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

Not Applicable

Recruiting

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

• Registration Number: NCT06385457
• Lead Sponsor: University of Southern Denmark

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

Study Timeline

• Study First Submitted: 2024-04-15
• Study First Submitted QC: 2024-04-23
• Study First Posted: 2024-04-26
• Study Start: 2025-01-06
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-13
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4910

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
General well-being measure by "The Well-Being Index WHO-5" (WHO5)	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 Outcome Measures

Name	Time	Method
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.	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.

Trial Locations

Locations (1)

National Institute of Public Health (NIPH), University of Southern Denmark; 🇩🇰 Copenhagen, Copenhagen K, Denmark