Clinical trial NCT06385457: The Effects of Mindhelper.dk: a Self-guided Digital Mental Health Promotion Service Targeting Young People
Official title: The Effects of Mindhelper.dk: a Self-guided Digital Mental Health Promotion Service Targeting Young People
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Health Issue
Well-Being
Adolescents
Young Adults
Online Intervention
Internet-Based Intervention
Randomized Controlled Trial
Body Dissatisfaction
Keywords: Self-guided
Prevention
Well-being
eHealth
Promotion
Adolescents
Young adults
Body Appreciation
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: TrygFonden, Denmark
name: Danske Regioner
name: Jascha Fonden
name: Region of Southern Denmark
First posted: 2024-04-26
Enrollment: 4910
Sex: ALL
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: OTHER

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.

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

Eligibility criteria: -Aged 15-25

Primary outcomes:
measure: General well-being measure by "The Well-Being Index WHO-5" (WHO5)
timeFrame: Baseline and randomization(T1), 2 weeks (T2), 6 weeks(T3) and 12 weeks (T4) after randomization.
Secondary outcomes:
measure: Psychological functioning, measure by "The Short Warwick-Edinburgh Mental Well-Being Scale" (SWEMWBS).
timeFrame: Baseline and randomization(T1), 2 weeks (T2), 6 weeks(T3) and 12 weeks (T4) after randomization.
Other outcomes:
measure: Intentions of help-seeking
timeFrame: Baseline and randomization(T1), 6 weeks(T3) and 12 weeks (T4) after randomization.
measure: Body Appreciation measured by the "2-items Short forms of the Body Appreciation Scale-2" (2-item BAS-2SF).
timeFrame: Baseline and randomization(T1), 2 weeks (T2), 6 weeks(T3) and 12 weeks (T4) after randomization.
Locations:
city: Copenhagen
country: Denmark
facility: National Institute of Public Health (NIPH), University of Southern Denmark
state: Copenhagen K
Study officials:
affiliation: National Institute of Public Health, University of Southern Denmark
name: Anna P Folker
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.