Digital CBT for Insomnia in Older Surgical Patients

(SLEEP-BOOST Trial)

Overseen By Andrea Castillo, BS

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Psychosis, Suicidal ideation, Dementia, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a digital therapy tool can improve sleep for older adults undergoing major joint surgery, such as hip or knee replacements. Participants will use a mobile app for digital cognitive behavioral therapy designed for insomnia (dCBT-I), paired with a wrist device to track sleep. The trial compares this digital therapy to traditional sleep health education. It suits those 65 and older who are having joint surgery, have mild insomnia, and are comfortable using a smartphone app. As an unphased trial, this study allows participants to contribute to innovative research that could enhance sleep therapy options for future patients.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that digital cognitive behavioral therapy for insomnia (dCBT-I) is generally safe. Studies have found that dCBT-I can improve sleep quality without major safety issues. For instance, one study reported that participants using dCBT-I experienced much better sleep over 8 and 24 weeks, with no serious side effects. Another study demonstrated that dCBT-I worked better than medication for long-term sleep improvement, indicating it is a well-tolerated option. Overall, dCBT-I appears to be a safe and effective way to enhance sleep quality. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) because it offers a unique, digital approach to treating insomnia, especially in older surgical patients. While traditional insomnia treatments often rely on medication or in-person therapy, dCBT-I utilizes the CBT-I Coach app to deliver therapy sessions directly to patients' devices. This digital delivery allows for greater accessibility and convenience, enabling patients to engage with therapy at their own pace, both preoperatively and postoperatively. The method not only makes cognitive behavioral therapy more widely available but also provides tailored booster sessions after surgery, potentially improving sleep outcomes more efficiently than standard treatments.

What evidence suggests that this trial's treatments could be effective for insomnia in older surgical patients?

Research has shown that digital Cognitive Behavioral Therapy for Insomnia (dCBT-I), which participants in this trial may receive, effectively treats insomnia. In one study, 60% of patients using dCBT-I experienced resolution of their insomnia symptoms, compared to only 16% who did not use it. This digital therapy reduces sleep problems and the need for sleep medications. Another study found that dCBT-I improved sleep and reduced stress by stabilizing sleep patterns. Overall, dCBT-I offers long-term benefits and is a promising option for improving sleep in older adults. Meanwhile, another group in this trial will receive Sleep Health Education, serving as an active comparator. ^{2 4 6 7 8}

Who Is on the Research Team?

Lei Gao, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

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

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.

How Is the Trial Designed?

Group I: Digital CBT-I Experimental Treatment 1 Intervention

Preoperative digital CBT-I with the CBT-I Coach app for up to 4 weekly sessions and postoperative booster sessions at 2 weeks and 1 month after surgery.

Group II: Sleep Health Education Active Control 1 Intervention

Preoperative sleep health education materials

Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) is already approved in United States, European Union for the following indications:

Approved in United States as Digital Cognitive Behavioral Therapy for Insomnia for:

• Insomnia
• Sleep disorders

Approved in European Union as Digital Cognitive Behavioral Therapy for Insomnia for:

• Insomnia
• Sleep disorders

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

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]

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 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]

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]

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]

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]

Citations

1. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2803668

Digital Cognitive Behavioral Therapy vs Medication ... In this study, clinical evidence suggested that combination therapy was optimal, and dCBT-I was more effective than medication therapy, with long-term benefits ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/?term=Efficacy+of+digital+cognitive+behavioral+therapy+for+treating+insomnia+in+adults+aged+65+and+older%3A+a+secondary+analysis+using+individual+participant+data+from+three+randomized+controlled+trials.

Efficacy of digital cognitive behavioral therapy for treating ... dCBT generated higher post-treatment insomnia remission rates (60% vs. 16%, p < 0.001). Conclusion: dCBT can effectively improve symptoms of insomnia, anxiety, ...

3. withpower.com withpower.com/trial/phase-neurocognitive-disorders-9-2024-e7d06

Digital CBT for Insomnia in Older Surgical Patients The reduction in variability in sleep metrics was found to mediate significant improvements in both insomnia severity and psychological distress, highlighting ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06593262?cond=Insomnia&aggFilters=status:enr&viewType=Table&rank=1

Efficacy of Digital Cognitive Behavioral Therapy for ... The project aims to conduct an assessor-blind, randomized controlled trial to evaluate the efficacy of an app-based CBT-I with AI chatbot in reducing insomnia ...

5. thelancet.com thelancet.com/journals/landig/article/PIIS2589-7500(20)30135-7/fulltext

Effects of digital cognitive behavioural therapy for insomnia ... Overall, the dCBT-I group achieved significantly better insomnia outcomes while reducing their reliance on sleep medication. Importantly, dCBT-I also reduced ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05541055

NCT05541055 | Digital CBT-I for Insomnia Disorder A fully-automated and personalized digital intervention based on principles from cognitive behavioral therapy for insomnia. Other Names: Sleepio. Participant ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12503573/

The Effects of Digital Cognitive Behavioral Therapy for ... The dCBT-I group showed large improvements in the severity of insomnia compared to the WLC both after 8 (−4.36, p < 0.001; d = −1.18) and 24 weeks (−4.88, p < ...

8. cureus.com cureus.com/articles/362542-the-effects-of-digital-based-cognitive-behavioral-therapy-for-insomnia-cbt-i-on-sleep-quality-in-shift-workers-a-scoping-review

The Effects of Digital-Based Cognitive Behavioral Therapy ... All studies showed improved sleep quality after the implementation of dCBT-I, except for one. Two studies suggest that dCBT-I is equally ...