RCT of CBT-I Chatbot
Primary Purpose
Insomnia
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy for Insomnia in Chatbot
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia focused on measuring Chatbot, Youth, Insomnia, CBT-I, RCT
Eligibility Criteria
Inclusion Criteria: score 8 or higher on the Insomnia Severity Index (ISI) between 18 and 35 years old read and type Chinese own a smartphone have consistent internet access to their smartphone Exclusion Criteria: have a self-reported diagnosis of any psychiatric disorder(s) have been on regular medication(s) in the past month do not have instant messaging app(s) will be excluded.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
Waitlist control
Outcomes
Primary Outcome Measures
The Insomnia Severity Index (ISI)
The Insomnia Severity Index (ISI) will be used to measure insomnia symptoms in the previous month. ISI includes 7 items with five-point Likert format (0 = not at all to 4 = very much). The total score ranges from 0 to 28. A score ≥ 9 indicates clinically significant insomnia in Chinese adolescents (sensitivity = 87%, specificity = 75%). The Cronbach's alpha and the test-retest reliability of ISI were 0.83 and 0.79, respectively.
Secondary Outcome Measures
The reduced Horne and Östberg Morningness and Eveningness Questionnaire (rMEQ)
The reduced Horne and Östberg Morningness and Eveningness Questionnaire (rMEQ) was used to measure chronotype preference. rMEQ consists of 5 items where the first 4 items were scored from 1 to 5 while the last item was scored from 0 to 6. The total score ranged from 4 to 25. Three classified types of chronotype were eveningness (score < 12), intermediate-type (score 12-17), and morningness (score > 17). The Cronbach's alpha and the test-retest reliability of rMEQ were 0.70 and 0.77, respectively.
The Patient Health Questionnaire-9 (PHQ-9)
The Patient Health Questionnaire-9 (PHQ-9) will be used to measure depression symptoms in the past two weeks. PHQ-9 includes 9 items with a four-point Likert format (0 = not at all to 3 = nearly every day). The total score ranges from 0 to 27. A score ≥ 10 indicates clinically significant depression in Chinese population (sensitivity = 88%, specificity = 88%). The Cronbach's alpha and the test-retest reliability of PHQ-9 were 0.86 and 0.84, respectively.
Dysfunctional Beliefs and Attitudes about Sleep scale (DBAS-16)
Dysfunctional Beliefs and Attitudes about Sleep scale (DBAS-16) is a shortened version of the original DBAS, it will evaluate sleep-disruptive cognitions. DBAS-16 includes 16 items with a ten-point Likert format (0 = strongly disagree to 10 = strongly agree). The total score is based on the average score of all items. A higher score reflects greater dysfunctional beliefs about sleep. A Pearson correlation coefficient computed between the total scores showed a significant correlation, r(72) = 0.83, P <0.0001, suggesting adequate temporal stability. A paired t-test revealed that the total score of the DBAS-16 decreased significantly from the first (mean = 4.95, SD = 1.35) to the second (mean = 4.57, SD = 1.48) administration. Cronbach alpha values of 0.77 (clinical) and 0.79 (research) indicate adequate internal consistency.
Sleep Hygiene Index (SHI)
Sleep Hygiene Index (SHI) is used to assess sleep hygiene. Each item is rated on a five-point scale ranging from 0 (never) to 4 (always). Total scores range from 0 to 52, with a higher score representing poorer sleep hygiene. Cronbach's alpha = 0.66 and test-retest reliability (r = 0.71). Chinese version of SHI shows internal consistency (α = 0.62, ω = 0.63) and stability (test-retest reliability = 0.90).
Full Information
NCT ID
NCT05769231
First Posted
March 3, 2023
Last Updated
March 3, 2023
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT05769231
Brief Title
RCT of CBT-I Chatbot
Official Title
Efficacy of a Chatbot to Deliver Cognitive-behavioral Therapy for Insomnia in Youth: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 6, 2023 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Insomnia is prevalent in youth, and it associates with depression and other psychiatric disorders, leading to increased mental health burden. Cognitive Behavioral Therapy for Insomnia (CBT-I) is recommended as first-line treatment for insomnia. Digital tools have been employed to automate mental health interventions, in order to address deterrents such as clinician shortage, limited appointment availability, high cost, and stigma of seeking help. Digital CBT-I is shown to be effective in treating insomnia. Future digital intervention will incorporate patient-centered design, input from key stakeholders, and new understandings of behavior change. Artificial Intelligence (AI)-powered chatbots are utilized in different industries for better customer experience. AI chatbot is also utilized in the mental health industry to extend the boundary of digital interventions from accommodating didactic and informational content to providing interactive, intelligent, and most importantly, patient-centered conversational agents. Some famous AI mental health chatbots in Western societies were developed to give tailored feedback, respond to emotions that a user expresses, and encourage users to complete an intervention. This study will investigate the effect of a CBT-I chatbot on insomnia to provide further evidence on mental health chatbot.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
Chatbot, Youth, Insomnia, CBT-I, RCT
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
132 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Waitlist control
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy for Insomnia in Chatbot
Intervention Description
Digital interventions can relieve the worldwide burden of mental disorders. The low set-up costs and barriers of online platforms make digital interventions very cost-effective. By using the Internet as a delivery medium, many people can enjoy unrestricted access to self-help information. Unlike traditional face-to-face intervention, the effects of digital self-help interventions are scalable. The current study attempts to extend the boundary of digital interventions from accommodating didactic and informational content to providing interactive, intelligent, and most importantly, patient-centered conversational agents. AI chatbots can provide suitable recommendations and training materials to users according to their behavioral, mental, and motivational readiness. Since existing AI chatbots are developed for Western societies, a culture-specific Chinese chatbot will fill the research and service gaps.
Primary Outcome Measure Information:
Title
The Insomnia Severity Index (ISI)
Description
The Insomnia Severity Index (ISI) will be used to measure insomnia symptoms in the previous month. ISI includes 7 items with five-point Likert format (0 = not at all to 4 = very much). The total score ranges from 0 to 28. A score ≥ 9 indicates clinically significant insomnia in Chinese adolescents (sensitivity = 87%, specificity = 75%). The Cronbach's alpha and the test-retest reliability of ISI were 0.83 and 0.79, respectively.
Time Frame
10-20 minutes
Secondary Outcome Measure Information:
Title
The reduced Horne and Östberg Morningness and Eveningness Questionnaire (rMEQ)
Description
The reduced Horne and Östberg Morningness and Eveningness Questionnaire (rMEQ) was used to measure chronotype preference. rMEQ consists of 5 items where the first 4 items were scored from 1 to 5 while the last item was scored from 0 to 6. The total score ranged from 4 to 25. Three classified types of chronotype were eveningness (score < 12), intermediate-type (score 12-17), and morningness (score > 17). The Cronbach's alpha and the test-retest reliability of rMEQ were 0.70 and 0.77, respectively.
Time Frame
10-20 minutes
Title
The Patient Health Questionnaire-9 (PHQ-9)
Description
The Patient Health Questionnaire-9 (PHQ-9) will be used to measure depression symptoms in the past two weeks. PHQ-9 includes 9 items with a four-point Likert format (0 = not at all to 3 = nearly every day). The total score ranges from 0 to 27. A score ≥ 10 indicates clinically significant depression in Chinese population (sensitivity = 88%, specificity = 88%). The Cronbach's alpha and the test-retest reliability of PHQ-9 were 0.86 and 0.84, respectively.
Time Frame
10-20 minutes
Title
Dysfunctional Beliefs and Attitudes about Sleep scale (DBAS-16)
Description
Dysfunctional Beliefs and Attitudes about Sleep scale (DBAS-16) is a shortened version of the original DBAS, it will evaluate sleep-disruptive cognitions. DBAS-16 includes 16 items with a ten-point Likert format (0 = strongly disagree to 10 = strongly agree). The total score is based on the average score of all items. A higher score reflects greater dysfunctional beliefs about sleep. A Pearson correlation coefficient computed between the total scores showed a significant correlation, r(72) = 0.83, P <0.0001, suggesting adequate temporal stability. A paired t-test revealed that the total score of the DBAS-16 decreased significantly from the first (mean = 4.95, SD = 1.35) to the second (mean = 4.57, SD = 1.48) administration. Cronbach alpha values of 0.77 (clinical) and 0.79 (research) indicate adequate internal consistency.
Time Frame
10-20 minutes
Title
Sleep Hygiene Index (SHI)
Description
Sleep Hygiene Index (SHI) is used to assess sleep hygiene. Each item is rated on a five-point scale ranging from 0 (never) to 4 (always). Total scores range from 0 to 52, with a higher score representing poorer sleep hygiene. Cronbach's alpha = 0.66 and test-retest reliability (r = 0.71). Chinese version of SHI shows internal consistency (α = 0.62, ω = 0.63) and stability (test-retest reliability = 0.90).
Time Frame
10-20 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
score 8 or higher on the Insomnia Severity Index (ISI)
between 18 and 35 years old
read and type Chinese
own a smartphone
have consistent internet access to their smartphone
Exclusion Criteria:
have a self-reported diagnosis of any psychiatric disorder(s)
have been on regular medication(s) in the past month
do not have instant messaging app(s) will be excluded.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tim M. H. Li
Phone
852 39197749
Email
manholi@cuhk.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Framenia O. C. Law
Phone
852 39197792
Email
oonchuklaw@cuhk.edu.hk
12. IPD Sharing Statement
Plan to Share IPD
No
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RCT of CBT-I Chatbot
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