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

NCT04650906 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 560

Last updated 2021-09-29

No results posted yet for this study

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

Interventions

BEHAVIORAL

Mindhelper - a national youth mental health promotion website

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.

Sponsors & Collaborators

  • Region of Southern Denmark

    collaborator OTHER
  • VU University of Amsterdam

    collaborator OTHER
  • University of Southern Denmark

    lead OTHER

Principal Investigators

  • Anna P Folker · University of Southern Denmark

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-02
Primary Completion
2020-12-18
Completion
2020-12-18

Countries

  • Denmark

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04650906 on ClinicalTrials.gov