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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
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Chatbot, Youth, Insomnia, CBT-I, RCT

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    March 3, 2023
    Last Updated
    March 3, 2023
    Sponsor
    Chinese University of Hong Kong
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    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

    Learn more about this trial

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