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Clinical Trials/NCT04650906
NCT04650906CompletedNot Applicable

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

University of Southern Denmark2 sites in 1 country560 target enrollmentStarted: November 2, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
560
Locations
2
Primary Endpoint
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.

Study Overview

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.

Detailed Description

Introduction Up to 25% of young people in Denmark do not enjoy their daily lives; they report increasing levels of stress, loneliness, sleep problems, and symptoms of anxiety and depression. Online mental health promotion has the potential to address some of the mental health needs of young people. However, the evidence-base for the effectiveness of online mental health promotion is still sparse. The Mindhelper Study will evaluate the effectiveness of the most comprehensive online youth mental health promotion website in Denmark; Mindhelper.dk. Mindhelper is targeted at young people in need of mental health promotion. This is a broad group that encompasses three different subgroups of young people; (i) those who need advice on various well-being issues such as dealing with peer-pressure or a broken heart, (ii) those with early signs of mental health problems, and (iii) those who have mental disorders (or other chronic diseases) who need help to promote their mental health and well-being - such as dealing with loneliness, sleep problems, or structuring their everyday life - alongside more specialized treatment.

The Mindhelper website is designed as a first step in a stepped-care approach to organize the mental health system. At the website, young people are provided trusted mental health information and tools to improve their mental health and well-being. The feasibility study described in this document is the first step of the evaluation.

Feasibility study 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.

While online recruitment may seem feasible and useful for recruiting subpopulations that are normally difficult to include in intervention studies, such as young people with mental health problems, only few studies have been undertaken. Some studies have examined the feasibility of online recruitment among the general population, couples planning pregnancy, patients with urinary incontinence, and people with drug or alcohol dependencies. The lessons learned from these studies are that the costs per participant are lower, compared to offline recruitment methods; that it is possible to reach populations who are otherwise challenging to enroll because they have sensitive health concerns; and that the recruited persons are younger, more highly educated, and have poorer self-rated health and higher self-efficacy than representative samples. Concerns have been raised that internet- based studies may be particularly prone to selection bias. However, a Danish study of reproductive women showed that internet-based cohorts were not more prone to selection bias than other recruitment methods, which has also been shown among smokers recruited by email or online for a smoking cessation trial.

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Single (Participant)

Masking Description

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.

Eligibility Criteria

Ages
15 Years to 25 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •aged 15-25
  • •Danish speaking
  • •Danish residency

Exclusion Criteria

  • Not provided

Arms & Interventions

Intervention group

Experimental

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

Intervention: Mindhelper - a national youth mental health promotion website (Behavioral)

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.

Outcomes

Primary Outcomes

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.

Time Frame: Up to 2 months

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

The timeframe for recruiting people for the study through networking sites

Time Frame: Up to 2 months

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

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%)?

Time Frame: Up to 2 months

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.

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

Time Frame: Up to 2 months

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Anna Paldam Folker

Head of Research, Associate professor, PhD

University of Southern Denmark

Study Sites (2)

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