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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. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

1000

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv 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.
Andet: 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.
Andre navne:
  • Psykoedukation
  • CBT-based self-help
Aktiv 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.
Andet: 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.
Andre navne:
  • Psykoedukation
  • Selvhjælp
  • Meta-cognitive therapy
Placebo komparator: 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.
Andet: 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.
Andre navne:
  • Sham application

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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)
Tidsramme: 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)
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean Client Satisfaction Questionnaire-8 (CSQ) score post-intervention
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospital, Akershus

Efterforskere

  • Ledende efterforsker: Julia M Delor, PhD, University Hospital, Akershus

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. august 2027

Primær færdiggørelse (Anslået)

31. marts 2028

Studieafslutning (Anslået)

31. marts 2028

Datoer for studieregistrering

Først indsendt

1. juni 2026

Først indsendt, der opfyldte QC-kriterier

1. juni 2026

Først opslået (Faktiske)

4. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SDAM_UTV532429

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingstidsramme

Following publication of the main registered report manuscript, the protocol, SAP, analytical code, and anonymized IPD will be made available on a public repository.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

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