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Clinical Trials/NCT06531980
NCT06531980
Recruiting
Not Applicable

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

Haukeland University Hospital1 site in 1 country128 target enrollmentJanuary 16, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anxiety
Sponsor
Haukeland University Hospital
Enrollment
128
Locations
1
Primary Endpoint
Revised Child Anxiety and Depression Scale - 25 - Parent-report
Status
Recruiting
Last Updated
8 months ago

Overview

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

Registry
clinicaltrials.gov
Start Date
January 16, 2025
End Date
December 30, 2026
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Haukeland University Hospital
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

  • Strengths and Difficulties Questionnaire - Parent version(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 - Youth version(assessing change from screening, pre, week 4, immediately after the intervention, follow-up 1 month, and at follow-up 6 months])

Study Sites (1)

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