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

NCT06531980 | Recruiting

• 1 other identifier: 714490
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Anxiety and Fear; Adolescent - Emotional Problem

Keywords

Digital Health; Digital interventions; Cognitive behavior therapy; adolescent; anxiety

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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]

• 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]

Other Outcomes (4)

• Motivation Questionnaire

  week 2

• Evaluation Questionnaire

  immediately after the intervention

• Qualitative interviews

  immediately after the intervention

Study Arms (2)

Modi-application

EXPERIMENTAL

8-weeks interventions provided by the mobile application Modi. Therapist-guided intervention

Other: Modi

Treatment as usual

ACTIVE COMPARATOR

The group will receive treatment as usual.

Other: Treatment as usual

Interventions

Modi OTHER

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.

Modi-application

Treatment as usual OTHER

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 as usual

Eligibility Criteria

• Age: 13 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Haukeland University Hospital: lead
• Bergen kommune: collaborator

Study Sites (1)

Research centre for digital mental health services, Haukeland University Hospital

Bergen, Vestland, 5009, Norway

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Smiti Kahlon, PhD

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Smiti Kahlon, PhD

CONTACT

+4798866640; smiti.kahlon@helse-bergen.no

Tine Nordgreen, PhD

CONTACT

+4790094913; tine.nordgreen@helse-bergen.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: A member of the research group will conduct the randomization
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One group receives the digittal health intervention and one group receives treatment as usual

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: August 1, 2024
• Study Start: January 16, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: starting after publication
• Access Criteria: PD will be made available from PI on reasonable request and according to relevant Norwegian laws and regulations

Locations

NO (1)