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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05758935
Enrollment
25
Registered
2023-03-08
Start date
2023-04-27
Completion date
2024-11-30
Last updated
2025-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety

Keywords

Adolescents, Anxiety, Chatbot intervention, Technology-delivered intervention

Brief 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. 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.

Interventions

OTHERRule-based chatbot intervention with therapist-guidance

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.

Sponsors

The Research Council of Norway
CollaboratorOTHER
Haukeland University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
13 Years to 16 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Revised Child Anxiety and Depression Scale - 25 - Self-reportassessing change from week 2, and week 4short version of RCADS-47, measuring anxiety and depressive symptoms, with a higher score indicating worse symptoms
Revised Child Anxiety and Depression Scale -47 - Self-reportassessing change from screening, pre, immediately after the intervention, follow-up 1 month, and at follow-up 3 monthsanxiety and depressive symptoms, higher score indicates worse outcomes
Revised Child Anxiety and Depression Scale -47 - Parent versionassessing change from pre, immediately after the intervention, follow-up 1 month, and at follow-up 3 monthsparent-reported anxiety and depressive symptoms, higher score indicates worse outcomes
Revised Child Anxiety and Depression Scale - 25 - Parent versionassessing change from week 2, and week 4parent-reported, short version of RCADS-47, measuring anxiety and depressive symptoms, with a higher score indicating worse symptoms

Secondary

MeasureTime frameDescription
Strengths and Difficulties Questionnaire - Parent versionassessing change from pre, immediately after the intervention, follow up 1 month, and at follow-up 3 monthsThe 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
Strengths and Difficulties Questionnaire - Youth versionassessing change from pre, immediately after the intervention, follow up 1 month, and at follow-up 3 monthsThe 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

Other

MeasureTime frameDescription
Motivation Questionnaireweek 2assessments of their motivation to participate in the intervention, developed specifically for this study
Demographicspre-interventiongender, age
Evaluation Questionnaireimmediately after the interventionevaluation assessments of the intervention, developed specifically for this study.

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026