Mental Health IssueNCT06385457
The Effects of Mindhelper.dk: a Self-guided Digital Mental Health Promotion Service Targeting Young People
A study testing Mindhelper- A national youth mental health promotion website in people with Mental Health Issue and Well-Being, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
In a two-armed randomized controlled trial 15-25-year-olds will be recruited via social media to evaluate the effectiveness of Mindhelper.dk; a Danish self-guided, digital, mental health service offering information, self-help tools, and guidance to young people. Read more about this study
- Who is it for?
- Ages 15 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue, Well-Being, Adolescents
- What is being tested?
- Mindhelper- A national youth mental health promotion website
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,355 participants
- Where
- 1 siteDenmark
- Study dates
- 7 Jan 2025to 20 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
-Aged 15-25
Trial locations and contacts
1 site in 1 country.
Denmark1 site
National Institute of Public Health (NIPH), University of Southern Denmark
Copenhagen, Copenhagen K, 1455
About this study
In a two-armed randomized controlled trial 15-25-year-olds will be recruited via social media to evaluate the effectiveness of Mindhelper.dk; a Danish self-guided, digital, mental health service offering information, self-help tools, and guidance to young people. Participants will be randomly allocated to an intervention group (receiving information about Mindhelper.dk) or a control group (no information about Mindhelper.dk). Outcomes, including well-being (WHO5), psychological functioning (SWEMWBS), help-seeking intentions, and body appreciation (2-item BAS-2SF), will be measured at 2-, 6-, and 12-weeks post-randomization and analyzed using the intention-to-treat approach. Qualitative interviews with intervention group participants will provide complementary insights, and a cost-effectiveness analysis will also be conducted.
Read the detailed description
A study protocol will be made publicly accessible upon acceptance for publication in a suitable journal
- Conditions
- Mental Health Issue, Well-Being, Adolescents, Young Adults, Online Intervention, Internet-Based Intervention
- Being tested
- Mindhelper- A national youth mental health promotion website
- Keywords
- Self-guided, Prevention, Well-being, eHealth, Promotion, Adolescents, Young adults, Body Appreciation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindhelper- A national youth mental health promotion websiteBehavioural
Mindhelper is an open-access, digital self-directed mental health service that provides information, self-help tools and guidance to young people in Denmark.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group will receive information about Mindhelper.dk and inspiration on how to use Mindhelper through text-messages during the study period. Receives: Behavioral: Mindhelper- A national youth mental health promotion website |
| Control group | No intervention | The control group does not receive information about Mindhelper.dk, until after completion of the last follow-up questionnaire. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and randomization(T1), 2 weeks (T2), 6 weeks(T3) and 12 weeks (T4) after randomization.
Secondary outcomes (1)
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.
Measured: Baseline and randomization(T1), 2 weeks (T2), 6 weeks(T3) and 12 weeks (T4) after randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start7 Jan 2025
- Primary completion20 May 2026
- Study completion20 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be recruited via social media, and randomly allocated to an intervention group (receiving information about Mindhelper.dk) or a control group (no information about Mindhelper.dk). Outcomes, will be measured at 2-, 6-, and 12-weeks post-randomization and analysed using the intention-to-treat approach. According to the investigators' power calculation, at least 3,142 participants (1,571 in each group) are required at follow-up 2 weeks after the randomization (primary endpoint). In the test phase, the investigators retrieved a response proportion of 64% for this follow-up survey. Assuming a similar retention proportion the investigators aim to include 4910 participants at baseline. The proportion of participants responding to the follow-up surveys will be regularly reviewed to evaluate if the assumption on retention is correct or if the number of participants included should be increased or decreased.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 4,355 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- TrygFonden, Denmark, Danske Regioner, Jascha Fonden, Region of Southern Denmark
- Responsible party
- Sponsor
- Investigators
- Anna P Folker, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06385457
- Sponsor's protocol ID
- 24-2933
- Status last verified
- Jul 2026
- First submitted
- 15 Apr 2024
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It will be possible to share IPD, but no plans of this have yet been made.
Publications
Hoffmann SH, Kusier AO, Mairey IP, Folker AP, Thygesen LC. A Self-Guided Digital Mental Health Promotion Service Targeting Young People: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Sep 10;14:e73736. doi: 10.2196/73736.
PubMed 40929726
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Mindhelper.dk: a Self-guided Digital Mental Health Promotion Service Targeting Young People
- ClinicalTrials.gov ID
- NCT06385457
- Acronym / sponsor ID
- 24-2933
- Conditions
- Mental Health Issue, Well-Being, Adolescents, Young Adults, Online Intervention, Internet-Based Intervention
- Keywords
- Self-guided, Prevention, Well-being, eHealth, Promotion, Adolescents, Young adults, Body Appreciation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,355 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- TrygFonden, Denmark, Danske Regioner, Jascha Fonden, Region of Southern Denmark
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- 20 May 2026 (actual)
- Study completion
- 20 May 2026 (actual)
- First posted
- 26 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In a two-armed randomized controlled trial 15-25-year-olds will be recruited via social media to evaluate the effectiveness of Mindhelper.dk; a Danish self-guided, digital, mental health service offering information, self-help tools, and guidance to young people. Participants will be randomly allocated to an intervention group (receiving information about Mindhelper.dk) or a control group (no information about Mindhelper.dk). Outcomes, including well-being (WHO5), psychological functioning (SWEMWBS), help-seeking intentions, and body appreciation (2-item BAS-2SF), will be measured at 2-, 6-, and 12-weeks post-randomization and analyzed using the intention-to-treat approach. Qualitative interviews with intervention group participants will provide complementary insights, and a cost-effectiveness analysis will also be conducted.
Detailed description
A study protocol will be made publicly accessible upon acceptance for publication in a suitable journal
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Participants will be recruited via social media, and randomly allocated to an intervention group (receiving information about Mindhelper.dk) or a control group (no information about Mindhelper.dk). Outcomes, will be measured at 2-, 6-, and 12-weeks post-randomization and analysed using the intention-to-treat approach. According to the investigators' power calculation, at least 3,142 participants (1,571 in each group) are required at follow-up 2 weeks after the randomization (primary endpoint). In the test phase, the investigators retrieved a response proportion of 64% for this follow-up survey. Assuming a similar retention proportion the investigators aim to include 4910 participants at baseline. The proportion of participants responding to the follow-up surveys will be regularly reviewed to evaluate if the assumption on retention is correct or if the number of participants included should be increased or decreased.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Mindhelper- A national youth mental health promotion websiteThe intervention group will receive information about Mindhelper.dk and inspiration on how to use Mindhelper through text-messages during the study period. |
| Control group | No intervention | –The control group does not receive information about Mindhelper.dk, until after completion of the last follow-up questionnaire. |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindhelper- A national youth mental health promotion websiteMindhelper is an open-access, digital self-directed mental health service that provides information, self-help tools and guidance to young people in Denmark. | Behavioural | Intervention group |
Primary outcome
General well-being measure by "The Well-Being Index WHO-5" (WHO5)
Time frame: Baseline and randomization(T1), 2 weeks (T2), 6 weeks(T3) and 12 weeks (T4) after randomization.
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.
1 secondary outcome
Psychological functioning, measure by "The Short Warwick-Edinburgh Mental Well-Being Scale" (SWEMWBS).
Time frame: Baseline and randomization(T1), 2 weeks (T2), 6 weeks(T3) and 12 weeks (T4) after randomization.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Derived from this study: PubMed 40929726Hoffmann SH, Kusier AO, Mairey IP, Folker AP, Thygesen LC. A Self-Guided Digital Mental Health Promotion Service Targeting Young People: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Sep 10;14:e73736. doi: 10.2196/73736.
- Individual participant dataSharing planned: Yes. It will be possible to share IPD, but no plans of this have yet been made.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna P Folker principal investigator
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindhelper- A national youth mental health promotion website in people with Mental Health Issue and Well-Being, run by University of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General well-being measure by "The Well-Being Index WHO-5" (WHO5) (time frame: Baseline and randomization(T1), 2 weeks (T2), 6 weeks(T3) and 12 weeks (T4) after randomization.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06385457, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.