AnxietyMIND-APPNCT07627204
Mental Health INtervention With Digital APPlications (MIND-APP): Randomized Controlled Researcher Blinded Trial Evaluating the Effectiveness of the Tankevirus and Grubl Mental Health Apps
A study testing Tankevirus and Grubl in people with Anxiety and Depression, run by University Hospital, Akershus at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Anxiety, Depression
- What is being tested?
- Tankevirus and Grubl
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- 1 siteNorway
- Study dates
- 15 Aug 2027to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Julia M Delor, PhD contact
Norway1 site
Akershus University Hospital
Lørenskog, Akershus, 1978
Kim Rand, PhD, 004740220366, kim.rand@ahus.no
About this study
Official title: App-Based Mental Health Interventions for Anxiety and Depression: Protocol for the MIND-APP Randomized Controlled Trial
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.
- Conditions
- Anxiety, Depression
- Being tested
- Tankevirus, Grubl, Placebo Application
- Keywords
- Anxiety, Depression, Cognitive Behavioral Therapy, CBT, cost-effectiveness, digital health, metacognitive therapy, Norway, QALY, Application
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TankevirusOther
Also called CBT-based self-help, Psychoeducation
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.
GrublOther
Also called Self-help, Meta-cognitive therapy, 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.
Placebo ApplicationOther
Also called Sham application
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.
| Study group | Role | What they receive |
|---|---|---|
| Tankevirus app | Active comparator | 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. Receives: Other: Tankevirus |
| Grubl app | Active comparator | 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. Receives: Other: Grubl |
| Placebo app | Placebo comparator | 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. Receives: Other: Placebo Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: From baseline (first day) until first post-intervention follow-up (approximately 14 days)
Secondary outcomes (4)
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).
Measured: 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)
Measured: 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.
Measured: 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.
Measured: Baseline to post-treatment, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start15 Aug 2027 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
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 AnxietyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kim Rand, University Hospital, Akershus
- Investigators
- Julia M Delor, PhD, Principal investigator, University Hospital, Akershus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07627204
- Sponsor's protocol ID
- SDAM_UTV532429
- Acronym
- MIND-APP
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Rand K, Menichetti J, Wisloff T, Brorson HH. Effectiveness and Cost-Effectiveness of the Tankevirus and Grubl Mental Health Apps Compared With a Placebo App-Mental Health Intervention With Digital Applications (MIND-APP): Protocol for a Randomized Controlled Researcher-Blinded Trial. JMIR Res Protoc. 2026 Aug 10;15:e84096. doi: 10.2196/84096.
PubMed 42575499
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- App-Based Mental Health Interventions for Anxiety and Depression: Protocol for the MIND-APP Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07627204
- Acronym / sponsor ID
- MIND-APP / SDAM_UTV532429
- Conditions
- Anxiety, Depression
- Keywords
- Anxiety, Depression, Cognitive Behavioral Therapy, CBT, cost-effectiveness, digital health, metacognitive therapy, Norway
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Study start
- 15 Aug 2027 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 4 Jun 2026 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tankevirus app | Active comparator | Other: TankevirusTankevirus 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. |
| Grubl app | Active comparator | Other: GrublGrubl is a brief, metacognitive therapy based psychoeducative app running over approximately 2 weeks. Content is provided in the form of videos with daily reminders. |
| Placebo app | Placebo comparator | Other: Placebo ApplicationThe 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| TankevirusAlso: CBT-based self-help, PsychoeducationTankevirus 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 app |
| GrublAlso: Self-help, Meta-cognitive therapy, PsychoeducationGrubl 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 app |
| Placebo ApplicationAlso: Sham applicationThe 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 app |
Primary outcome
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)
Time frame: From baseline (first day) until first post-intervention measurement (approximately 2 weeks)
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).
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)
Time frame: From baseline (first day) until first post-intervention follow-up (approximately 14 days)
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)
4 secondary outcomes
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)
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)
Time frame: Baseline to 3 month follow up, baseline to 6 months
QALY accrual as measured using the EQ-5D-5L
Time frame: From baseline to 6 month follow up, linear interpolation
Change in functional impairment as measured using the WSAS
Time frame: Baseline to post-treatment, 3 months, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Derived from this study: PubMed 42575499Rand K, Menichetti J, Wisloff T, Brorson HH. Effectiveness and Cost-Effectiveness of the Tankevirus and Grubl Mental Health Apps Compared With a Placebo App-Mental Health Intervention With Digital Applications (MIND-APP): Protocol for a Randomized Controlled Researcher-Blinded Trial. JMIR Res Protoc. 2026 Aug 10;15:e84096. doi: 10.2196/84096.
- Individual participant dataSharing planned: 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.
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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.
Julia M Delor, PhD contact
Julia M Delor, PhD principal investigator
University Hospital, Akershus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tankevirus and Grubl in people with Anxiety and Depression, run by University Hospital, Akershus 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 6 inclusion and 5 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: opening soon, as of the sponsor's last update on 4 Jun 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kim Rand, PhD (004740220366, Kim.rand@ahus.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: From baseline (first day) until first post-intervention measurement (approximately 2 weeks)). 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 NCT07627204, 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 4 Jun 2026.