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NCT Number: NCT06531980

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

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.

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Key information

Conditions

Anxiety Adolescent - Emotional Problem Anxiety Disorders Anxiety and Fear Mental Disorders

Age range

13 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research centre for digital mental health services, Haukeland University Hospital

Bergen, Vestland, 5009, Norway

Location status: Recruiting

Location contact

Smiti Kahlon, PhD

CONTACT

[email protected]

004798866640

Smiti Kahlon, PhD

PRINCIPAL_INVESTIGATOR

Tine Nordgreen, PhD

CONTACT

[email protected]

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Modi

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

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

Primary outcomes

  1. Revised Child Anxiety and Depression Scale - 25 - Self-report

    Time frame: 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]

    anxiety and depressive symptoms, higher score indicates worse outcomes

  2. Revised Child Anxiety and Depression Scale - 25 - Parent-report

    Time frame: 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]

    anxiety and depressive symptoms, higher score indicates worse outcomes

Secondary outcomes

  1. Strengths and Difficulties Questionnaire - Youth version

    Time frame: assessing change from screening, pre, week 4, immediately after the intervention, follow-up 1 month, and at follow-up 6 months]

    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

  2. Strengths and Difficulties Questionnaire - Parent version

    Time frame: assessing change from screening, pre, week 4, immediately after the intervention, follow-up 1 month, and at follow-up 6 months]

    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

Other outcomes

  1. Motivation Questionnaire

    Time frame: week 2

    assessments of their motivation to participate in the study and interventions, developed specifically for this study

  2. Evaluation Questionnaire

    Time frame: immediately after the intervention

    evaluation assessments of the Modi intervention, developed specifically for this study.

  3. Qualitative interviews

    Time frame: immediately after the intervention

    Interviews with 15 adolescents from the Modi-group about their experience using the intervention

  4. demographics

    Time frame: pre-intervention

    gender, age

Study contacts

Contact information is provided by the study sponsor or research team.

Smiti Kahlon, PhD

CONTACT

[email protected]

+4798866640

Tine Nordgreen, PhD

CONTACT

[email protected]

+4790094913

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Collaborators

  • Bergen kommune

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 1, 2024
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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