Effectiveness of a Digital Application for Adolescents With Mild to Moderate Anxiety
- Conditions
- Adolescent - Emotional ProblemAnxietyAnxiety and Fear
- Interventions
- Other: ModiOther: Treatment as usual
- Registration Number
- NCT06531980
- Lead Sponsor
- Haukeland University Hospital
- 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
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 128
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Modi-application Modi 8-weeks interventions provided by the mobile application Modi. Therapist-guided intervention Treatment as usual Treatment as usual The group will receive treatment as usual.
- Primary Outcome Measures
Name Time Method Revised Child Anxiety and Depression Scale - 25 - Parent-report 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 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 Outcome Measures
Name Time Method 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] 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
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] 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
Trial Locations
- Locations (1)
Research centre for digital mental health services, Haukeland University Hospital
🇳🇴Bergen, Vestland, Norway