Sleep Chatbot for Insomnia

Overseen By Xiaopeng Ji, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Delaware

Must not be taking: Sleep medications

Disqualifiers: Depression, Obstructive apnea, Alcohol abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

24 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests an AI sleep chatbot that uses therapy techniques to help young Black/African American adults with poor sleep and metabolic issues. The chatbot offers personalized tips to improve sleep by changing bedtime habits and thoughts about sleep.

Will I have to stop taking my current medications?

The trial excludes people who regularly use medications that significantly affect sleep and cardio-metabolic markers, so you may need to stop taking such medications to participate.

What data supports the effectiveness of the Sleep Chatbot Intervention treatment for insomnia?

Research shows that digital cognitive behavioral therapy for insomnia (CBT-I), which the Sleep Chatbot Intervention is based on, can improve sleep by increasing total sleep time and sleep efficiency, and reducing the time it takes to fall asleep and wake after sleep onset. These digital therapies have shown favorable treatment effects, although they face challenges like high dropout rates. ^{1 2 3 4 5}

Is the Sleep Chatbot for Insomnia safe for humans?

The research does not provide specific safety data for the Sleep Chatbot for Insomnia, but similar digital cognitive behavioral therapy for insomnia (CBT-I) tools have been used without reported safety concerns. ^{2 4 6 7 8}

How is the Sleep Chatbot Intervention treatment different from other insomnia treatments?

The Sleep Chatbot Intervention is unique because it uses an artificial intelligence chatbot to deliver cognitive behavioral therapy for insomnia (CBT-I), making it more accessible and potentially more engaging than traditional face-to-face therapy. This digital approach can reach a larger number of patients at a lower cost and offers the convenience of being available anytime, which is not possible with in-person therapy. ^{1 2 4 7 8}

Research Team

Xiaopeng Ji, PhD

Principal Investigator

University of Delaware

Eligibility Criteria

This trial is for Black/African American adults aged 18-25 with at least one metabolic syndrome factor and poor sleep, owning a smartphone. Excluded are those with certain medical conditions, shift workers, diagnosed sleep apnea, regular users of sleep-affecting meds, smokers, heavy alcohol users, or pregnant/lactating individuals.

Inclusion Criteria

Criterion: You identify yourself as Black or African American.

I have at least one metabolic syndrome factor confirmed by a blood test.

Own a smartphone (iPhone or Android)

Exclusion Criteria

You smoke cigarettes.

You are pregnant or breastfeeding.

I have been diagnosed with sleep apnea that blocks my breathing.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a four-week intervention delivered through a chatbot using CBT-I principles, including personalized behavioral prescriptions and sleep schedule modifications.

4 weeks

Self-administered, ongoing interaction with chatbot

Follow-up

Participants are monitored for changes in sleep beliefs, chronotype, total sleep time, sleep efficiency, intra-individual variability in midsleep times, insomnia severity, metabolic health, and daytime sleepiness.

4 weeks

Treatment Details

Interventions

• Sleep Chatbot Intervention

Trial Overview The study tests an AI-powered sleep chatbot designed using cognitive-behavioral therapy guidelines to improve sleep in young Black/African American adults who may be at risk for heart and metabolic issues due to poor sleeping patterns.

Participant Groups

Group I: sleep chatbot intervention Experimental Treatment 1 Intervention

Using CBT-I principles, participants will receive a four-week intervention delivered through a chatbot. The self-administered intervention is comprised of personalized behavioral prescriptions based on stimulus control principles and sleep schedule modification goals using sleep efficiency (SE) criteria. Participants are allowed to self-adjust expectations and make realistic decisions on sleep schedules. Other CBT-I components will be used as on-demand content. The chatbot will facilitate sleep goal setting with the participant, communicate weekly behavioral prescription and CBT-I educational modules, collect sleep diary and provide adaptive feedback and reactive services (e.g. Q\&A conversations) 24/7.

Who Is Running the Clinical Trial?

University of Delaware

Lead Sponsor

Trials

167

Recruited

25,700+

National Institute of General Medical Sciences (NIGMS)

Collaborator

Trials

315

Recruited

251,000+

Findings from Research

A study involving 75 participants with insomnia disorder showed that an interactive online cognitive behavioral therapy (CBT-i) significantly improved sleep efficiency and sleep latency, indicating its efficacy as a treatment option.

Rigorous screening revealed that 62% of those who accessed the therapy had other sleep disorders, highlighting the importance of proper assessment before starting treatment to ensure effective outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot evaluation of an online cognitive behavioral therapy for insomnia disorder - targeted screening and interactive Web design lead to improved sleep in a community population. Anderson, KN., Goldsmith, P., Gardiner, A.[2021]

Cognitive behavioral therapy for insomnia (CBT-I) is the preferred treatment for insomnia, but its use is limited due to a shortage of trained therapists and high costs, leading to the development of Internet and mobile versions of CBT-I.

While digital CBT-I has shown promising results, challenges such as high dropout rates and the need for more advanced technology for fully automated solutions remain, highlighting the need for further research and development in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Insomnia in the Digital Age. Kang, SG., Kim, YK.[2020]

A network meta-analysis of 54 randomized controlled trials with 11,815 participants found that web-based cognitive behavioral therapy for insomnia (CBTi) with a therapist significantly improves total sleep time, reduces sleep onset latency, and decreases wake after sleep onset compared to usual care.

Web-based CBTi with therapists was ranked as the most effective treatment for insomnia, indicating it is the optimal intervention for enhancing sleep duration and efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative efficacy of digital cognitive behavioral therapy for insomnia: A systematic review and network meta-analysis. Hasan, F., Tu, YK., Yang, CM., et al.[2022]

Before the release of the CBT-I Coach app, 87% of VA-trained clinicians believed it could improve insomnia treatment and intended to use it, indicating strong initial support for the app's potential benefits.

Two years post-release, nearly 60% of clinicians reported using the app with patients, noting positive effects on homework adherence and treatment outcomes, suggesting that the app effectively supports cognitive behavioral therapy for insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CBT-I Coach: A Description and Clinician Perceptions of a Mobile App for Cognitive Behavioral Therapy for Insomnia. Kuhn, E., Weiss, BJ., Taylor, KL., et al.[2018]

In a study of 101 adults undergoing cognitive behaviour therapy for insomnia (CBT-I), both pre-intervention expectations and post-intervention difficulties in applying the therapy were found to significantly predict treatment outcomes at 9 weeks and 6 months.

Face-to-face (FtF) therapy showed a stronger association with positive outcomes at 9 weeks compared to digital CBT-I, but this advantage diminished by the 6-month follow-up, suggesting that self-confidence in using sleep restriction techniques is crucial for long-term success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using network intervention analysis to explore associations between participant expectations of and difficulties with cognitive behavioural therapy for insomnia and clinical outcome: A proof of principle study. Scott, J., Vedaa, Ø., Sivertsen, B., et al.[2022]

A survey of 108 Veterans Affairs-trained clinicians revealed that 50% used the CBT-I Coach app for cognitive-behavioral therapy for insomnia, with 98% of users intending to continue its use, indicating strong acceptance and perceived utility in enhancing patient engagement and compliance.

Clinicians who used the app found it less complex and more compatible with their practice compared to nonusers, although barriers such as patient access to smartphones and lack of awareness hindered broader adoption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinician Perceptions Related to the Use of the CBT-I Coach Mobile App. Miller, KE., Kuhn, E., Owen, JE., et al.[2022]

The digital Brief Therapy for Insomnia (dBTI) platform, developed during the COVID-19 pandemic, showed that 68% of participants completed over half of the course, indicating good adherence to the online treatment.

Higher adherence to the dBTI program was associated with significant improvements in insomnia severity and pre-sleep arousal, suggesting that this digital approach can effectively help individuals manage acute insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The platform development, adherence and efficacy to a digital Brief therapy for insomnia (dBTI) during the COVID-19 pandemic. Liu, X., Li, Y., Yan, R., et al.[2023]

A study involving 95 adults with chronic insomnia found that fully automated Internet-delivered cognitive behavioral therapy for insomnia (CBT-I) led to significant improvements in sleep quality and daytime functioning, which were maintained 18 months after the intervention.

Participants showed large effect size improvements in insomnia severity, daytime fatigue, and beliefs about sleep, indicating that unguided Internet CBT-I can provide lasting benefits for individuals struggling with insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Effects of an Unguided Online Cognitive Behavioral Therapy for Chronic Insomnia. Vedaa, Ø., Hagatun, S., Kallestad, H., et al.[2020]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

A pilot evaluation of an online cognitive behavioral therapy for insomnia disorder - targeted screening and interactive Web design lead to improved sleep in a community population. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Insomnia in the Digital Age. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Comparative efficacy of digital cognitive behavioral therapy for insomnia: A systematic review and network meta-analysis. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

CBT-I Coach: A Description and Clinician Perceptions of a Mobile App for Cognitive Behavioral Therapy for Insomnia. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Using network intervention analysis to explore associations between participant expectations of and difficulties with cognitive behavioural therapy for insomnia and clinical outcome: A proof of principle study. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Clinician Perceptions Related to the Use of the CBT-I Coach Mobile App. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

The platform development, adherence and efficacy to a digital Brief therapy for insomnia (dBTI) during the COVID-19 pandemic. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Long-Term Effects of an Unguided Online Cognitive Behavioral Therapy for Chronic Insomnia. [2020]