Web-based Sleep Interventions for Caregiver Insomnia

(NiteCAPP Trial)

Recruiting at 1 trial location

Overseen By Christina S McCrae

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Missouri-Columbia

Must not be taking: Psychotropics, Beta-blockers

Disqualifiers: Cognitive impairment, Sleep apnea, Bipolar, others

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

Compensation: Varies

Number of Visits: 6

Duration: 8 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this project evaluate the efficacy of NiteCAPP in improving insomnia in a rural dementia caregiver sample (n of 100 caregiver and PWD dyads). We will measure both the short term (post-treatment) and long term (6 and 12 months) effects of the intervention on CG sleep, arousal, inflammation, health, mood, burden and cognitive function, and PWD sleep.

Will I have to stop taking my current medications?

If you are taking sleep medications, you must have been off them for at least one month or have been on a stable dose for six months to participate. Other medications that affect sleep, like certain psychotropic drugs or beta-blockers, may also need to be stopped.

What data supports the effectiveness of the treatment NiteCAPP CARE, NiteCAPP CARES, NiteCAPP SHARES, and similar treatments for caregiver insomnia?

Research shows that online cognitive behavioral therapy for insomnia (CBT-i) can improve sleep efficiency and reduce insomnia severity. Digital health technologies, like smartphone apps, have been effective in delivering these therapies remotely, making them accessible and engaging for users. ^{1 2 3 4 5}

Is the web-based sleep intervention NiteCAPP safe for humans?

The research does not provide specific safety data for NiteCAPP, but web-based cognitive behavioral therapy for insomnia (CBT-I) is generally considered safe for humans, as it is a non-invasive treatment focusing on improving sleep habits and behaviors. ^{2 3 4 6 7}

What makes the NiteCAPP treatment unique for caregiver insomnia?

NiteCAPP is a web-based cognitive behavioral therapy for insomnia (CBT-I) that offers a convenient and scalable way to deliver therapy to caregivers experiencing insomnia, making it accessible to a large number of people at a lower cost compared to traditional in-person therapy. ^{1 2 4 8 9}

Research Team

Christina S McCrae

Principal Investigator

University of South Florida

Eligibility Criteria

This trial is for adult caregivers living with someone who has dementia and insomnia. Caregivers must have their own insomnia diagnosis, not be on recent sleep meds, and read English. The person with dementia must also suffer from insomnia but can't be on new sleep meds or have untreated sleep disorders like severe apnea.

Inclusion Criteria

I have had trouble sleeping for over 6 months, affecting my daily life.

PWD Eligibility: 1. probable/possible Alzheimer's Disease (self-report or primary care provider written confirmation), 2. experiencing 1+ problem on Nighttime Behavior Inventory 3+ nights per week, 3. able to tolerate actigraphy, 4. not taking sleep medications for 1+ month or stabilized for 6+ months, 5. untreated sleep disorder for which Cognitive Behavioral Therapy for Insomnia (CBT-I) is not recommended (e.g., apnea), 6. scoring <32 on Sleep Apnea scale, Sleep Disorders Questionnaire

Exclusion Criteria

CG Exclusion criteria: 1. unable to consent, 2. cognitive impairment (Telephone Interview for Cognitive Status (TICS) score <25), 3. sleep disorder other than insomnia (e.g., apnea with apnea/hypopnea index-AHI >15), 4. bipolar or seizure disorder, 5. other major psychopathology except depression or anxiety (e.g., suicidal, psychotic), 6. severe untreated psychiatric comorbidity, 7. taking psychotropic or other medications (e.g., beta-blockers) that alter sleep, 8. receiving non-pharmacological treatment for sleep or mood outside current trial.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the NiteCAPP web-based intervention, which includes 4 weekly sessions and 4 bimonthly booster sessions.

8 weeks

Sessions completed individually online

Follow-up

Participants are monitored for long-term effects on sleep, arousal, inflammation, health, mood, burden, and cognitive function.

12 months

Assessments at 6 and 12 months

Treatment Details

Interventions

• NiteCAPP CARE
• NiteCAPP CARES
• NiteCAPP SHARE
• NiteCAPP SHARES

Trial Overview The NiteCAPP study tests two web-based programs (CARES & SHARES) designed to help rural caregivers of dementia patients manage insomnia. It looks at how well these programs work right after treatment and checks again after 6 and 12 months for any changes in the caregiver's sleep, health, mood, stress levels, and cognitive function.

Participant Groups

Group I: NiteCAPP SHARES Experimental Treatment 1 Intervention

Sleep Hygiene and Related Education. Web-based intervention that will include 4 weekly sessions and 4 bimonthly boosters. Each session is to be completed individually by CG (with PWD to extent able) in a single sitting (less than 45 mins). Each session should be completed in 7 days with next session released only after prior one completed. Session 1 focuses on expanded sleep education and sleep hygiene. Session 2 focuses insomnia education and sleep hygiene support. Session 3 focuses on targeted sleep education and sleep in dementia. Session 4 focuses on a review of skills and plan for maintenance of behavior change. Boosters review skills, encourage practice, and troubleshoot issues.

Group II: NiteCAPP CARES Experimental Treatment 1 Intervention

Cognitive Behavioral Treatment-Insomnia. Web-based intervention that will include 4 weekly sessions and 4 bimonthly boosters. Each session is to be completed individually by CG (with PWD to extent able) in a single sitting (less than 45 mins). Each session should be completed in 7 days with next session released only after prior one completed. Session 1 focuses on sleep education, sleep hygiene, and stimulus control. Session 2 focuses on sleep compression, relaxation, and problem solving. Session 3 focuses on coping and stress management and cognitive therapy. Session 4 focuses on a review of skills and plan for maintenance of behavior change.

NiteCAPP CARE is already approved in United States for the following indications:

Approved in United States as NiteCAPP CARES for:

• Insomnia in rural dementia caregivers

Who Is Running the Clinical Trial?

University of Missouri-Columbia

Lead Sponsor

Trials

387

Recruited

629,000+

University of South Florida

Lead Sponsor

Trials

433

Recruited

198,000+

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]

The Nitra application, an internet-based cognitive behavioral therapy for insomnia (CBT-i), significantly improved sleep efficiency and various sleep parameters in 40 adults with chronic subthreshold to moderate insomnia over a 4-week intervention period.

Participants who adhered closely to the recommended sleep schedule showed a higher likelihood of achieving normal sleep efficiency, highlighting the importance of consistent sleep habits in managing insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of internet-based CBT-I for the treatment of chronic subthreshold to moderate insomnia. Theppornpitak, W., Hemrungrojn, S., Thienwiwatnukul, K., et al.[2023]

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]

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 KANOPEE app significantly improved insomnia symptoms more than the My Sleep Diary app, with users reporting a greater reduction in Insomnia Severity Index scores after 17 days of use.

KANOPEE users also experienced a notable increase in total sleep time, gaining an average of 48 minutes of sleep compared to just 16 minutes for My Sleep Diary users, especially benefiting those with moderate to severe insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a Smartphone-Based Virtual Companion to Treat Insomniac Complaints in the General Population: Sleep Diary Monitoring Versus an Internet Autonomous Intervention. Philip, P., Dupuy, L., Sagaspe, P., et al.[2023]

The study successfully adapted a digital cognitive behavioral therapy for insomnia (CBT-I) program, called NiteCAPP CARES, specifically for rural dementia caregivers, incorporating feedback from both caregivers and healthcare providers to enhance usability and relevance.

Pilot testing of NiteCAPP CARES showed promising preliminary effects on improving sleep and related health outcomes for caregivers, with high ratings for usefulness and satisfaction, indicating its potential as a feasible intervention for this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Initial Evaluation of Web-Based Cognitive Behavioral Therapy for Insomnia in Rural Family Caregivers of People With Dementia (NiteCAPP): Mixed Methods Study. McCrae, CS., Curtis, AF., Stearns, MA., et al.[2023]

The CBT-i Coach mobile app significantly improved subjective sleep outcomes in veterans, with participants reporting reduced insomnia and better sleep quality after a 6-week intervention, despite a decrease in objective sleep time.

The study highlights the importance of using both subjective and objective sleep measures, as the objective data revealed a decrease in sleep time and no changes in REM sleep or sleep efficiency, suggesting potential undiagnosed sleep apnea in participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile App Use for Insomnia Self-Management: Pilot Findings on Sleep Outcomes in Veterans. Reilly, ED., Robinson, SA., Petrakis, BA., et al.[2020]

A web-based training course for Cognitive Behavioral Therapy for Insomnia (CBT-I), called CBTIweb.org, was developed and evaluated, showing high usability and significant knowledge gains among participants, with a knowledge increase from 69% to 92% correct after training.

The effectiveness of CBTIweb.org was found to be equivalent to traditional in-person workshops, suggesting it can effectively train behavioral health providers in CBT-I, thus addressing the shortage of trained professionals and allowing for broader access to insomnia treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing and Testing a Web-Based Provider Training for Cognitive Behavioral Therapy of Insomnia. Taylor, DJ., Dietch, JR., Pruiksma, K., et al.[2021]

Digital cognitive behavioral therapy (CBT) for insomnia shows promise as a scalable first-line treatment, but only about half of patients experience full remission, highlighting the importance of treatment engagement.

Key facilitators for engagement include the enjoyment of interactive elements and clear content, while barriers often stem from a need for more human support and challenges related to health and technological literacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient perspectives on facilitators and barriers to equitable engagement with digital CBT-I. Cheng, P., Santarossa, S., Kalmbach, D., et al.[2023]

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. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of internet-based CBT-I for the treatment of chronic subthreshold to moderate insomnia. [2023]

3. 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]

4. England pubmed.ncbi.nlm.nih.gov

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

5. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy of a Smartphone-Based Virtual Companion to Treat Insomniac Complaints in the General Population: Sleep Diary Monitoring Versus an Internet Autonomous Intervention. [2023]

6. Canada pubmed.ncbi.nlm.nih.gov

Development and Initial Evaluation of Web-Based Cognitive Behavioral Therapy for Insomnia in Rural Family Caregivers of People With Dementia (NiteCAPP): Mixed Methods Study. [2023]

7. Canada pubmed.ncbi.nlm.nih.gov

Mobile App Use for Insomnia Self-Management: Pilot Findings on Sleep Outcomes in Veterans. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Developing and Testing a Web-Based Provider Training for Cognitive Behavioral Therapy of Insomnia. [2021]

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

Patient perspectives on facilitators and barriers to equitable engagement with digital CBT-I. [2023]