Mental Health INtervention With Digital APPlications (MIND-APP): Randomized Controlled Researcher… (NCT07627204) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Mental Health INtervention With Digital APPlications (MIND-APP): Randomized Controlled Researcher Blinded Trial Evaluating the Effectiveness of the Tankevirus and Grubl Mental Health Apps
Norway1,000 participantsStarted 2027-08-15
Plain-language summary
The MIND-APP trial is a 3-arm randomized controlled trial (1:1:1 allocation) conducted fully remotely via a bespoke smartphone research platform. A total of 1000 Norwegian residents aged 16 years or older with mild to moderate symptoms of anxiety and/or depression will be recruited through national digital outreach. Coprimary outcomes are changes in anxiety (Generalized Anxiety Disorder-7) and depression (Patient Health Questionnaire-9) scores from baseline to postintervention (2-4 weeks). Secondary outcomes include health-related quality of life (EQ-5D-5L), quality-adjusted life years accrued over 6 months, functional impairment (Work and Social Adjustment Scale), health care resource use, and adverse events. Incremental cost-effectiveness ratios for Tankevirus and Grubl relative to placebo will be estimated from the perspective of public health services.
Who can participate
Age range
16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults and adolescents aged 16 years or older (16 is the minimum age of consent without parental approval for participation in research in Norway. Inclusion of individuals aged younger than 18 years will be highlighted in the ethical review.)
* Residing in Norway
* Access to a compatible smartphone (iOS or Android)
* Reporting mild to moderately severe symptoms of anxiety and/or depression (Patient Health Questionnaire-9 \[PHQ-9\] score ≥5 and/or Generalized Anxiety Disorder-7 \[GAD-7\] ≥5)
* Able to read Norwegian and use Norwegian to a sufficient level
* Able and willing to provide consent for the study prior to participation
Exclusion Criteria:
* PHQ-9 score ≥20 (severe depression)
* Active suicidal ideation (PHQ-9 item 9 score ≥2)
* Have ever required hospitalization for mental illness or are currently taking antipsychotic or other psychotropic medications
* Current engagement in psychological treatment
* Report having used Tankevirus or Grubl apps in the past
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The difference in GAD-7 score for anxiety symptoms between baseline and post-intervention for participants with mild to moderately severe self-reported problems with anxiety at baseline (GAD-7 score => 5)
Timeframe: From baseline (first day) until first post-intervention measurement (approximately 2 weeks)
2
The difference in PHQ-9 score for depression symptoms between baseline and post-intervention for participants with mild to moderately severe self-reported problems with anxiety at baseline (PHQ-9 score => 5)
Timeframe: From baseline (first day) until first post-intervention follow-up (approximately 14 days)