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

Haukeland University Hospital

Status: Enrolling

Conditions: Anxiety and Fear; Adolescent - Emotional Problem; Anxiety

Treatments: Other: Modi; Other: Treatment as usual

Study type: Interventional

Funder types: Other

Identifiers

NCT06531980

714490

Details and patient eligibility

About

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.

Full 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

Enrollment: 128 estimated patients

Sex: All

Ages: 13 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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128 participants in 2 patient groups

Modi-application

Experimental group

Description:

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

Treatment:

Other: Modi

Treatment as usual

Active Comparator group

Description:

The group will receive treatment as usual.

Treatment:

Other: Treatment as usual