App-Based Mental Health Interventions for Anxiety and Depression: Protocol for the MIND-APP Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants are automatically randomized to the relevant app setting in the app. Participants are not blinded to the arm to which they are assigned, but are not informed as to the other arms. All three arms record identical data. Allocation remains blinded until after analyses are complete.
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究者
Kim Rand
Senior Researcher
University Hospital, Akershus