The Effects of Mindhelper on Young People's Well-being, Psychological Functioning, and Intentions to Help-seeking

Mental Health Issue Clinical Trial

Official title:

The Mindhelper Study- The Effects of Online, Self-directed Mental Health Promotion on Young People's Well-being, Psychological Functioning, and Intentions to Help-seeking

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06385457
• Other study ID #: 24-2933
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 29, 2024
• Est. completion date: January 31, 2025

Study information

• Verified date: April 2024
• Source: University of Southern Denmark
• Contact: Sofie H Hoffmann
• Phone: 65 50 77 34
• Email: sohh[@]sdu.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study the investigators will evaluate the effectiveness of Mindhelper.dk, which is the most comprehensive online youth mental health promotion service in Denmark. A minimum of 9,426 young people aged 15 to 25 will be recruited through social media and invited to participate in the study. When responding to the baseline questionnaire participants will be randomized to either the intervention or control group. The intervention group will receive information about Mindhelper.dk and inspiration on how to use Mindhelper through text-messages during the study period. The control group does not receive information about Mindhelper.dk, until after completion of the last follow-up questionnaire. Three follow-up questionnaires will then be sent to the participants 2 weeks, 6 weeks and 12 weeks after randomization. The investigators expect a small, positive effect on participants well-being and psychological functioning in intervention groups as compared to the control group.

Description:

See the attached project description

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 9426
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 25 Years

Eligibility

• Aged 15-25
• Ability to respond to questionnaire in Danish

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Mindhelper- A national youth mental health promotion website
Mindhelper is an open-access, digital self-directed mental health service that provides information, self-help tools and guidance to young people in Denmark.

Locations

Country	Name	City	State
Denmark	National Institute of Public Health (NIPH), University of Southern Denmark	Copenhagen	Copenhagen K

Sponsors (5)

Lead Sponsor	Collaborator
University of Southern Denmark	Centre for Digital Psychiatry, Mental Health Services in the Region of Southern Denmark, Danske Regioner, Jascha Fonden, TrygFonden, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Primary	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	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.
Secondary	Intentions to help-seeking	As the investigators have developed the questions used to assess intentions to 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), 2 weeks (T2), 6 weeks(T3) and 12 weeks (T4) after randomization.