Mental Health Wellness 1OppNCT05211713
Opp - a Universal Mental Health Promoting Mobile Application for Adolescents
A study testing Opp in people with Mental Health Wellness 1, run by University of Tromso at 1 site in Norway.
Trial summary
The aim of the project is firstly, to develop an app-based mental health intervention for adolescents. Secondly, to evaluate the effect of this app. The overarching goal is to offer a low-threshold intervention, called Opp, that is easily accessible and free to use for all adolescents in Norway. Read more about this study
- Who is it for?
- Ages 13 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness 1
- What is being tested?
- Opp
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 399 participants
- Where
- 1 siteNorway
- Study dates
- 1 Aug 2022to 15 Nov 2023
- 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 13 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adolescents under 16 years whose guardians have given consent
Who cannot join
- severe developmental or cognitive challenges
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Opp: The Development and Evaluation of a Mental Health App for Adolescents
The aim of the project is firstly, to develop an app-based mental health intervention for adolescents. Secondly, to evaluate the effect of this app. The overarching goal is to offer a low-threshold intervention, called Opp, that is easily accessible and free to use for all adolescents in Norway.
Read the detailed description
The intervention "Opp" will be delivered through a mobile application. The overall goals of Opp are to 1) increase well-being and mental well-being, 2) increase knowledge about mental health, 3) increase coping skills to deal with stress, 4) increase help-seeking behavior, 5) increase self-esteem, 6) increase sleep quality and 7) reduce mental health problems.
To evaluate the mobile application two studies will be conducted: A user survey and an effectiveness study with a follow-up examination after about six weeks. The effectiveness study will be conducted as a randomized controlled trial with an intervention group and a waiting-list control group.
- Conditions
- Mental Health Wellness 1
- Being tested
- Opp
- Keywords
- Mental health promotion, Coping, Adolescents, Mobile application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OppDevice
Opp is a universal mental health promoting mobile application for adolescents aged 13-25 years.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group receiving Opp | Experimental | The effectiveness study will be conducted as a randomized controlled trial with an intervention group and a waiting-list control group. Data will be collected at baseline (T1, pre intervention) and after about six weeks of intervention (T2, post intervention). Receives: Device: Opp |
| Control group | No intervention | The waiting list control group will receive the intervention after study completion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in WHO-5 (WHO-Five Well-being Index)
WHO-5 (WHO, 1998): A five item self-report questionnaire assessing well-being on a six point scale.
Measured: Change from baseline to six weeks after intervention.
Change in SDQ (Strengths and Difficulties Questionnaire)
SDQ (Goodman, 1997): A 25 item self-report assessing mental health and psychosocial functioning in 11-17 years old adolescents on a three point scale.
Measured: Change from baseline to six weeks after intervention.
Secondary outcomes (4)
General Self-efficacy scale (GSE)
Resilience will be measured with the Norwegian version of the GSE (Røysamb, 1997; Schwarzer et al., 1995) which consists of 10 questions measured on a four-point scale.
Measured: Change from baseline to six weeks after intervention.
Help-seeking behavior
Two self-report items measuring if they sought help and who they sought help from.
Measured: Change from baseline to six weeks after intervention.
Self-liking and Competence Scale
Self-liking and Competence Scale (Silvera, Neilands, \& Perry, 2001; Tafarodi \& Swann, 2001): A 20 item self-report assessing self-liking and self-competence.
Measured: Change from baseline to six weeks after intervention.
Sleeping quality
Sleeping quality will be measured with six questions from the Bergen Child Study (Hysing, Harvey, Stormark, Pallesen, \& Sivertsen, 2018).
Measured: Change from baseline to six weeks after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start1 Aug 2022
- Primary completion15 Nov 2023
- Study completion15 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mental Health Wellness 1Studies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention and control group
- Masking
- None (open label)
- Enrolment
- 399 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tromso
- Sponsor type
- University, hospital or other
- Collaborators
- The Dam Foundation, Norwegian Council for Mental Health, Norwegian Directorate of Health
- Responsible party
- Sponsor
- Investigators
- Henriette Kyrrestad, PhD, Principal investigator, UiT The Arctic University of Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05211713
- Sponsor's protocol ID
- 279207
- Acronym
- Opp
- Status last verified
- May 2026
- First submitted
- 15 Dec 2021
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hogsdal H, Kaiser S, Mabille G, Martinussen M, Jakobsen R, Kyrrestad H. The effect of a universal mobile application on adolescents' mental health and well-being. Internet Interv. 2025 Feb 18;40:100814. doi: 10.1016/j.invent.2025.100814. eCollection 2025 Jun.
PubMed 40123821Kaiser S, Rye M, Jakobsen R, Martinussen M, Hogsdal H, Kyrrestad H. A Universal Mental Health-Promoting Mobile App for Adolescents: Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2023 Jan 11;12:e42119. doi: 10.2196/42119.
PubMed 36630167
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opp: The Development and Evaluation of a Mental Health App for Adolescents
- ClinicalTrials.gov ID
- NCT05211713
- Acronym / sponsor ID
- Opp / 279207
- Conditions
- Mental Health Wellness 1
- Keywords
- Mental health promotion, Coping, Adolescents, Mobile application
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 399 participants (actual)
- Lead sponsor
- University of TromsoUniversity, hospital or other
- Collaborators
- The Dam Foundation, Norwegian Council for Mental Health, Norwegian Directorate of Health
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 27 Jan 2022 (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.
The aim of the project is firstly, to develop an app-based mental health intervention for adolescents. Secondly, to evaluate the effect of this app. The overarching goal is to offer a low-threshold intervention, called Opp, that is easily accessible and free to use for all adolescents in Norway.
Detailed description
The intervention "Opp" will be delivered through a mobile application. The overall goals of Opp are to 1) increase well-being and mental well-being, 2) increase knowledge about mental health, 3) increase coping skills to deal with stress, 4) increase help-seeking behavior, 5) increase self-esteem, 6) increase sleep quality and 7) reduce mental health problems.
To evaluate the mobile application two studies will be conducted: A user survey and an effectiveness study with a follow-up examination after about six weeks. The effectiveness study will be conducted as a randomized controlled trial with an intervention group and a waiting-list control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention and control group
| Arm | Type | Receives |
|---|---|---|
| Intervention group receiving Opp | Experimental | Device: OppThe effectiveness study will be conducted as a randomized controlled trial with an intervention group and a waiting-list control group. Data will be collected at baseline (T1, pre intervention) and after about six weeks of intervention (T2, post intervention). |
| Control group | No intervention | –The waiting list control group will receive the intervention after study completion. |
Who may qualify
- Ages
- 13 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Adolescents under 16 years whose guardians have given consent
Key exclusion criteria (1 listed)
- severe developmental or cognitive challenges
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 |
|---|---|---|
| OppOpp is a universal mental health promoting mobile application for adolescents aged 13-25 years. | Device | Intervention group receiving Opp |
Primary outcome
Change in WHO-5 (WHO-Five Well-being Index)
Time frame: Change from baseline to six weeks after intervention.
WHO-5 (WHO, 1998): A five item self-report questionnaire assessing well-being on a six point scale.
Change in SDQ (Strengths and Difficulties Questionnaire)
Time frame: Change from baseline to six weeks after intervention.
SDQ (Goodman, 1997): A 25 item self-report assessing mental health and psychosocial functioning in 11-17 years old adolescents on a three point scale.
4 secondary outcomes
General Self-efficacy scale (GSE)
Time frame: Change from baseline to six weeks after intervention.
Help-seeking behavior
Time frame: Change from baseline to six weeks after intervention.
Self-liking and Competence Scale
Time frame: Change from baseline to six weeks after intervention.
Sleeping quality
Time frame: Change from baseline to six weeks after intervention.
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 11 May 2026.
- Results publication: PubMed 40123821Hogsdal H, Kaiser S, Mabille G, Martinussen M, Jakobsen R, Kyrrestad H. The effect of a universal mobile application on adolescents' mental health and well-being. Internet Interv. 2025 Feb 18;40:100814. doi: 10.1016/j.invent.2025.100814. eCollection 2025 Jun.
- Derived from this study: PubMed 36630167Kaiser S, Rye M, Jakobsen R, Martinussen M, Hogsdal H, Kyrrestad H. A Universal Mental Health-Promoting Mobile App for Adolescents: Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2023 Jan 11;12:e42119. doi: 10.2196/42119.
- HomepageLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Mental Health Wellness 1
Active, not recruiting
Future School of Comprehensive Well-Being
Learning, Comprehensive Wellbeing
Not yet recruiting
A Virtual Reality Program for Nursing Home Residents With Physical Disabilities
Older Adults Institutionalized in Residential Homes
RecruitingObservational study
Friends/Family of Individuals at Risk of Suicide Training Program
Caregiver, Caregiver Mental Health
Recruiting
GUT-FEELINGS: Using Citizen Science for Large-Scale Prebiotic Clinical Trials for Mental Wellness in Adults
Sleep Disturbance, Stress
Not yet recruitingPhase 1
A Study to Detect the Radioactivity of 14C-SEP-380135 in Urine and Feces in Healthy Male Adults
Schizophrenia
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.
Henriette Kyrrestad, PhD principal investigator
UiT The Arctic University of Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opp in people with Mental Health Wellness 1, run by University of Tromso at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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 11 May 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 Norway. 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?
Change in WHO-5 (WHO-Five Well-being Index) (time frame: Change from baseline to six weeks after intervention.). The study lists 2 primary outcomes in all. 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 NCT05211713, which also lists 2 linked publications.
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 11 May 2026.