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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05758935
• Other study ID #: 259293
• Status: Recruiting
• Phase: N/A
• Start date: April 27, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: February 2023
• Source: Haukeland University Hospital
• Contact: Smiti Kahlon, PhD
• Phone: +4798866640
• Email: smiti.kahlon[@]helse-bergen.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

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.

Locations

Country	Name	City	State
Norway	Research centre for digital mental health services, Haukeland University Hospital	Bergen	Vestland

Sponsors (2)

Lead Sponsor	Collaborator
Haukeland University Hospital	The Research Council of Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Motivation Questionnaire	assessments of their motivation to participate in the intervention, developed specifically for this study	week 2
Other	Evaluation Questionnaire	evaluation assessments of the intervention, developed specifically for this study.	immediately after the intervention
Other	Demographics	gender, age	pre-intervention
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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