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

University Hospital, Akershus

Status: Begins enrollment in a year or more

Conditions: Depression; Anxiety

Treatments: Other: Tankevirus; Other: Grubl; Other: Placebo Application

Study type: Interventional

Funder types: Other

Identifiers

NCT07627204

SDAM_UTV532429

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,000 participants in 3 patient groups, including a placebo group

Tankevirus app

Active Comparator group

Description:

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.

Treatment:

Other: Tankevirus

Grubl app

Active Comparator group

Description:

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.

Treatment:

Other: Grubl

Placebo app

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo Application