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

NCT05758935 | Completed

• 1 other identifier: 259293
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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?

Conditions

Anxiety

Keywords

Adolescents; Anxiety; Chatbot intervention; Technology-delivered intervention

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Strengths and Difficulties Questionnaire - Youth version

  assessing change from pre, immediately after the intervention, follow up 1 month, and at follow-up 3 months

• Strengths and Difficulties Questionnaire - Parent version

  assessing change from pre, immediately after the intervention, follow up 1 month, and at follow-up 3 months

Other Outcomes (3)

• Motivation Questionnaire

  week 2

• Evaluation Questionnaire

  immediately after the intervention

• Demographics

  pre-intervention

Study Arms (1)

Mobile application

EXPERIMENTAL

A six weeks, rule-based chatbot intervention

Other: Rule-based chatbot intervention with therapist-guidance

Interventions

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.

Mobile application

Eligibility Criteria

• Age: 13 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Haukeland University Hospital: lead
• The Research Council of Norway: collaborator

Study Sites (1)

Research centre for digital mental health services, Haukeland University Hospital

Bergen, Vestland, 5009, Norway

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Smiti Kahlon, PhD

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: March 8, 2023
• Study Start: April 27, 2023
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: starting six months after publication
• Access Criteria: IPD will be made available from PI on reasonable request and according to relevant Norwegian laws and regulations

Locations

NO (1)