Feasibility and Pilot Study of a Rule-based Chatbot Application for Adolescents With Anxiety Symptoms
Primary Purpose
Anxiety
Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Rule-based chatbot intervention with therapist-guidance
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety focused on measuring Adolescents, Anxiety, Chatbot intervention, Technology-delivered intervention
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
Sites / Locations
- Research centre for digital mental health services, Haukeland University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mobile application
Arm Description
A six weeks, rule-based chatbot intervention
Outcomes
Primary Outcome Measures
Revised Child Anxiety and Depression Scale -47 - Self-report
anxiety and depressive symptoms, higher score indicates worse outcomes
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
Revised Child Anxiety and Depression Scale -47 - Parent version
parent-reported anxiety and depressive symptoms, higher score indicates worse outcomes
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
Secondary Outcome Measures
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
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
Full Information
NCT ID
NCT05758935
First Posted
January 17, 2023
Last Updated
September 22, 2023
Sponsor
Haukeland University Hospital
Collaborators
The Research Council of Norway
1. Study Identification
Unique Protocol Identification Number
NCT05758935
Brief Title
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
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 27, 2023 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital
Collaborators
The Research Council of Norway
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
Adolescents, Anxiety, Chatbot intervention, Technology-delivered intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mobile application
Arm Type
Experimental
Arm Description
A six weeks, rule-based chatbot intervention
Intervention Type
Other
Intervention Name(s)
Rule-based chatbot intervention with therapist-guidance
Intervention Description
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.
Primary Outcome Measure Information:
Title
Revised Child Anxiety and Depression Scale -47 - Self-report
Description
anxiety and depressive symptoms, higher score indicates worse outcomes
Time Frame
assessing change from screening, pre, immediately after the intervention, follow-up 1 month, and at follow-up 3 months
Title
Revised Child Anxiety and Depression Scale - 25 - Self-report
Description
short version of RCADS-47, measuring anxiety and depressive symptoms, with a higher score indicating worse symptoms
Time Frame
assessing change from week 2, and week 4
Title
Revised Child Anxiety and Depression Scale -47 - Parent version
Description
parent-reported anxiety and depressive symptoms, higher score indicates worse outcomes
Time Frame
assessing change from pre, immediately after the intervention, follow-up 1 month, and at follow-up 3 months
Title
Revised Child Anxiety and Depression Scale - 25 - Parent version
Description
parent-reported, short version of RCADS-47, measuring anxiety and depressive symptoms, with a higher score indicating worse symptoms
Time Frame
assessing change from week 2, and week 4
Secondary Outcome Measure Information:
Title
Strengths and Difficulties Questionnaire - Youth version
Description
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
Time Frame
assessing change from pre, immediately after the intervention, follow up 1 month, and at follow-up 3 months
Title
Strengths and Difficulties Questionnaire - Parent version
Description
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
Time Frame
assessing change from pre, immediately after the intervention, follow up 1 month, and at follow-up 3 months
Other Pre-specified Outcome Measures:
Title
Motivation Questionnaire
Description
assessments of their motivation to participate in the intervention, developed specifically for this study
Time Frame
week 2
Title
Evaluation Questionnaire
Description
evaluation assessments of the intervention, developed specifically for this study.
Time Frame
immediately after the intervention
Title
Demographics
Description
gender, age
Time Frame
pre-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Smiti Kahlon, PhD
Phone
+4798866640
Email
smiti.kahlon@helse-bergen.no
First Name & Middle Initial & Last Name or Official Title & Degree
Tine Nordgreen, PhD
Phone
+4790094913
Email
tine.nordgreen@helse-bergen.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Smiti Kahlon, PhD
Organizational Affiliation
Haukeland University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research centre for digital mental health services, Haukeland University Hospital
City
Bergen
State/Province
Vestland
ZIP/Postal Code
5009
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Smiti Kahlon, PhD
Phone
004798866640
Email
smiti.kahlon@helse-bergen.no
First Name & Middle Initial & Last Name & Degree
Tine Nordgreen, PhD
Email
tine.nordgreen@helse-bergen.no
First Name & Middle Initial & Last Name & Degree
Smiti Kahlon, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Feasibility and Pilot Study of a Rule-based Chatbot Application for Adolescents With Anxiety Symptoms
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