Web-based Sleep Interventions for Caregiver Insomnia
(NiteCAPP Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
CS
Overseen byChristina S McCrae
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Missouri-Columbia
Must not be taking: Psychotropics, Beta-blockers
Disqualifiers: Cognitive impairment, Sleep apnea, Bipolar, others
No Placebo Group
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?
Is the web-based sleep intervention NiteCAPP safe for humans?
What makes the NiteCAPP treatment unique for caregiver insomnia?
Research Team
CS
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
I am over 18, live with someone who has dementia, can read English, have insomnia, and haven't used sleep meds recently or have used them consistently for 6+ months.
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.
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 (Behavioural Intervention)
- NiteCAPP CARES (Behavioural Intervention)
- NiteCAPP SHARE (Behavioural Intervention)
- NiteCAPP SHARES (Behavioural Intervention)
Trial OverviewThe 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
2Treatment groups
Experimental Treatment
Group I: NiteCAPP SHARESExperimental Treatment1 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 CARESExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MissouriColumbia, MO
University of South FloridaTampa, FL
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Who Is Running the Clinical Trial?
University of Missouri-Columbia
Lead Sponsor
Trials
387
Patients Recruited
629,000+
University of South Florida
Lead Sponsor
Trials
433
Patients Recruited
198,000+
References
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]Computerized or online cognitive behavioral therapies (CBTs) are increasingly being developed to deliver insomnia therapy (CBT-i). They seek to address the difficulty of delivering an evidence-based technology to a large number of patients at low cost. Previous online applications have shown significant but variable improvements in sleep efficiency and a decrease in insomnia severity when compared with control groups. The best online methodology remains debated, and there are no such applications currently available within the UK National Health Service.
Effectiveness of internet-based CBT-I for the treatment of chronic subthreshold to moderate insomnia. [2023]To study the effectiveness of the first internet-based cognitive behavioral therapy for insomnia (CBT-i) in Thailand, using the Nitra application, for chronic subthreshold to moderate insomnia treatment.
CBT-I Coach: A Description and Clinician Perceptions of a Mobile App for Cognitive Behavioral Therapy for Insomnia. [2018]This paper describes CBT-I Coach, a patient-facing smartphone app designed to enhance cognitive behavioral therapy for insomnia (CBT-I). It presents findings of two surveys of U.S. Department of Veterans Affairs (VA) CBT-I trained clinicians regarding their perceptions of CBT-I Coach before it was released (n = 138) and use of it two years after it was released (n = 176).
Clinician Perceptions Related to the Use of the CBT-I Coach Mobile App. [2022]Objective: Clinicians' perceptions of CBT-I Coach, a patient-facing mobile app for cognitive-behavioral therapy for insomnia (CBT-I), are critical to its adoption and integration into practice. Diffusion of innovations theory emphasizes the influence of perceptions, including the relative advantage to current practice, the compatibility to clinicians' needs, the complexity, the innovation's trialability, and observability. This study intended to evaluate the use and perceptions of CBT-I Coach among Veterans Affairs (VA)-trained CBT-I clinicians. Participants and Methods: Clinicians (N = 108) were surveyed about their use, feedback, and perceptions of CBT-I Coach a year after the app became available. Results: Overall perceptions of CBT-I Coach were favorable. Fifty percent of clinicians reported using CBT-I Coach, with 98% intending to continue use. The app was perceived to increase sleep diary completion and homework compliance. Clinicians viewed the app as providing accessibility to helpful tools and improving patient engagement. Of those not using the app, 83% endorsed intention to use it. Reasons for nonuse were lack of patient access to smart phones, not being aware of the app, not having time to learn it, and inability to directly access app data. Those who reported using CBT-I Coach had more favorable perceptions across all constructs (p < .01 - p < .001), except relative advantage, compared to nonusers. Users perceived it as less complex and more compatible with their practice than nonusers. Conclusions: Continued efforts are needed to increase adoption and enhance use of CBT-I Coach, as well as study if reported benefits can be evidenced more directly.
Efficacy of a Smartphone-Based Virtual Companion to Treat Insomniac Complaints in the General Population: Sleep Diary Monitoring Versus an Internet Autonomous Intervention. [2023](1) Background: Insomnia is the most prevalent sleep disorder worldwide and cognitive behavioral therapy is the front-line treatment. Digital health technologies have a role to play in screening and delivering interventions remotely and without the need for human intervention. The KANOPEE app, which provides a screening and behavioral intervention for insomnia symptoms through an interaction with a virtual agent, showed encouraging results in previous studies during and after the COVID-19 lockdown, but has not yet been evaluated in a controlled study. This study aims at comparing the benefits of KANOPEE, a smartphone application dealing with insomnia complaints, with another application proposing an electronic sleep diary named “My Sleep Diary”. The acceptance and potential benefits of these digital solutions are tested in real-life settings (i.e., without soliciting human medical resources) and in the general population. (2) Methods: Subjects were included if they downloaded one of the apps between December 2020 and October 2021, and were of legal age. Both apps were available on downloading platforms in France. Primary outcome was Insomnia Severity Index (ISI), and secondary outcomes were total sleep time (TST), sleep efficiency (SE) and wake time after sleep onset (WASO). (3) Results: A total of 535 users completed the intervention with KANOPEE and 489 users completed My Sleep Diary, both for 17 days. KANOPEE users improved their ISI score significantly more than sleep diary users (interaction Time*Group: F(2,2002) = 17.3, p
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]Informal caregivers of people with dementia frequently experience chronic insomnia, contributing to stress and poor health outcomes. Rural caregivers are particularly vulnerable but have limited access to cognitive behavioral therapy for insomnia (CBT-I), a recommended frontline treatment for chronic insomnia. Web-based delivery promises to improve insomnia, particularly for rural caregivers who have limited access to traditional in-person treatments. Our team translated an efficacious 4-session standard CBT-I content protocol into digital format to create NiteCAPP.
Mobile App Use for Insomnia Self-Management: Pilot Findings on Sleep Outcomes in Veterans. [2020]Sleep disturbance is a major health concern among US veterans who have served since 2001 in a combat theater in Iraq or Afghanistan. We report subjective and objective sleep results from a pilot trial assessing self-management-guided use of a mobile app (CBT-i Coach, which is based on cognitive behavioral therapy for insomnia) as an intervention for insomnia in military veterans.
Developing and Testing a Web-Based Provider Training for Cognitive Behavioral Therapy of Insomnia. [2021]Chronic insomnia is a common and debilitating disease that increases risk for significant morbidity and workplace difficulties. Cognitive behavioral therapy for insomnia (CBT-I) is the first-line treatment, but there is a critical lack of behavioral health providers trained in CBT-I because, in part, of a bottleneck in training availability and costs. The current project developed and evaluated a web-based provider training course for CBT-I: CBTIweb.org.
Patient perspectives on facilitators and barriers to equitable engagement with digital CBT-I. [2023]Digital cognitive behavioral therapy for insomnia has significant advantages for dissemination and scalability vs. in-person cognitive behavioral therapy for insomnia and is, therefore, well-positioned to be the first-line intervention for insomnia. However, only about half of patients remit following digital cognitive behavioral therapy for insomnia. Evidence suggests that treatment engagement is a critical driver of digital cognitive behavioral therapy for insomnia effectiveness, and barriers to engagement disproportionately impact people from under-resourced communities. For digital cognitive behavioral therapy for insomnia to be effective and scalable, we need to identify facilitators and barriers to digital cognitive behavioral therapy for insomnia engagement.