An interventional study of Tankevirus and Grubl in Anxiety and Depression, sponsored by University Hospital, Akershus. Not yet recruiting at 1 site in Norway. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by University Hospital, Akershus · Not applicable, Interventional, and Treatment
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.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →University Hospital, Akershus is the lead sponsor of 125 studies on the registry; 28 are open to participants now.
Compared within Depression, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Tankevirus is a brief, CBT-based psychoeducative app running over approximately 2 weeks. Content is provided in the form of videos with daily reminders. The version to be used is an update of the existing app, expected to be complete by May 2027.
Other: Tankevirus
Grubl is a brief, metacognitive therapy based psychoeducative app running over approximately 2 weeks. Content is provided in the form of videos with daily reminders.
Other: Grubl
The placebo / sham app will have structural elements largely matching Tankevirus and Grubl; providing a programme of approximately 2 weeks. The app will present information on attention control training as a method for reducing problems with anxiety and depression. While attention control training can be effective for this purpose, the app will only provide very brief (a few minutes) of daily attention-demanding miniature games, that are expected to have zero or negligible impact on anxiety or depression. Full details on the placebo arm setup including screenshots etc. will be provided alongside the registered report publication.
Other: Placebo Application
Tankevirus is a brief, CBT-based psychoeducative app running over approximately 2 weeks. Content is provided in the form of videos with daily reminders. The version to be used is an update of the existing app, expected to be complete by May 2027.
Also known as: CBT-based self-help, Psychoeducation
Grubl is a brief, metacognitive therapy based psychoeducative app running over approximately 2 weeks. Content is provided in the form of videos with daily reminders.
Also known as: Self-help, Meta-cognitive therapy, Psychoeducation
The placebo / sham app will have structural elements largely matching Tankevirus and Grubl; providing a programme of approximately 2 weeks. The app will present information on attention control training as a method for reducing problems with anxiety and depression. While attention control training can be effective for this purpose, the app will only provide very brief (a few minutes) of daily attention-demanding miniature games, that are expected to have zero or negligible impact on anxiety or depression. Full details on the placebo arm setup including screenshots etc. will be provided alongside the registered report publication.
Also known as: Sham application
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)
The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item self-report scale developed to assess the severity of generalized anxiety disorder symptoms. It is widely used as a brief screening and outcome measure for anxiety in clinical practice and research. Measured at baseline, postintervention, and at 3- and 6-month follow-up. Items are scored 0 to 3 (total score 0 to 21). Cutoffs: 5 (mild), 10 (moderate), and 15 (severe). Change measured in participants reporting at least mild problems at baseline (GAD-7 \>= 5).
Time frame: From baseline (first day) until first post-intervention measurement (approximately 2 weeks)
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)
The Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-report instrument designed to assess depressive symptom severity based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria. It is a commonly used tool for depression screening and monitoring treatment outcomes in research and practice. Items are scored 0 to 3 (total score 0 to 27). Cutoffs: 5 (mild), 10 (moderate), 15 (moderately severe), and 20 (severe). Measured at baseline, postintervention, and at 3- and 6-month follow-up. Change measured in participants reporting at least mild symptoms at baseline (PHQ-9 \>=5)
Time frame: From baseline (first day) until first post-intervention follow-up (approximately 14 days)
Change in anxiety symptoms measured by the GAD-7 total score between baseline and 3 months, 6 months, among participants reporting problems with anxiety at baseline (baseline GAD-7 score >= 5)
The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item self-report scale developed to assess the severity of generalized anxiety disorder symptoms. It is widely used as a brief screening and outcome measure for anxiety in clinical practice and research. Measured at baseline, postintervention, and at 3- and 6-month follow-up. Items are scored 0 to 3 (total score 0 to 21). Cutoffs: 5 (mild), 10 (moderate), and 15 (severe). Change measured in participants reporting at least mild problems at baseline (GAD-7 \>= 5).
Time frame: Baseline to 3 month follow up, baseline to 6 month follow-up
Change in depression symptoms measured by the PHQ-9 total score between baseline and 3 months, 6 months, among participants reporting problems with anxiety at baseline (baseline PHQ-9 score >= 5)
The Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-report instrument designed to assess depressive symptom severity based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria. It is a commonly used tool for depression screening and monitoring treatment outcomes in research and practice. Items are scored 0 to 3 (total score 0 to 27). Cutoffs: 5 (mild), 10 (moderate), 15 (moderately severe), and 20 (severe). Measured at baseline, postintervention, and at 3- and 6-month follow-up. Change measured in participants reporting at least mild symptoms at baseline (PHQ-9 \>=5)
Time frame: Baseline to 3 month follow up, baseline to 6 months
QALY accrual as measured using the EQ-5D-5L
The EQ-5D-5L, developed by the EuroQol Group, measures HRQoL across 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) with 5 severity levels. It is extensively used in clinical trials, health economics, and QALY calculations. The Norwegian EQ-5D-5L tariff will be used. Delta QALYs will be calculated using interpolation over the 6-month observation period. Utility values for QALY calculation will use the Norwegian EQ-5D-5L value set. Measured at baseline, postintervention, and at 3- and 6-month follow-up.
Time frame: From baseline to 6 month follow up, linear interpolation
Change in functional impairment as measured using the WSAS
The Work and Social Adjustment Scale (WSAS) is a 5-item self-report scale developed to measure functional impairment attributable to a specific health problem across work, home management, social and private leisure activities, and relationships. It is frequently used to quantify disability in mental health research and evaluate treatment impact. Scores range from 0 to 40; higher scores indicate greater impairment. A score \>20 indicates moderately severe or worse impairment. Measured at baseline, postintervention, and at 3- and 6-month follow-up.
Time frame: Baseline to post-treatment, 3 months, 6 months
Mean Client Satisfaction Questionnaire-8 (CSQ) score post-intervention
The Client Satisfaction Questionnaire-8 (CSQ-8) is an 8-item self-report tool assessing client satisfaction with health and mental health services. It is widely applied in service evaluation and clinical trials to measure acceptability and perceived benefit of interventions. Administered at postintervention follow-up only.
Time frame: Post-intervention follow up (approximately day 14)
Mean System Usability Scale (SUS) score post-intervention
The System Usability Scale (SUS) is a 10-item Likert-scale questionnaire providing composite app usability score (0-100). The SUS has become an industry standard for app assessment. Administered at postintervention follow-up only.
Time frame: Post-intervention follow-up (approximately day 14)
Health Care Resource Use (HCRU) post-baseline, at 3 and 6 months
HCRU will be based on retrospective use of health care between measurements. Unit costs for Norwegian health care services will be sourced from the Norwegian Medical Products Agency.
Time frame: Baseline to 6 months
Plan to share: Yes — Full anonymized data will be made available following main publication. The study oversight committee will go over the dataset in detail to ensure that anonymity is preserved.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: Following publication of the main registered report manuscript, the protocol, SAP, analytical code, and anonymized IPD will be made available on a public repository.
Start is estimated for Aug 2027; primary completion for Mar 2028, 7 months later.
Of 3,468 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 7 months is below that.
Counting every sponsor, half of 3,566 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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