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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)

2026年6月1日 更新者：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.

調査の概要

状態

まだ募集していません

条件

介入・治療

研究の種類

介入

入学 (推定)

1000

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前：Kim Rand, PhD
  • 電話番号：004740220366
  • メール：kim.rand@ahus.no

研究連絡先のバックアップ

研究場所

  • ノルウェー
    • Akershus
      • Lørenskog、Akershus、ノルウェー、1978
        • Akershus University Hospital
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子
  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：トリプル

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ：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.
他の：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.
他の名前：
  • 心理教育
  • CBT-based self-help
アクティブコンパレータ：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.
他の：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.
他の名前：
  • 心理教育
  • 自助
  • Meta-cognitive therapy
プラセボコンパレーター：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.
他の：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 depression. Full details on the placebo arm setup including screenshots etc. will be provided alongside the registered report publication.
他の名前：
  • Sham application

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
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)
時間枠：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)
時間枠：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)

二次結果の測定

結果測定
メジャーの説明
時間枠
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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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

その他の成果指標

結果測定
メジャーの説明
時間枠
Mean Client Satisfaction Questionnaire-8 (CSQ) score post-intervention
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

University Hospital, Akershus

捜査官

  • 主任研究者：Julia M Delor, PhD、University Hospital, Akershus

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2027年8月15日

一次修了 (推定)

2028年3月31日

研究の完了 (推定)

2028年3月31日

試験登録日

最初に提出

2026年6月1日

QC基準を満たした最初の提出物

2026年6月1日

最初の投稿 (実際)

2026年6月4日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月4日

QC基準を満たした最後の更新が送信されました

2026年6月1日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • SDAM_UTV532429

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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 共有時間枠

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 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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