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 de junho de 2026 atualizado por: 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.
Visão geral do estudo
Status
Ainda não está recrutando
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
1000
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Kim Rand, PhD
- Número de telefone: 004740220366
- E-mail: kim.rand@ahus.no
Estude backup de contato
- Nome: Julia M Delor, PhD
- E-mail: julia.menichetti.delor@ahus.no
Locais de estudo
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Akershus
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Lørenskog, Akershus, Noruega, 1978
- Akershus University Hospital
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Contato:
- Kim Rand, PhD
- Número de telefone: 004740220366
- E-mail: kim.rand@ahus.no
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-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: 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.
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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.
Outros nomes:
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Comparador Ativo: 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.
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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.
Outros nomes:
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Comparador de 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.
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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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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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)
Prazo: From baseline (first day) until first post-intervention measurement (approximately 2 weeks)
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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).
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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)
Prazo: From baseline (first day) until first post-intervention follow-up (approximately 14 days)
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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)
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From baseline (first day) until first post-intervention follow-up (approximately 14 days)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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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)
Prazo: 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
|
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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)
Prazo: 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)
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Baseline to 3 month follow up, baseline to 6 months
|
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QALY accrual as measured using the EQ-5D-5L
Prazo: From baseline to 6 month follow up, linear interpolation
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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
Prazo: Baseline to post-treatment, 3 months, 6 months
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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.
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Baseline to post-treatment, 3 months, 6 months
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Mean Client Satisfaction Questionnaire-8 (CSQ) score post-intervention
Prazo: Post-intervention follow up (approximately day 14)
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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
Prazo: Post-intervention follow-up (approximately day 14)
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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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Julia M Delor, PhD, University Hospital, Akershus
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
15 de agosto de 2027
Conclusão Primária (Estimado)
31 de março de 2028
Conclusão do estudo (Estimado)
31 de março de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
1 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
1 de junho de 2026
Primeira postagem (Real)
4 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
4 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
1 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- SDAM_UTV532429
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano 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.
Prazo de Compartilhamento de 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 de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
- ANALYTIC_CODE
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .