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

N/ARecruitingNCT06531980

Haukeland University Hospital128 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

128

Conditions

Anxiety

Interventions

ModiOTHER

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 usualOTHER

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

Eligibility

Sex: ALLMin age: 13 YearsMax age: 16 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

anxiety and depressive symptoms, higher score indicates worse outcomes

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]

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

anxiety and depressive symptoms, higher score indicates worse outcomes

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]

Secondary Outcomes

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

Time frame: 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