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 giugno 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
1000
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Kim Rand, PhD
- Numero di telefono: 004740220366
- Email: kim.rand@ahus.no
Backup dei contatti dello studio
- Nome: Julia M Delor, PhD
- Email: julia.menichetti.delor@ahus.no
Luoghi di studio
-
-
Akershus
-
Lørenskog, Akershus, Norvegia, 1978
- Akershus University Hospital
-
Contatto:
- Kim Rand, PhD
- Numero di telefono: 004740220366
- Email: kim.rand@ahus.no
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: 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.
Altri nomi:
|
|
Comparatore attivo: 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.
Altri nomi:
|
|
Comparatore 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.
|
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.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
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)
Lasso di tempo: 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)
Lasso di tempo: 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)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Mean Client Satisfaction Questionnaire-8 (CSQ) score post-intervention
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Julia M Delor, PhD, University Hospital, Akershus
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
15 agosto 2027
Completamento primario (Stimato)
31 marzo 2028
Completamento dello studio (Stimato)
31 marzo 2028
Date di iscrizione allo studio
Primo inviato
1 giugno 2026
Primo inviato che soddisfa i criteri di controllo qualità
1 giugno 2026
Primo Inserito (Effettivo)
4 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
4 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
1 giugno 2026
Ultimo verificato
1 giugno 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- SDAM_UTV532429
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano 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.
Periodo di condivisione 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.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
- CODICE_ANALITICO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .