AnxietyNCT06531980
Effectiveness of a Digital Application for Adolescents With Mild to Moderate Anxiety
A study testing Modi and Treatment as usual in people with Anxiety and Anxiety and Fear, run by Haukeland University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 16 years
- Conditions the study is for
- Anxiety, Anxiety and Fear, Adolescent - Emotional Problem
- What is being tested?
- Modi and Treatment as usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteNorway
- Study dates
- 16 Jan 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Research centre for digital mental health services, Haukeland University Hospital
Bergen, Vestland, 5009
Smiti Kahlon, PhD, 004798866640, smiti.kahlon@helse-bergen.no
Tine Nordgreen, PhD, tine.nordgreen@helse-bergen.no
About this study
Official title: Effektiviteten av en Digital Mestringsapp for Ungdommer Med Mild Til Moderat Angst
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.
Read the 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
- Conditions
- Anxiety, Anxiety and Fear, Adolescent - Emotional Problem
- Being tested
- Modi, Treatment as usual
- Keywords
- Digital Health, Digital interventions, Cognitive behavior therapy, adolescent, anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ModiOther
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 usualOther
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
| Study group | Role | What they receive |
|---|---|---|
| Modi-application | Experimental | 8-weeks interventions provided by the mobile application Modi. Therapist-guided intervention Receives: Other: Modi |
| Treatment as usual | Active comparator | The group will receive treatment as usual. Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revised Child Anxiety and Depression Scale - 25 - Self-report
anxiety and depressive symptoms, higher score indicates worse outcomes
Measured: 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
Measured: 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
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
Measured: 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
Measured: assessing change from screening, pre, week 4, immediately after the intervention, follow-up 1 month, and at follow-up 6 months]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start16 Jan 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One group receives the digittal health intervention and one group receives treatment as usual
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bergen kommune
- Responsible party
- Sponsor
- Investigators
- Smiti Kahlon, PhD, Principal investigator, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06531980
- Sponsor's protocol ID
- 714490
- Status last verified
- Aug 2025
- First submitted
- 28 Jun 2024
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The full protocol and informed consent forms are available upon request. The datasets and the statistical code will not be publicly available, but may be available upon reasonable request through correspondence with principal investigator and according to the Norwegian law and regulations.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effektiviteten av en Digital Mestringsapp for Ungdommer Med Mild Til Moderat Angst
- ClinicalTrials.gov ID
- NCT06531980
- Acronym / sponsor ID
- 714490
- Conditions
- Anxiety, Anxiety and Fear, Adolescent - Emotional Problem
- Keywords
- Digital Health, Digital interventions, Cognitive behavior therapy, adolescent, anxiety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- Bergen kommune
- Study start
- 16 Jan 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 1 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- One group receives the digittal health intervention and one group receives treatment as usual
| Arm | Type | Receives |
|---|---|---|
| Modi-application | Experimental | Other: Modi8-weeks interventions provided by the mobile application Modi. Therapist-guided intervention |
| Treatment as usual | Active comparator | Other: Treatment as usualThe group will receive treatment as usual. |
Who may qualify
- Ages
- 13 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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)?
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ModiThe 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. | Other | Modi-application |
| Treatment as usualParticipants 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 | Other | Treatment as usual |
Primary outcome
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
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
2 secondary outcomes
Strengths and Difficulties Questionnaire - Youth version
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
Time frame: assessing change from screening, pre, week 4, immediately after the intervention, follow-up 1 month, and at follow-up 6 months]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Individual participant dataSharing planned: Yes. The full protocol and informed consent forms are available upon request. The datasets and the statistical code will not be publicly available, but may be available upon reasonable request through correspondence with principal investigator and according to the Norwegian law and regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Smiti Kahlon, PhD principal investigator
Haukeland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modi and Treatment as usual in people with Anxiety and Anxiety and Fear, run by Haukeland University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Smiti Kahlon, PhD (+4798866640, smiti.kahlon@helse-bergen.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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]). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.