Modi: a therapist-guided digital CBT app for teens with mild to moderate anxiety
Effektiviteten av en Digital Mestringsapp for Ungdommer Med Mild Til Moderat Angst
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.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 13 Years to 16 Years |
| Sex | All |
| Sponsor | Haukeland University Hospital Academic / other |
| Locations | 1 site (Bergen, Vestland) |
| Trial ID | NCT06531980 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Previous digital CBT programs for adolescent anxiety have shown moderate benefit, but therapist-guided rule-based chatbot interventions remain relatively novel with limited evidence.
Eligibility criteria
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 this trial is running
Bergen, Vestland
- Research centre for digital mental health services, Haukeland University Hospital — Bergen, Vestland, Norway (Recruiting)
Study contacts
- Principal investigator: Smiti Kahlon, PhD — Haukeland University Hospital
- Study coordinator: Smiti Kahlon, PhD
- Email: smiti.kahlon@helse-bergen.no
- Phone: +4798866640
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.