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Completed

NCT Number: NCT05758935

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

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?

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

13 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research centre for digital mental health services, Haukeland University Hospital

Bergen, Vestland, 5009, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rule-based chatbot intervention with therapist-guidance

Other

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. 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

    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

  2. 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

    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

Other outcomes

  1. Motivation Questionnaire

    Time frame: week 2

    assessments of their motivation to participate in the intervention, developed specifically for this study

  2. Evaluation Questionnaire

    Time frame: immediately after the intervention

    evaluation assessments of the intervention, developed specifically for this study.

  3. Demographics

    Time frame: pre-intervention

    gender, age

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Collaborators

  • The Research Council of Norway

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 8, 2023
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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