NCT06531980

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: Haukeland University Hospital · Academic / Other
• Sex: All
• Age: 13 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

The goal of this randomized controlled trial is to investigate the effectiveness of a new therapist-guided rule based intervention in Bergen Municipality, Child and Family help center. Do they have a decrease in anxiety symptoms following the intervention? Do they have an increase in functional level following the intervention? Researchers will compare the therapist-guided rule based intervention with treatment as usual for adolescents with mild to moderate anxiety. Participants will use the intervention, which is based on CBT, for 8 weeks.

Detailed description

Modi is a mobile application and consists of a training program for adolescents with anxiety problems. Anxiety is one of the most common mental disorders. The anxiety symptoms usually have an age of onset in adolescence. For many, these anxiety symptoms persist into adulthood, and lead to reduced quality of life and functional impairment. The goal is to prevent anxiety disorders, comorbid disorders and loss of function as a result of the anxiety symptoms. This study wants to investigate the effectiveness of a digital intervention in a randomized controlled trial. The study will recruit N = 128 young people aged 13-16 who will be randomized to either a therapist-guided, rule-based chatbot intervention or treatment as usual in the Child and Family Help Center in Bergen Municipality. The study will examine the clinical effects of the new intervention compared to treatment as usual

Conditions

• Anxiety
• Anxiety and Fear
• Adolescent - Emotional Problem

Interventions

Type	Name	Description
OTHER	Modi	The Modi course, an eight-week mobile application intervention for adolescents with anxiety symptoms, is based on cognitive therapy. Guided by a rule-based chatbot named "Anna," users navigate through predefined options and responses, learning about anxiety and recording their challenges. The app includes animated videos, illustrations, and audio files to enhance engagement. Modi consists of six chapters, with a focus on psychoeducation, the cognitive triangle, and exposure exercises. Participants receive guidance from two Modi therapists who provide weekly support via messages and scheduled phone calls, ensuring personalized assistance and addressing any issues throughout the course.
OTHER	Treatment as usual	Participants receive usual treatment at their local Child and Family Services. This treatment, known as Treatment as Usual (TAU), is not standardized but reflects the care they would receive in regular practice. It aligns with national clinical guidelines and includes individual therapy, parental counseling, and assessments. Typically, the treatment is provided by a therapist trained in cognitive behavioral therapy (CBT) or a psychologist

Timeline

• Start date: 2025-01-16
• Primary completion: 2026-08-31
• Completion: 2026-12-30
• First posted: 2024-08-01
• Last updated: 2025-08-28

Locations

1 site across 1 country: Norway