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

NCT07627204 | Not Yet Recruiting

• 1 other identifier: SDAM_UTV532429
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression; Anxiety

Keywords

Anxiety; Depression; Cognitive Behavioral Therapy; CBT; cost-effectiveness; digital health; metacognitive therapy; Norway; QALY; Application

Outcome Measures

Primary Outcomes (2)

• 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)

  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)

  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)

Secondary Outcomes (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)

  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)

  Baseline to 3 month follow up, baseline to 6 months

• QALY accrual as measured using the EQ-5D-5L

  From baseline to 6 month follow up, linear interpolation

• Change in functional impairment as measured using the WSAS

  Baseline to post-treatment, 3 months, 6 months

Other Outcomes (3)

• Mean Client Satisfaction Questionnaire-8 (CSQ) score post-intervention

  Post-intervention follow up (approximately day 14)

• Mean System Usability Scale (SUS) score post-intervention

  Post-intervention follow-up (approximately day 14)

• Health Care Resource Use (HCRU) post-baseline, at 3 and 6 months

  Baseline to 6 months

Study Arms (3)

Tankevirus app

ACTIVE COMPARATOR

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.

Other: Tankevirus

Grubl app

ACTIVE COMPARATOR

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.

Other: Grubl

Placebo app

PLACEBO COMPARATOR

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.

Other: Placebo Application

Interventions

Tankevirus OTHER

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.

Also known as: CBT-based self-help, Psychoeducation

Tankevirus app

Grubl OTHER

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.

Also known as: Self-help, Meta-cognitive therapy, Psychoeducation

Grubl app

Placebo Application OTHER

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.

Also known as: Sham application

Placebo app

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Akershus: lead

Study Sites (1)

Akershus University Hospital

Lørenskog, Akershus, 1978, Norway

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Julia M Delor, PhD

  University Hospital, Akershus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kim Rand, PhD

CONTACT

004740220366; Kim.rand@ahus.no

Julia M Delor, PhD

CONTACT

julia.menichetti.delor@ahus.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 4, 2026
• Study Start (Estimated): August 15, 2027
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: June 4, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Following publication of the main registered report manuscript, the protocol, SAP, analytical code, and anonymized IPD will be made available on a public repository.

Locations

NO (1)