Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2025-12-24 @ 10:29 PM
Study NCT ID:
NCT05758935
Status:
COMPLETED
Last Update Posted:
2025-08-28
First Post:
2023-01-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility and Pilot Study of a Rule-based Chatbot Application for Adolescents With Anxiety Symptoms
Sponsor:
Haukeland University Hospital
Organization:
Study Overview
Official Title:
Feasibility and Pilot Study of a Rule-based Chatbot Application for Adolescents With Anxiety Symptoms
Status:
COMPLETED
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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?
* 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: