Clinical trial NCT05758935: Feasibility and Pilot Study of a Rule-based Chatbot Application for Adolescents With Anxiety Symptoms
Official title: Feasibility and Pilot Study of a Rule-based Chatbot Application for Adolescents With Anxiety Symptoms
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anxiety
Keywords: Adolescents
Anxiety
Chatbot intervention
Technology-delivered intervention
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
First posted: 2023-03-08
Enrollment: 30
Sex: ALL
Minimum age (years): 13
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Revised Child Anxiety and Depression Scale -47 - Self-report
timeFrame: assessing change from screening, pre, immediately after the intervention, follow-up 1 month, and at follow-up 3 months
measure: Revised Child Anxiety and Depression Scale - 25 - Self-report
timeFrame: assessing change from week 2, and week 4
measure: Revised Child Anxiety and Depression Scale -47 - Parent version
timeFrame: assessing change from pre, immediately after the intervention, follow-up 1 month, and at follow-up 3 months
measure: Revised Child Anxiety and Depression Scale - 25 - Parent version
timeFrame: assessing change from week 2, and week 4
Secondary outcomes:
measure: Strengths and Difficulties Questionnaire - Youth version
timeFrame: assessing change from pre, immediately after the intervention, follow up 1 month, and at follow-up 3 months
measure: Strengths and Difficulties Questionnaire - Parent version
timeFrame: assessing change from pre, immediately after the intervention, follow up 1 month, and at follow-up 3 months
Other outcomes:
measure: Motivation Questionnaire
timeFrame: week 2
measure: Evaluation Questionnaire
timeFrame: immediately after the intervention
measure: Demographics
timeFrame: pre-intervention
Locations:
city: Bergen
country: Norway
facility: Research centre for digital mental health services, Haukeland University Hospital
state: Vestland
Study officials:
affiliation: Haukeland University Hospital
name: Smiti Kahlon, PhD
role: PRINCIPAL_INVESTIGATOR
References: