Effectiveness of a Digital Application for Adolescents With Mild to Moderate Anxiety
NCT Number: NCT06531980
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Anxiety|Anxiety and Fear|Adolescent - Emotional Problem
Interventions: OTHER: Modi|OTHER: Treatment as usual
Sponsor: Haukeland University Hospital
Collaborators: Bergen kommune
Sex: ALL
Age: CHILD
Enrollment: 128
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2026-09-30
Locations: Research centre for digital mental health services, Haukeland University Hospital, Bergen, Vestland, 5009, Norway

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.

Primary Outcome Measures: Revised Child Anxiety and Depression Scale - 25 - Self-report, anxiety and depressive symptoms, higher score indicates worse outcomes, 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, 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 Outcome Measures: 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, 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, assessing change from screening, pre, week 4, immediately after the intervention, follow-up 1 month, and at follow-up 6 months]
Other Outcome Measures: Motivation Questionnaire, assessments of their motivation to participate in the study and interventions, developed specifically for this study, week 2|Evaluation Questionnaire, evaluation assessments of the Modi intervention, developed specifically for this study., immediately after the intervention|Qualitative interviews, Interviews with 15 adolescents from the Modi-group about their experience using the intervention, immediately after the intervention|demographics, gender, age, pre-intervention