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 juin 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
1000
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Kim Rand, PhD
- Numéro de téléphone: 004740220366
- E-mail: kim.rand@ahus.no
Sauvegarde des contacts de l'étude
- Nom: Julia M Delor, PhD
- E-mail: julia.menichetti.delor@ahus.no
Lieux d'étude
-
-
Akershus
-
Lørenskog, Akershus, Norvège, 1978
- Akershus University Hospital
-
Contact:
- Kim Rand, PhD
- Numéro de téléphone: 004740220366
- E-mail: kim.rand@ahus.no
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: 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.
Autres noms:
|
|
Comparateur actif: 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.
Autres noms:
|
|
Comparateur 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.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
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)
Délai: 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)
Délai: 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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Mean Client Satisfaction Questionnaire-8 (CSQ) score post-intervention
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Julia M Delor, PhD, University Hospital, Akershus
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
15 août 2027
Achèvement primaire (Estimé)
31 mars 2028
Achèvement de l'étude (Estimé)
31 mars 2028
Dates d'inscription aux études
Première soumission
1 juin 2026
Première soumission répondant aux critères de contrôle qualité
1 juin 2026
Première publication (Réel)
4 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
4 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
1 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- SDAM_UTV532429
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime 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.
Délai de partage 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.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
- ANALYTIC_CODE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .