CBT-I Chatbot for Youth

February 10, 2025 updated by: Tim M. H. Li, Chinese University of Hong Kong

Efficacy of a Chatbot to Deliver Cognitive-behavioral Therapy for Insomnia in Youth: a Randomized Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention group
Behavioral: Cognitive Behavioral Therapy for Insomnia in Chatbot
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.
No Intervention: Control group
Waitlist control

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Insomnia Severity Index (ISI)
Time Frame: 10-20 minutes
The Insomnia Severity Index (ISI) will be used to measure insomnia symptoms in the previous month. ISI includes 7 items with a five-point Likert format (0 = not at all to 4 = very much). The total score ranges from 0 to 28. A score ≥ 8 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.
10-20 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The reduced Horne and Östberg Morningness and Eveningness Questionnaire (rMEQ)
Time Frame: 10-20 minutes
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.
10-20 minutes
The Patient Health Questionnaire-9 (PHQ-9)
Time Frame: 10-20 minutes
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.
10-20 minutes
Dysfunctional Beliefs and Attitudes about Sleep scale (DBAS-16)
Time Frame: 10-20 minutes
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.
10-20 minutes
Sleep Hygiene Index (SHI)
Time Frame: 10-20 minutes
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).
10-20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 6, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 3, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KPF22GWP14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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