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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Anxiety; Anxiety and Fear; Adolescent - Emotional Problem
• Intervention / Treatment: Other: Modi; Other: Treatment as usual

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

• Study Type: Interventional
• Enrollment (Estimated): 128
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tine Nordgreen, PhD; Phone Number: +4790094913; Email: tine.nordgreen@helse-bergen.no
• Study Contact Backup: Name: Smiti Kahlon, PhD; Phone Number: +4798866640; Email: smiti.kahlon@helse-bergen.no

Study Locations

• Norway
  • Vestland
    • Bergen, Vestland, Norway, 5009
      • Recruiting
      • Research centre for digital mental health services, Haukeland University Hospital
      • Contact: Tine Nordgreen, PhD; Email: tine.nordgreen@helse-bergen.no
      • Contact: Smiti Kahlon, PhD; Phone Number: 004798866640; Email: smiti.kahlon@helse-bergen.no
      • Principal Investigator: Smiti Kahlon, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Modi-application; 8-weeks interventions provided by the mobile application Modi. Therapist-guided intervention	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.
Active Comparator: Treatment as usual; The group will receive treatment as usual.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Revised Child Anxiety and Depression Scale - 25 - Self-report	anxiety and depressive symptoms, higher score indicates worse outcomes	assessing change from screening, pre, week 2, week 4, week 6, and immediately after the intervention, follow-up 1 month, and at follow-up 6 months]
Revised Child Anxiety and Depression Scale - 25 - Parent-report	anxiety and depressive symptoms, higher score indicates worse outcomes	assessing change from screening, pre, week 2, week 4, week 6, and immediately after the intervention, follow-up 1 month, and at follow-up 6 months]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Strengths and Difficulties Questionnaire - Youth version	The scale measure adolescent's general mental health, with a higher score indicating worse symptoms. The study intends to use all three components of the measurement, including 1) the basis of SDQ, which includes 25 items on psychological attributes, 2) impact supplement, measuring functional level. The follow-up version also includes two additional follow-up questions	assessing change from screening, pre, week 4, immediately after the intervention, follow-up 1 month, and at follow-up 6 months]
Strengths and Difficulties Questionnaire - Parent version	The scale measure parent-reported adolescent's general mental health, with a higher score indicating worse symptoms. The study intends to use all three components of the measurement, including 1) the basis of SDQ, which includes 25 items on psychological attributes, 2) impact supplement, measuring functional level. The follow-up version also includes two additional follow-up questions	assessing change from screening, pre, week 4, immediately after the intervention, follow-up 1 month, and at follow-up 6 months]

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motivation Questionnaire	assessments of their motivation to participate in the study and interventions, developed specifically for this study	week 2
Evaluation Questionnaire	evaluation assessments of the Modi intervention, developed specifically for this study.	immediately after the intervention
Qualitative interviews	Interviews with 15 adolescents from the Modi-group about their experience using the intervention	immediately after the intervention
demographics	gender, age	pre-intervention

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Collaborators: Bergen kommune
• Investigators: Principal Investigator: Smiti Kahlon, PhD, Haukeland University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: June 28, 2024
• First Submitted That Met QC Criteria: July 31, 2024
• First Posted (Actual): August 1, 2024

Study Record Updates

• Last Update Posted (Estimated): August 28, 2025
• Last Update Submitted That Met QC Criteria: August 22, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: adolescent; anxiety; Cognitive behavior therapy; Digital Health; Digital interventions
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Therapeutics
• Other Study ID Numbers: 714490

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The full protocol and informed consent forms are available upon request. The datasets and the statistical code will not be publicly available, but may be available upon reasonable request through correspondence with principal investigator and according to the Norwegian law and regulations.
• IPD Sharing Time Frame: starting after publication
• IPD Sharing Access Criteria: PD will be made available from PI on reasonable request and according to relevant Norwegian laws and regulations
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No