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?

Study Overview

• Status: Recruiting
• Conditions: Anxiety
• Intervention / Treatment: Other: Rule-based chatbot intervention with therapist-guidance

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tine Nordgreen, PhD; Phone Number: +4790094913; Email: tine.nordgreen@helse-bergen.no
• Study Contact Backup: Name: Smiti Kahlon, PhD; Phone Number: +4798866640; Email: smiti.kahlon@helse-bergen.no

Study Locations

• Norway
  • Vestland
    • Bergen, Vestland, Norway, 5009
      • Recruiting
      • Research centre for digital mental health services, Haukeland University Hospital
      • Contact: Tine Nordgreen, PhD; Email: tine.nordgreen@helse-bergen.no
      • Contact: Smiti Kahlon, PhD; Phone Number: 004798866640; Email: smiti.kahlon@helse-bergen.no
      • Principal Investigator: Smiti Kahlon, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Mobile application; A six weeks, rule-based chatbot intervention

Other: Rule-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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motivation Questionnaire	assessments of their motivation to participate in the intervention, developed specifically for this study	week 2
Evaluation Questionnaire	evaluation assessments of the intervention, developed specifically for this study.	immediately after the intervention
Demographics	gender, age	pre-intervention

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Collaborators: The Research Council of Norway
• Investigators: Principal Investigator: Smiti Kahlon, PhD, Haukeland University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2023
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: January 17, 2023
• First Submitted That Met QC Criteria: February 24, 2023
• First Posted (Actual): March 8, 2023

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Adolescents; Anxiety; Chatbot intervention; Technology-delivered intervention
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 259293

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: starting six months after publication
• IPD Sharing Access Criteria: IPD will be made available from PI on reasonable request and according to relevant Norwegian laws and regulations
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No