Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04650906 |
| Other study ID # |
TrygFonden ID: 148711 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 2, 2020 |
| Est. completion date |
December 18, 2020 |
Study information
| Verified date |
September 2021 |
| Source |
University of Southern Denmark |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
Young people will be recruited through Facebook.dk and Instagram. The first phase of the
recruitment will target young people that are in need of mental health promotion, therefore
adds for the study will be targeted individuals that have liked or are members of sites on
Facebook concerning mental health e.g. the initiative against loneliness Ventilen. Further
the initial recruitment will target young people living in the area of Odense, as this is
where CTP is placed and therefore will ease the collection of web history. If the
investigators do not succeed recruiting all participants with this rather narrow strategy,
the investigators will further include the area in and around Copenhagen, as web history may
as well be collected at CFI. Hereafter, the recruitment strategy will be widened, to
guarantee an uptake of 120 participants. The constant inclusion criteria will be young people
aged 15-25, Danish speaking, and Danish residency.
The feasibility study investigates the potential of online recruitment through social media
for a randomized trial of the effectiveness of Mindhelper.
The investigators aim to answer the following questions:
- Is it possible to identify and recruit young persons (15-25 years of age) 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, the investigators will conduct a
longitudinal panel study of Mindhelper users comparing different types of users (see
description below).
As this is a feasibility study, a formal sample size calculation will not be performed. The
investigators plan to include approximately 120 persons (60 in the intervention group and 60
in the control group), which is slightly higher than the standard number. A subsample of the
participants will further be invited to the Centre for Telepsychiatry, Mental Health Services
in the Region of Southern Denmark, to let a researcher code their web history related to the
participants use of Mindhelper. The researcher may view their web history for the past week,
but will only code activity related to Mindhelper, which as well is the only information that
will be saved and applied in further analyses. This data will also be used to validate survey
responses of use of the website, and asses if self-reported questions on online behavior is a
valid measure for actual online behavior. Participant who visit the Centre for Telepsychiatry
will be given a gift card for the cinema (200 DKK) in appreciation for their participation in
the study. Among participants responding to both surveys, there will be a lottery were a few
participants will win a gift for the cinema (200 DKK). Participants that are given gifts,
will be informed that tax regulations may apply, and that it is their responsibility to
inform SKAT of the gift. The financial compensation for participants is given independent of
their responds and web history, which give no reason to believe that the gifts may impact the
study in any other way, than to promote participations and full follow-up.
Ethics The design of The Mindhelper Study is guided by the CONSORT Statement and the STROBE
guidelines. The study will be conducted in accordance with the Danish Council for Independent
Research's ethical guidelines. The study will be registered and approved by the University of
Southern Denmark in accordance with the Data Protection Regulation and comply with the
General Data Protection Regulation (GDPR) (EU) 2016/679. All participants will receive
comprehensive information about the purpose of the project and terms of participation. The
participants will be asked to give their written consent to participate in the research. The
trial will also be registered by ClinicalTrials.gov which is a database of privately and
publicly funded clinical provided by the U.S. National Library of Medicine
(https://www.clinicaltrials.gov/). The investigators will publish the results of the
feasibility study regardless of the outcome.
The study focuses on mental wellbeing and health promotion, not on mental illness nor
psychiatric diagnoses, and thus participants may be enrolled independently of their mental
health. Broad scales of mental health will primarily be applied in the survey. When sensitive
topics as bullying and self-harm occur, it will be related to participants use of Mindhelper,
and participants will never be asked for details in this relation, neither will any of the
question be on an individual level. However, if a participant respond that he/she e.g. has
experienced bullying, or is lonely, he/she will be encouraged to contact organizations able
to support him/her (e.g. Børnetelefonen og Ventilen) and contact information will be provided
directly in the survey. Participants are eligible for participation if they are between 15
and 25 years of age. According to Danish law children can give consent based on their
maturity and children of the aged of 13 years and above can give consent for use of their
personal data. However, participants will be encouraged to talk to their parents or other
adults if on doubt of participation.
