AnxietyNCT05758935
Feasibility and Pilot Study of a Rule-based Chatbot Application for Adolescents With Anxiety Symptoms
A study testing Rule-based chatbot intervention with therapist-guidance in people with Anxiety, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
The goal of this feasibility and pilot study is to investigate the feasibility and preliminary clinical effects of a new rule-based chatbot intervention for adolescents with anxiety symptoms. Read more about this study
- Who is it for?
- Ages 13 to 16 years
- Conditions the study is for
- Anxiety
- What is being tested?
- Rule-based chatbot intervention with therapist-guidance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteNorway
- Study dates
- 27 Apr 2023to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- reporting anxiety symptoms that hinders them in participating in daily activities
- spending time trying to avoid these anxiety symptoms
- aged 13 and up to 16 years
- can read Norwegian
Who cannot join
- clinical cut-off on OCD subscale on RCADS-47> 10,
- clinical cut-off on Depression subscale on RCADS-47 > 16,
- ongoing treatment
- extensive reading/writing difficulties
- extensive concentration problems
Trial locations and contacts
1 site in 1 country.
Norway1 site
Research centre for digital mental health services, Haukeland University Hospital
Bergen, Vestland, 5009
About this study
The goal of this feasibility and pilot study is to investigate the feasibility and preliminary clinical effects of a new rule-based chatbot intervention for adolescents with anxiety symptoms. The main questions are:
- Is the intervention feasible for adolescents who are experiencing anxiety symptoms?
- How do the adolescents experience the use of the intervention?
- Does the intervention lead to a reduction in anxiety symptoms?
- Does the intervention lead to a clinically significant reliable improvement at functional level?
Read the detailed description
Anxiety is one of the most common psychiatric disorders and the anxiety symptoms typically onsets in adolescence. The anxiety symptoms may be persistent into adulthood, leading to a poorer life quality and function impairments. The goal is to prevent the development of anxiety and comorbid disorders, as well as function impairment due to anxiety symptoms. This study wishes to investigate the feasibility and preliminary clinical effects of a digital intervention in an open pre-post and 3 months follow up study. The intervention consists of a rule-based click-chatbot, combined with therapist-guidance. This study will recruit N = 30 adolescents from Norway from age 13 up to 16 years old to investigate the feasibility and preliminary clinical effects of a rule-based click chatbot-intervention, and whether it causes a reduction in anxiety symptoms and increases of life functioning. If the intervention is feasible with promising results, the study will serve as a first step to a future randomized controlled trial.
- Conditions
- Anxiety
- Being tested
- Rule-based chatbot intervention with therapist-guidance
- Keywords
- Adolescents, Anxiety, Chatbot intervention, Technology-delivered intervention
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rule-based chatbot intervention with therapist-guidanceOther
The intervention is a mobile application designed as a rule-based chatbot. The chatbot will present psychoeducational text, videos and ask questions based on cognitive behavioral techniques. The adolescents will receive weekly therapist support within the mobile application, in addition to weekly contact by phone. The intervention has a duration of six weeks, with a total of six modules.
| Study group | Role | What they receive |
|---|---|---|
| Mobile application | Experimental | A six weeks, rule-based chatbot intervention Receives: Other: Rule-based chatbot intervention with therapist-guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revised Child Anxiety and Depression Scale -47 - Self-report
anxiety and depressive symptoms, higher score indicates worse outcomes
Measured: assessing change from screening, pre, immediately after the intervention, follow-up 1 month, and at follow-up 3 months
Revised Child Anxiety and Depression Scale - 25 - Self-report
short version of RCADS-47, measuring anxiety and depressive symptoms, with a higher score indicating worse symptoms
Measured: assessing change from week 2, and week 4
Revised Child Anxiety and Depression Scale -47 - Parent version
parent-reported anxiety and depressive symptoms, higher score indicates worse outcomes
Measured: assessing change from pre, immediately after the intervention, follow-up 1 month, and at follow-up 3 months
Revised Child Anxiety and Depression Scale - 25 - Parent version
parent-reported, short version of RCADS-47, measuring anxiety and depressive symptoms, with a higher score indicating worse symptoms
Measured: assessing change from week 2, and week 4
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 pre, immediately after the intervention, follow up 1 month, and at follow-up 3 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 the adolescents' functional level. The last component is used at follow up which also includes two additional follow-up questions
Measured: assessing change from pre, immediately after the intervention, follow up 1 month, and at follow-up 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start27 Apr 2023
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway
- Responsible party
- Sponsor
- Investigators
- Smiti Kahlon, PhD, Principal investigator, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05758935
- Sponsor's protocol ID
- 259293
- Status last verified
- Aug 2025
- First submitted
- 17 Jan 2023
- 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
- Feasibility and Pilot Study of a Rule-based Chatbot Application for Adolescents With Anxiety Symptoms
- ClinicalTrials.gov ID
- NCT05758935
- Acronym / sponsor ID
- 259293
- Conditions
- Anxiety
- Keywords
- Adolescents, Anxiety, Chatbot intervention, Technology-delivered intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- The Research Council of Norway
- Study start
- 27 Apr 2023 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 8 Mar 2023 (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 feasibility and pilot study is to investigate the feasibility and preliminary clinical effects of a new rule-based chatbot intervention for adolescents with anxiety symptoms. The main questions are:
- Is the intervention feasible for adolescents who are experiencing anxiety symptoms?
- How do the adolescents experience the use of the intervention?
- Does the intervention lead to a reduction in anxiety symptoms?
- Does the intervention lead to a clinically significant reliable improvement at functional level?
Detailed description
Anxiety is one of the most common psychiatric disorders and the anxiety symptoms typically onsets in adolescence. The anxiety symptoms may be persistent into adulthood, leading to a poorer life quality and function impairments. The goal is to prevent the development of anxiety and comorbid disorders, as well as function impairment due to anxiety symptoms. This study wishes to investigate the feasibility and preliminary clinical effects of a digital intervention in an open pre-post and 3 months follow up study. The intervention consists of a rule-based click-chatbot, combined with therapist-guidance. This study will recruit N = 30 adolescents from Norway from age 13 up to 16 years old to investigate the feasibility and preliminary clinical effects of a rule-based click chatbot-intervention, and whether it causes a reduction in anxiety symptoms and increases of life functioning. If the intervention is feasible with promising results, the study will serve as a first step to a future randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mobile application | Experimental | Other: Rule-based chatbot intervention with therapist-guidanceA six weeks, rule-based chatbot intervention |
Who may qualify
- Ages
- 13 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- reporting anxiety symptoms that hinders them in participating in daily activities
- spending time trying to avoid these anxiety symptoms
- aged 13 and up to 16 years
- can read Norwegian
Key exclusion criteria (5 listed)
- clinical cut-off on OCD subscale on RCADS-47> 10,
- clinical cut-off on Depression subscale on RCADS-47 > 16,
- ongoing treatment
- extensive reading/writing difficulties
- extensive concentration problems
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 |
|---|---|---|
| Rule-based chatbot intervention with therapist-guidanceThe intervention is a mobile application designed as a rule-based chatbot. The chatbot will present psychoeducational text, videos and ask questions based on cognitive behavioral techniques. The adolescents will receive weekly therapist support within the mobile application, in addition to weekly contact by phone. The intervention has a duration of six weeks, with a total of six modules. | Other | Mobile application |
Primary outcome
Revised Child Anxiety and Depression Scale -47 - Self-report
Time frame: assessing change from screening, pre, immediately after the intervention, follow-up 1 month, and at follow-up 3 months
anxiety and depressive symptoms, higher score indicates worse outcomes
Revised Child Anxiety and Depression Scale - 25 - Self-report
Time frame: assessing change from week 2, and week 4
short version of RCADS-47, measuring anxiety and depressive symptoms, with a higher score indicating worse symptoms
Revised Child Anxiety and Depression Scale -47 - Parent version
Time frame: assessing change from pre, immediately after the intervention, follow-up 1 month, and at follow-up 3 months
parent-reported anxiety and depressive symptoms, higher score indicates worse outcomes
Revised Child Anxiety and Depression Scale - 25 - Parent version
Time frame: assessing change from week 2, and week 4
parent-reported, short version of RCADS-47, measuring anxiety and depressive symptoms, with a higher score indicating worse symptoms
2 secondary outcomes
Strengths and Difficulties Questionnaire - Youth version
Time frame: assessing change from pre, immediately after the intervention, follow up 1 month, and at follow-up 3 months
Strengths and Difficulties Questionnaire - Parent version
Time frame: assessing change from pre, immediately after the intervention, follow up 1 month, and at follow-up 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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. This study is not recruiting at the moment.
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 Rule-based chatbot intervention with therapist-guidance in people with Anxiety, 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 4 inclusion and 5 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Revised Child Anxiety and Depression Scale -47 - Self-report (time frame: assessing change from screening, pre, immediately after the intervention, follow-up 1 month, and at follow-up 3 months). The study lists 4 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.