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

NCT ID: NCT06531980

Last Updated: 2025-08-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-16
• Study Completion Date: 2026-12-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Modi-application

8-weeks interventions provided by the mobile application Modi. Therapist-guided intervention

Group Type: EXPERIMENTAL

Modi

Intervention Type: OTHER

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.

Treatment as usual

The group will receive treatment as usual.

Group Type: ACTIVE_COMPARATOR

Treatment as usual

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bergen kommune

UNKNOWN

Sponsor Role: collaborator

Haukeland University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Smiti Kahlon, PhD

Role: PRINCIPAL_INVESTIGATOR

Haukeland University Hospital

Locations

Research centre for digital mental health services, Haukeland University Hospital

Bergen, Vestland, Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Smiti Kahlon, PhD

Role: CONTACT

smiti.kahlon@helse-bergen.no

+4798866640

Tine Nordgreen, PhD

Role: CONTACT

tine.nordgreen@helse-bergen.no

+4790094913

Facility Contacts

Smiti Kahlon, PhD

Role: primary

smiti.kahlon@helse-bergen.no

004798866640

Tine Nordgreen, PhD

Role: backup

tine.nordgreen@helse-bergen.no

Other Identifiers

714490

Identifier Type: -

Identifier Source: org_study_id