Feasibility and Pilot Study of a Rule-based Chatbot Application for Adolescents With Anxiety Symptoms

Study Overview
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Brief Summary
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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
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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.

Official Title
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Feasibility and Pilot Study of a Rule-based Chatbot Application for Adolescents With Anxiety Symptoms

Conditions
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Anxiety

Intervention / Treatment
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* Other: Rule-based chatbot intervention with therapist-guidance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobile application<br>A six weeks, rule-based chatbot intervention | Other: Rule-based chatbot intervention with therapist-guidance<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Revised Child Anxiety and Depression Scale -47 - Self-report | anxiety and depressive symptoms, higher score indicates worse outcomes | 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 | 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 | 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 | assessing change from week 2, and week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 | assessing change from pre, immediately after the intervention, follow up 1 month, and at follow-up 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescents, Anxiety, Chatbot intervention, Technology-delivered intervention