A Feasibility Study for Evaluating the Effectiveness of Mindhelper - a National Youth Mental Health Promotion Website

NCT04650906 | Completed

• 1 other identifier: TrygFonden ID: 148711
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 2

Brief Summary

The feasibility study will investigate the potential of online recruitment for a randomized trial of the effectiveness of Mindhelper. Recruiting participants for intervention studies is increasingly difficult, as there are many commercials and research projects competing for people's attention. Thus, participation rates in research projects are generally declining. The widespread access to the internet, especially among adolescents, offers a new and attractive alternative strategy to recruit participants for intervention studies. The feasibility study will inform us whether it is possible to recruit young people with mental health problems who are not familiar with Mindhelper and then randomize them to use or not to use the website (block randomization). Furthermore, it is necessary to know whether it is possible to follow the two groups over time and assess relevant outcomes. We aim to answer the following questions:

• Is it possible to identify and recruit young persons (15-25 years of age) in need of mental health promotion via social networking sites such as Facebook.dk?
• How quickly is it possible to recruit people for the study through networking sites?
• Is it possible to ensure that the intervention group uses the Mindhelper website (\>75%) and minimize the likelihood that the control group uses it (\<25%)?
• Is it possible to follow the two groups to obtain information at first follow-up at one week (T2)? The results will inform the study design of the effectiveness study. If the feasibility study shows (i) that it is possible to recruit and randomize young people with mental health problems within a specified period, (ii) that both groups will follow their randomization into either the intervention or control group, and (iii) that it is possible to follow both groups to obtain follow-up data, then the main study will be conducted as an online recruited randomized effectiveness study (online RCT). If the feasibility study shows that the conditions are not ideal for achieving these goals, we will conduct a longitudinal panel study of Mindhelper users comparing different types of users.

Conditions

Mental Health Issue; Young Adult; Feasibility Studies; Randomized Controlled Trial; Internet-Based Intervention; Recruitment

Keywords

Online recruitment; Denmark

Outcome Measures

Primary Outcomes (4)

• Possibility to identify and recruit young persons (15-25 years of age) in need of mental health promotion via social networking sites such as Facebook.dk.

  Number of participants between 15-25 years of age in need of mental health promotion recruited via social networking sites such as Facebook.dk.

  Up to 2 months

• The timeframe for recruiting people for the study through networking sites

  Number of days for recruiting people for the study through networking sites

  Up to 2 months

• Possibility to ensure that the intervention group uses the Mindhelper website (>75%) and possibility to minimize the likelihood that the control group uses it (<25%)?

  Number of participants between 15-25 years of age assigned to the intervention group that uses Mindhelper and number of participants between 15-25 years of age assigned to the control group that does not use it.

  Up to 2 months

• Possibility to follow the two groups to obtain information at first follow-up at one week

  Number of participants in the intervention and control group who filled the follow-up questionnaire after one week.

  Up to 2 months

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention group gets information about the Mindhelper website and the control group does not get information about the Mindhelper website.

Behavioral: Mindhelper - a national youth mental health promotion website

Control group

NO INTERVENTION

The intervention group gets information about the Mindhelper website and the control group does not get information about the Mindhelper website.

Interventions

Mindhelper - a national youth mental health promotion website BEHAVIORAL

Mindhelper is a fully digital youth mental health service reaching out to a large number of young people when and where they need it, with full anonymity. Mindhelper was developed in 2014-2017 by Centre for Telepsychiatry in the Region of Southern Denmark in a partnership with four Danish municipalities. The development of the site was funded by the Danish foundation TrygFonden. The original idea behind the site was inspired by the Australian youth mental health promotion service ReachOut.com. The Mindhelper service was launched in September 2016. From January 2019 Mindhelper received permanent funding through a joint agreement between the five Danish Regions. Mindhelper is Denmark's most comprehensive youth mental health promotion website where young people can seek mental health information, advice, and self-help tools to improve their mental health and well-being. Since it was launched, the site has been very successful in attracting large numbers of visitors.

Intervention group

Eligibility Criteria

• Age: 15 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• aged 15-25
• Danish speaking
• Danish residency

You may not qualify if:

• None

Sponsors & Collaborators

• University of Southern Denmark: lead
• Region of Southern Denmark: collaborator
• VU University of Amsterdam: collaborator

Study Sites (2)

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

Copenhagen, 1455, Denmark

Location

Centre for Telepsychiatry (CTP), Mental Health Services in the Region of Southern Denmark

Odense, 5000, Denmark

Location

Related 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.

  PMID: 35612877 DERIVED

Study Officials

• Anna P Folker

  University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants are partly masked. The control group will be masked; however, the intervention group will not be masked. Other parties will not be masked.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research, Associate professor, PhD

Model Details: Participants are assigned to one of two or more groups in parallel for the duration of the study. Young people will be recruited through Facebook.dk and instragram, and block randomized to either use of Mindhelper (intervention group) or no information on Mindhelper (control group). At baseline participants will respond to a questionnaire on sociodemographic characteristics, and validated items related to well-being (primary outcome), psychological distress and daily functioning (secondary outcomes), and intentions and barriers to help-seeking (explorative outcomes). One week later participants will be asked to respond to a similar questionnaire. We will use 1:1 propensity score to increase comparability between the two groups and report the standardized difference on all baseline variables between high- and low-level users to evaluate whether the matching.

Study Record Dates

• First Submitted: October 23, 2020
• First Posted: December 3, 2020
• Study Start: November 2, 2020
• Primary Completion: December 18, 2020
• Study Completion: December 18, 2020
• Last Updated: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)