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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 czerwca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

1000

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Norwegia
    • Akershus
      • Lørenskog, Akershus, Norwegia, 1978
        • Akershus University Hospital
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko
  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Potroić

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: 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.
Inny: Tankevirus
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.
Inne nazwy:
  • Psychoedukacja
  • CBT-based self-help
Aktywny komparator: 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.
Inny: Grubl
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.
Inne nazwy:
  • Psychoedukacja
  • Samopomoc
  • Meta-cognitive therapy
Komparator placebo: 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.
Inny: Placebo 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.
Inne nazwy:
  • Sham application

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
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)
Ramy czasowe: 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).
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)
Ramy czasowe: 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)
From baseline (first day) until first post-intervention follow-up (approximately 14 days)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
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)
Ramy czasowe: Baseline to 3 month follow up, baseline to 6 month follow-up
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).
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)
Ramy czasowe: Baseline to 3 month follow up, baseline to 6 months
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)
Baseline to 3 month follow up, baseline to 6 months
QALY accrual as measured using the EQ-5D-5L
Ramy czasowe: From baseline to 6 month follow up, linear interpolation
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.
From baseline to 6 month follow up, linear interpolation
Change in functional impairment as measured using the WSAS
Ramy czasowe: Baseline to post-treatment, 3 months, 6 months
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.
Baseline to post-treatment, 3 months, 6 months

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Mean Client Satisfaction Questionnaire-8 (CSQ) score post-intervention
Ramy czasowe: Post-intervention follow up (approximately day 14)
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.
Post-intervention follow up (approximately day 14)
Mean System Usability Scale (SUS) score post-intervention
Ramy czasowe: Post-intervention follow-up (approximately day 14)
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.
Post-intervention follow-up (approximately day 14)
Health Care Resource Use (HCRU) post-baseline, at 3 and 6 months
Ramy czasowe: Baseline to 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.
Baseline to 6 months

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University Hospital, Akershus

Śledczy

  • Główny śledczy: Julia M Delor, PhD, University Hospital, Akershus

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

15 sierpnia 2027

Zakończenie podstawowe (Szacowany)

31 marca 2028

Ukończenie studiów (Szacowany)

31 marca 2028

Daty rejestracji na studia

Pierwszy przesłany

1 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

1 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

4 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

4 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

1 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • SDAM_UTV532429

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu 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.

Ramy czasowe udostępniania 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 informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY
  • ICF
  • ANALITYCZNY_KOD

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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