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

NCT ID: NCT05758935

Last Updated: 2025-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-27
• Study Completion Date: 2024-11-30

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.

Conditions

Anxiety

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mobile application

A six weeks, rule-based chatbot intervention

Group Type: EXPERIMENTAL

Rule-based chatbot intervention with therapist-guidance

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Research Council of Norway

OTHER

Sponsor Role: collaborator

Haukeland University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Smiti Kahlon, PhD

Role: PRINCIPAL_INVESTIGATOR

Haukeland University Hospital

Locations

Research centre for digital mental health services, Haukeland University Hospital

Bergen, Vestland, Norway

Countries

Norway

Other Identifiers

259293

Identifier Type: -

Identifier Source: org_study_id