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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests web-based programs designed to help caregivers of people with dementia improve their sleep. The study examines two approaches: one focuses on cognitive behavioral techniques, such as relaxation and problem-solving, while the other emphasizes sleep hygiene and education. These programs, called NiteCAPP CARE and NiteCAPP SHARE, aim to assess their impact on caregivers' sleep, mood, overall health, and the sleep of the person they care for. Suitable participants are caregivers living with someone with dementia who have experienced insomnia for more than six months without using sleep medications. As an unphased trial, this study provides caregivers the chance to explore innovative solutions for enhancing sleep and overall well-being.

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 prior data suggests that these web-based sleep interventions are safe for caregivers?

Research has shown that online cognitive behavioral therapy for insomnia, such as NiteCAPP CARES and NiteCAPP SHARES, is generally safe. Although specific safety data for NiteCAPP is not available, this therapy type typically has few or no side effects. Most individuals tolerate it well because it focuses on changing sleep habits rather than using medications, resulting in a low risk of negative effects. Prospective participants should know that these programs are designed to be user-friendly and aim to improve sleep without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these web-based interventions for caregiver insomnia because they offer a fresh approach compared to traditional methods like medication or in-person cognitive behavioral therapy (CBT). NiteCAPP CARES combines cognitive behavioral techniques with online accessibility, allowing caregivers to complete sessions at their convenience while focusing on sleep education, relaxation, and stress management. NiteCAPP SHARES also leverages the convenience of web-based delivery, emphasizing practical sleep hygiene education and support, tailored for those caring for individuals with dementia. These interventions not only provide flexibility and accessibility but also empower caregivers with skills to manage their sleep challenges effectively.

What evidence suggests that this trial's treatments could be effective for caregiver insomnia?

Research has shown that online programs like NiteCAPP CARES and NiteCAPP SHARES, studied in this trial, can improve insomnia. These treatments are particularly beneficial for caregivers in rural areas who lack easy access to in-person therapy. The programs use cognitive behavioral therapy (a type of talk therapy that helps change negative thinking) and sleep education to manage sleep issues. Early results suggest these online programs not only improve sleep in the short term but may also offer lasting benefits for mood, stress, and overall health. ^{2 3 6 7 8}

Who Is on the Research Team?

Christina S McCrae

Principal Investigator

University of South Florida

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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 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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10485710/

Development and Initial Evaluation of Web-Based Cognitive ... Web-based delivery promises to improve insomnia, particularly for rural caregivers who have limited access to traditional in-person treatments.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04896775

NiteCAPP: Web-based Interventions for Insomnia in Rural ... 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).

3. aging.jmir.org aging.jmir.org/2023/1/e45859/

Development and Initial Evaluation of Web-Based Cognitive ... Web-based delivery promises to improve insomnia, particularly for rural caregivers who have limited access to traditional in-person treatments.

4. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/287901

NiteCAPP: Web-based Interventions for Insomnia in Rural ... The goal of this project evaluate the efficacy of NiteCAPP in improving insomnia in a rural dementia caregiver sample (n of 100 caregiver ...

5. researchprotocols.org researchprotocols.org/2022/6/e37874/

Impact of Web-Based Cognitive Behavioral Therapy for ... This trial will evaluate the acceptability, feasibility, and short-term and long-term effects of NiteCAPP CARES on the sleep and stress mechanisms underlying ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9240954/

Impact of Web-Based Cognitive Behavioral Therapy ... This trial will evaluate the acceptability, feasibility, and short-term and long-term effects of NiteCAPP CARES on the sleep and stress mechanisms underlying ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35700020/

Impact of Web-Based Cognitive Behavioral Therapy ... - PubMed This trial will evaluate the acceptability, feasibility, and short-term and long-term effects of NiteCAPP CARES on the sleep and stress mechanisms underlying ...

8. withpower.com withpower.com/trial/phase-dementia-7-2021-5fa67?fbclid=IwZXh0bgNhZW0CMTEAAR53bvSjIZA8h6UxH7aml1SUFUiqF3p9_WWXZzPg78qRaJLUkfLdDNr_FW0qdQ_aem_RvJnUYRkJIZOR2rucpp6RQ

Web-based Sleep Interventions for Caregiver Insomnia The research does not provide specific safety data for NiteCAPP, but web-based cognitive behavioral therapy for insomnia (CBT-I) is generally considered safe ...