Clinical trial NCT06531980: Effectiveness of a Digital Application for Adolescents With Mild to Moderate Anxiety
Official title: Effektiviteten av en Digital Mestringsapp for Ungdommer Med Mild Til Moderat Angst
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anxiety
Anxiety and Fear
Adolescent - Emotional Problem
Keywords: Digital Health
Digital interventions
Cognitive behavior therapy
adolescent
anxiety
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: Bergen kommune
First posted: 2024-08-01
Enrollment: 128
Sex: ALL
Minimum age (years): 13
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group receives the digittal health intervention and one group receives treatment as usual
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Revised Child Anxiety and Depression Scale - 25 - Self-report
timeFrame: 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]
measure: Revised Child Anxiety and Depression Scale - 25 - Parent-report
timeFrame: 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:
measure: Strengths and Difficulties Questionnaire - Youth version
timeFrame: assessing change from screening, pre, week 4, immediately after the intervention, follow-up 1 month, and at follow-up 6 months]
measure: Strengths and Difficulties Questionnaire - Parent version
timeFrame: assessing change from screening, pre, week 4, immediately after the intervention, follow-up 1 month, and at follow-up 6 months]
Other outcomes:
measure: Motivation Questionnaire
timeFrame: week 2
measure: Evaluation Questionnaire
timeFrame: immediately after the intervention
measure: Qualitative interviews
timeFrame: immediately after the intervention
measure: demographics
timeFrame: pre-intervention
Locations:
city: Bergen
country: Norway
facility: Research centre for digital mental health services, Haukeland University Hospital
state: Vestland
Study officials:
affiliation: Haukeland University Hospital
name: Smiti Kahlon, PhD
role: PRINCIPAL_INVESTIGATOR
References: