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 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
1000
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Kim Rand, PhD
- Telefonnummer: 004740220366
- E-post: kim.rand@ahus.no
Studer Kontakt Backup
- Navn: Julia M Delor, PhD
- E-post: julia.menichetti.delor@ahus.no
Studiesteder
-
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Akershus
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Lørenskog, Akershus, Norge, 1978
- Akershus University Hospital
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Ta kontakt med:
- Kim Rand, PhD
- Telefonnummer: 004740220366
- E-post: kim.rand@ahus.no
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / 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.
|
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 navn:
|
|
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.
|
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 navn:
|
|
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.
|
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 navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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)
|
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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)
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 |
Tiltaksbeskrivelse |
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.
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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
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 |
Tiltaksbeskrivelse |
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.
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Post-intervention follow up (approximately day 14)
|
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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.
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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
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.
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Baseline to 6 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Julia M Delor, PhD, University Hospital, Akershus
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
15. august 2027
Primær fullføring (Antatt)
31. mars 2028
Studiet fullført (Antatt)
31. mars 2028
Datoer for studieregistrering
Først innsendt
1. juni 2026
Først innsendt som oppfylte QC-kriteriene
1. juni 2026
Først lagt ut (Faktiske)
4. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
4. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
1. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SDAM_UTV532429
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (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 Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- ANALYTIC_CODE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
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Nei
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