Clinical trial Recruiting at 1 site Interventional Ages 13 to 16

Modi: a therapist-guided digital CBT app for teens with mild to moderate anxiety

Official title: Effektiviteten av en Digital Mestringsapp for Ungdommer Med Mild Til Moderat Angst

Run by Haukeland University Hospital · NCT06531980 · Data updated 2026-11-12

This trial will try a therapist-guided chatbot app (Modi) for 13–16-year-olds in Bergen with mild to moderate anxiety to see if it reduces anxiety symptoms and improves daily functioning.

More Anxiety trials

Quick facts

Study typeInterventional
Ages13 Years to 16 Years
SexAll
Enrollment128 (estimated)
SponsorHaukeland University Hospital
Academic / other
Locations1 site (Bergen, Vestland)
StatusRecruiting
StartedJanuary 16, 2025
Main results expectedAugust 31, 2026
Study endsDecember 30, 2026
Registry record updatedAugust 28, 2025
Trial IDNCT06531980 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal participants are 13–16-year-olds living in Bergen who can read Norwegian, report mild to moderate anxiety that interferes with daily life, and are not currently in other psychological treatment.

Probably not a fit

Patients with severe depression, active suicide risk, OCD, psychosis, substance abuse, autism spectrum disorder, anxiety mainly due to bullying, extensive recent school absence, or those already receiving psychological treatment may not be helped by this intervention or are excluded.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled trial will enroll 128 adolescents aged 13–16 in Bergen and randomize them to an 8-week therapist-guided, rule-based chatbot CBT program (Modi) or to treatment as usual provided by the Child and Family Help Center. Participants will use the mobile app training program over eight weeks while researchers measure changes in anxiety symptoms and functional level using standardized questionnaires such as the RCADS-25 at baseline and follow-up. Key eligibility includes Norwegian-reading residents of Bergen with mild to moderate anxiety who are not currently receiving other psychological treatments and who do not have conditions requiring immediate specialized care. The trial is conducted at the Research Centre for Digital Mental Health Services at Haukeland University Hospital in collaboration with Bergen kommune.

Why it matters

Potential benefit: If effective, the app could reduce anxiety symptoms and improve daily functioning while offering a more accessible, lower-intensity treatment option for adolescents.

How similar studies have gone: Previous digital CBT programs for adolescent anxiety have shown moderate benefit, but therapist-guided rule-based chatbot interventions remain relatively novel with limited evidence.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Ages 13-16
* Resides in Bergen
* Completed RCADS-25
* Reports "yes" to both questions:
* Do you have anxiety symptoms? Do you often feel stressed, scared, worried, or feel it in your body (e.g., stomach pain, heart palpitations, breathing problems, sweating, dizziness)?
* Do anxiety symptoms prevent you from doing things you want or need to do (e.g., meeting new people, giving presentations at school, going to sleepovers, going to the shopping center)? Or do you spend so much time worrying that it affects your daily life? Can read Norwegian

Exclusion Criteria:

* Currently receiving other psychological treatment
* Immediate need for other psychological treatment, such as severe depression, suicide risk, OCD, psychosis/substance abuse issues, autism spectrum disorder
* Anxiety is largely related to bullying
* Extensive school absence of more than 50% in the last three months

Where it's running

  • Research centre for digital mental health services, Haukeland University Hospital
    Bergen, Vestland, Norway
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.