Mental Health INtervention With Digital APPlications (MIND-APP): Randomized Controlled Researcher Blinded Trial Evaluating the Effectiveness of the Tankevirus and Grubl Mental Health Apps (MIND-APP)
1. června 2026 aktualizováno: Kim Rand, University Hospital, Akershus
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.
Přehled studie
Postavení
Zatím nenabíráme
Intervence / Léčba
Typ studie
Intervenční
Zápis (Odhadovaný)
1000
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Kim Rand, PhD
- Telefonní číslo: 004740220366
- E-mail: kim.rand@ahus.no
Studijní záloha kontaktů
- Jméno: Julia M Delor, PhD
- E-mail: julia.menichetti.delor@ahus.no
Studijní místa
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Akershus
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Lørenskog, Akershus, Norsko, 1978
- Akershus University Hospital
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Kontakt:
- Kim Rand, PhD
- Telefonní číslo: 004740220366
- E-mail: kim.rand@ahus.no
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Aktivní komparátor: Tankevirus app
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.
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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.
Ostatní jména:
|
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Aktivní komparátor: Grubl app
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.
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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.
Ostatní jména:
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Komparátor placeba: Placebo app
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.
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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.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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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)
Časové okno: From baseline (first day) until first post-intervention measurement (approximately 2 weeks)
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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).
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From baseline (first day) until first post-intervention measurement (approximately 2 weeks)
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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)
Časové okno: From baseline (first day) until first post-intervention follow-up (approximately 14 days)
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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)
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From baseline (first day) until first post-intervention follow-up (approximately 14 days)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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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)
Časové okno: Baseline to 3 month follow up, baseline to 6 month follow-up
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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).
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Baseline to 3 month follow up, baseline to 6 month follow-up
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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)
Časové okno: Baseline to 3 month follow up, baseline to 6 months
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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)
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Baseline to 3 month follow up, baseline to 6 months
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QALY accrual as measured using the EQ-5D-5L
Časové okno: From baseline to 6 month follow up, linear interpolation
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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.
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From baseline to 6 month follow up, linear interpolation
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Change in functional impairment as measured using the WSAS
Časové okno: Baseline to post-treatment, 3 months, 6 months
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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.
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Baseline to post-treatment, 3 months, 6 months
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Mean Client Satisfaction Questionnaire-8 (CSQ) score post-intervention
Časové okno: Post-intervention follow up (approximately day 14)
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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.
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Post-intervention follow up (approximately day 14)
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Mean System Usability Scale (SUS) score post-intervention
Časové okno: Post-intervention follow-up (approximately day 14)
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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.
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Post-intervention follow-up (approximately day 14)
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Health Care Resource Use (HCRU) post-baseline, at 3 and 6 months
Časové okno: Baseline to 6 months
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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.
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Baseline to 6 months
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Julia M Delor, PhD, University Hospital, Akershus
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
15. srpna 2027
Primární dokončení (Odhadovaný)
31. března 2028
Dokončení studie (Odhadovaný)
31. března 2028
Termíny zápisu do studia
První předloženo
1. června 2026
První předloženo, které splnilo kritéria kontroly kvality
1. června 2026
První zveřejněno (Aktuální)
4. června 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
4. června 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
1. června 2026
Naposledy ověřeno
1. června 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- SDAM_UTV532429
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu IPD
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.
Časový rámec sdílení IPD
Following publication of the main registered report manuscript, the protocol, SAP, analytical code, and anonymized IPD will be made available on a public repository.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ICF
- ANALYTIC_CODE
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
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