Actively Recruiting

Phase Not Applicable
Age: 13Years - 16Years
All Genders
ID06531980

Effectiveness of a Digital Therapist-Guided Application for Adolescents With Mild to Moderate Anxiety Compared to Treatment as Usual

Led by Haukeland University Hospital · Updated on 2025-08-28

128

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

Sponsors

H

Haukeland University Hospital

Lead Sponsor

B

Bergen kommune

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of a new therapist-guided, rule-based digital intervention called Modi for adolescents aged 13 to 16 with mild to moderate anxiety. This randomized controlled trial compares the Modi mobile app, which is based on cognitive behavioral therapy (CBT), to treatment as usual at the Child and Family Help Center in Bergen Municipality. The goal is to see if the intervention reduces anxiety symptoms and improves functional levels in young people. The Modi intervention lasts for 8 weeks and is delivered through a mobile app featuring a rule-based chatbot named "Anna" that guides users through educational content and exercises. The program includes six chapters with psychoeducation, cognitive therapy concepts, and exposure exercises, supported by animated videos, illustrations, and audio. Participants receive weekly personalized support from Modi therapists via messages and phone calls. The comparison group receives regular treatment from local Child and Family Services, which may include individual therapy, parental counseling, and assessments following national clinical guidelines. During the study, participants complete self- and parent-reported anxiety and depression scales (RCADS-25) at screening, before starting, during weeks 2, 4, 6, immediately after the intervention, and at 1- and 6-month follow-ups. Secondary measures include youth and parent versions of the Strengths and Difficulties Questionnaire at similar time points. Researchers will monitor changes in anxiety symptoms and functioning throughout the study, which runs until December 2026.

CONDITIONS

Brief Title

Effectiveness of a Digital Application for Adolescents With Mild to Moderate Anxiety

Who Can Participate

Age: 13Years - 16Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ages 13 to 16 years
  • Resides in Bergen
  • Completed the Revised Child Anxiety and Depression Scale (RCADS-25)
  • Reports experiencing anxiety symptoms such as stress, fear, worry, or physical symptoms like stomach pain or heart palpitations
  • Reports that anxiety symptoms interfere with daily activities or cause excessive worry
  • Can read Norwegian
Not Eligible

You will not qualify if you...

  • Currently receiving other psychological treatment
  • Immediate need for other psychological treatment due to severe depression, suicide risk, OCD, psychosis, substance abuse, or autism spectrum disorder
  • Anxiety mainly caused by bullying
  • Absence from school greater than 50% in the past three months

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 8 weeks

Participants receive either the eight-week therapist-guided Modi mobile application intervention or treatment as usual at their local Child and Family Services.

Weekly visits for up to 8 weeks

Follow-up

Duration - 6 months

Participants are monitored for changes in anxiety and depression symptoms after the intervention.

Visits at 1 month and 6 months after treatment completion

Trial Site Locations

Total: 1 location

1

Research centre for digital mental health services, Haukeland University Hospital

Bergen, Vestland, Norway, 5009

Actively Recruiting

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Research Team

S

Smiti Kahlon, PhD

T

Tine Nordgreen, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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