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

ConditionsAnxiety Anxiety and Fear Adolescent - Emotional Problem

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age13-16

SponsorHaukeland University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Ages 13-16

Resides in Bergen

Completed RCADS-25

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)?

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

Modi
Other intervention
The Modi course, an eight-week mobile application intervention for adolescents with anxiety symptoms, is based on cognitive therapy. Guided by a rule-based chatbot named "Anna," users navigate through predefined options and responses, learning about anxiety and recording their challenges. The app includes animated videos, illustrations, and audio files to enhance engagement. Modi consists of six chapters, with a focus on psychoeducation, the cognitive triangle, and exposure exercises. Participants receive guidance from two Modi therapists who provide weekly support via messages and scheduled phone calls, ensuring personalized assistance and addressing any issues throughout the course.
Treatment as usual
Other intervention
Participants receive usual treatment at their local Child and Family Services. This treatment, known as Treatment as Usual (TAU), is not standardized but reflects the care they would receive in regular practice. It aligns with national clinical guidelines and includes individual therapy, parental counseling, and assessments. Typically, the treatment is provided by a therapist trained in cognitive behavioral therapy (CBT) or a psychologist

Treatment groups

128 Participants

are divided into 2 treatment groups

Group A: Modi-applicationExperimental treatment 1 intervention

Group B: Treatment as usualActive comparator 1 intervention

Trial outcomes

Primary outcomes

Revised Child Anxiety and Depression Scale - 25 - Self-report

anxiety and depressive symptoms, higher score indicates worse outcomes

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]

Revised Child Anxiety and Depression Scale - 25 - Parent-report

anxiety and depressive symptoms, higher score indicates worse outcomes

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]

Secondary outcomes

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

Time frame

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

Time frame

assessing change from screening, pre, week 4, immediately after the intervention, follow-up 1 month, and at follow-up 6 months]

Other outcomes

Motivation Questionnaire

assessments of their motivation to participate in the study and interventions, developed specifically for this study

Time frame

week 2

Evaluation Questionnaire

evaluation assessments of the Modi intervention, developed specifically for this study.

Time frame

immediately after the intervention

Qualitative interviews

Interviews with 15 adolescents from the Modi-group about their experience using the intervention

Time frame

immediately after the intervention

demographics

gender, age

Time frame

pre-intervention

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Haukeland University Hospital

Lead sponsor

Bergen kommune

Collaborator

Source ClinicalTrials.gov

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