Mental Health INtervention With Digital APPlications (MIND-APP): Randomized Controlled Researcher Blinded Trial Evaluating the Effectiveness of the Tankevirus and Grubl Mental Health Apps

Официальное название

App-Based Mental Health Interventions for Anxiety and Depression: Protocol for the MIND-APP Randomized Controlled Trial

Обзор

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.

Вмешательства

• Другое 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.
• Другое 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.
• Другое 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 d

Первичные конечные точки

• 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) [Срок оценки: 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) [Срок оценки: From baseline (first day) until first post-intervention follow-up (approximately 14 days)]

Вторичные конечные точки (4)

• 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) [Срок оценки: 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) [Срок оценки: Baseline to 3 month follow up, baseline to 6 months]
• QALY accrual as measured using the EQ-5D-5L [Срок оценки: From baseline to 6 month follow up, linear interpolation]
• Change in functional impairment as measured using the WSAS [Срок оценки: Baseline to post-treatment, 3 months, 6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Норвегия · 1 центр

• Akershus University Hospital — Lørenskog

Идентификаторы

NCT: NCT07627204 · SDAM_UTV532429

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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