Digital CBT for Insomnia in Older Surgical Patients

(SLEEP-BOOST Trial)

Overseen By Andrea Castillo, BS

Age: 65+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Massachusetts General Hospital

Disqualifiers: Psychosis, Suicidal ideation, Dementia, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The Sleep Optimization for Brain Health Outcomes in Older Surgical Patients (SLEEP-BOOST) is a pilot randomized, controlled, singled-blinded (participant) trial in major orthopedic joint surgery patients that will build on a previously clinically tested cognitive behavioral therapy for insomnia (CBT-I) mobile application paired with a wearable device (wrist actigraphy).

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that your sleep-affecting medications have been stable for the past month.

What data supports the effectiveness of the treatment Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) in older surgical patients?

Research shows that Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) is effective in improving sleep quality and reducing insomnia symptoms in various populations. It also enhances overall health, psychological well-being, and quality of life by addressing the daytime consequences of poor sleep. ^{1 2 3 4 5}

Is digital cognitive behavioral therapy for insomnia safe for humans?

The research does not specifically address safety concerns, but digital cognitive behavioral therapy for insomnia (dCBT-I) has been studied in many trials and is recommended as a first-line treatment, suggesting it is generally considered safe. ^{1 2 3 5 6}

How is the treatment Digital CBT for Insomnia different from other treatments for insomnia?

Digital CBT for Insomnia is unique because it is a scalable, digital therapy that can be accessed through a smartphone or computer, making it more convenient and accessible than traditional in-person therapy. It focuses on improving sleep quality and overall well-being without the need for medication, which can have side effects. ^{1 2 3 4 6}

Research Team

Lei Gao, MD

Principal Investigator

Mass. General Hospital

Eligibility Criteria

This trial is for older adults undergoing major joint surgery who may have sleep issues like insomnia or are at risk of postoperative cognitive complications. Participants should be willing to use a mobile app paired with a wearable device.

Inclusion Criteria

I am scheduled for a knee or hip replacement and will stay in the hospital for at least 2 days.

Own a smart phone

I am 65 years old or older.

Exclusion Criteria

Rapidly progressive illnesses/life expectancy <6 months

I have undergone or am currently undergoing cognitive behavioral therapy for insomnia.

I have a sleep disorder that is not insomnia or apnea.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Intervention

Participants receive preoperative digital CBT-I with the CBT-I Coach app and up to 4 weekly sessions

4 weeks

4 visits (virtual)

Postoperative Monitoring

Participants are monitored for circadian rest-activity rhythms, anxiety, function, insomnia severity, mood, and postoperative delirium

3 months

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Treatment Details

Interventions

• Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) (Behavioral Intervention)
• Sleep Health Education (Other)

Trial Overview The study tests if digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) via an app, along with wearing a wrist device that tracks activity, can improve brain health outcomes after surgery compared to just receiving sleep health education.

Participant Groups

Group I: Digital CBT-I Experimental Treatment 1 Intervention

Preoperative digital CBT-I with the CBT-I Coach app and up to 4 weekly sessions

Group II: Sleep Health Education Active Control 1 Intervention

Preoperative sleep health education materials

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Findings from Research

Digital cognitive behavior therapy for insomnia (dCBT-I) significantly improves sleep quality in patients with insomnia, particularly in those with anxiety disorders, as shown in a study of 6,002 patients over a 12-week period.

Patients receiving dCBT-I monotherapy and those with combined therapy showed notable improvements in sleep quality, with the most significant changes observed in the anxiety group, indicating that dCBT-I is a practical and effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital cognitive behavior therapy for insomnia improving sleep quality: a real-world study. Liang, S., Mao, H., Yang, J., et al.[2022]

Digital cognitive behavioral therapy (dCBT) significantly improves functional health, psychological well-being, and sleep-related quality of life in individuals with insomnia, based on a study of 1711 participants over 24 weeks.

The reduction in insomnia symptoms was a key factor mediating these improvements, highlighting that dCBT effectively addresses both daytime and nighttime issues related to poor sleep.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Digital Cognitive Behavioral Therapy for Insomnia on Health, Psychological Well-being, and Sleep-Related Quality of Life: A Randomized Clinical Trial. Espie, CA., Emsley, R., Kyle, SD., et al.[2023]

In a study involving 1720 adults with insomnia, digital cognitive behavioral therapy for insomnia (dCBT-I) significantly reduced intraindividual variability in sleep metrics, particularly in sleep onset latency, which is crucial for improving sleep quality.

The reduction in variability in sleep metrics was found to mediate significant improvements in both insomnia severity and psychological distress, highlighting the effectiveness of dCBT-I as a therapeutic intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of sleep-wake intraindividual variability in digital cognitive behavioral therapy for insomnia: a mediation analysis of a large-scale RCT. Vestergaard, CL., Vedaa, Ø., Simpson, MR., et al.[2021]

A smartphone-based, culturally adapted digital cognitive behavioral therapy for insomnia (DCBT-I) significantly reduced insomnia severity compared to sleep education in a randomized trial with 82 participants over 6 weeks.

Participants in the DCBT-I group experienced greater improvements in total sleep time and sleep efficiency at both 3 and 6 months follow-up, indicating its efficacy in enhancing sleep quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Cognitive Behavioral Therapy for Insomnia Using a Smartphone Application in China: A Pilot Randomized Clinical Trial. Zhang, C., Liu, Y., Guo, X., et al.[2023]

Digital cognitive behavioral therapy for insomnia (dCBT-I) was found to be more effective than medication alone in reducing insomnia symptoms, with significant improvements in Pittsburgh Sleep Quality Index scores over 6 months for dCBT-I and combination therapy.

While dCBT-I showed comparable effectiveness to combination therapy, its benefits were less stable over time, indicating that while it is a strong treatment option, further research is needed to understand its long-term reliability in different patient groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Effectiveness of Digital Cognitive Behavioral Therapy vs Medication Therapy Among Patients With Insomnia. Lu, M., Zhang, Y., Zhang, J., et al.[2023]

Digital cognitive behavioral therapy (dCBT) significantly improves functional health, psychological well-being, and sleep-related quality of life in adults with chronic insomnia, with these benefits sustained up to 48 weeks after treatment.

dCBT also reduces the use of both prescription and non-prescription sleep medications compared to sleep hygiene education, indicating its effectiveness in managing insomnia without relying heavily on medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term benefits of digital cognitive behavioural therapy for insomnia: Follow-up report from a randomized clinical trial. Luik, AI., Marsden, A., Emsley, R., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Digital cognitive behavior therapy for insomnia improving sleep quality: a real-world study. [2022]

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

Effect of Digital Cognitive Behavioral Therapy for Insomnia on Health, Psychological Well-being, and Sleep-Related Quality of Life: A Randomized Clinical Trial. [2023]

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

The effect of sleep-wake intraindividual variability in digital cognitive behavioral therapy for insomnia: a mediation analysis of a large-scale RCT. [2021]

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

Digital Cognitive Behavioral Therapy for Insomnia Using a Smartphone Application in China: A Pilot Randomized Clinical Trial. [2023]

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

Comparative Effectiveness of Digital Cognitive Behavioral Therapy vs Medication Therapy Among Patients With Insomnia. [2023]

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

Long-term benefits of digital cognitive behavioural therapy for insomnia: Follow-up report from a randomized clinical trial. [2021]