
Will be published in open repositories
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| OTHER |
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.
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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.
| Body Appreciation measured by the "2-items Short forms of the Body Appreciation Scale-2" (2-item BAS-2SF). | 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. |