Web-Based Cognitive Behavioral Therapy for Caregiver Insomnia
(NiteCAPP Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of South Florida
Must not be taking: Psychotropics, Beta-blockers
Disqualifiers: Cognitive impairment, Sleep apnea, Bipolar, others
No Placebo Group
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?This trial aims to test an online therapy called NiteCAPP, which helps family caregivers of dementia patients manage insomnia. The therapy teaches better sleep habits and coping strategies, making it easier for caregivers to use at home. The goal is to improve sleep, mood, and overall health for these caregivers.
Will I have to stop taking my current medications?
The trial requires that participants either not be on prescribed or over-the-counter sleep medications or have been stabilized on them for at least 6 weeks. Additionally, participants cannot be on medications that alter sleep, such as certain psychotropic drugs or beta-blockers.
What data supports the effectiveness of the treatment Web-based Cognitive Behavioral Therapy for Insomnia (CBT-I)?
Research shows that online cognitive behavioral therapy for insomnia (CBT-I) can improve sleep efficiency and reduce insomnia severity. Studies have found that internet-based CBT-I is effective for treating chronic insomnia, and it is considered a promising approach for delivering therapy to many people at a low cost.
12345Is web-based cognitive behavioral therapy for insomnia safe for humans?
The research does not provide specific safety data for web-based cognitive behavioral therapy for insomnia, but it is generally considered safe as it is a non-invasive, psychological treatment.
12367How is the web-based CBT-I treatment unique for caregiver insomnia?
This web-based CBT-I treatment is unique because it is specifically tailored for caregivers, addressing their unique stressors and responsibilities, and is delivered online to improve accessibility, especially for those in rural areas who may not have access to traditional in-person therapy.
2891011Eligibility Criteria
This trial is for dementia caregivers over 18, living with the person they care for. They must have insomnia lasting 6+ months, affecting their daily life, and understand English. Participants should not be on new sleep meds or have unstable medication use in the past 6 weeks.Inclusion Criteria
I haven't taken sleep meds recently or have been stable on them for over 6 weeks.
I have been diagnosed with insomnia.
Willing to be randomized
+8 more
Exclusion Criteria
Other major psychopathology except depression or anxiety
Severe untreated psychiatric comorbidity
I am on medication that affects my sleep.
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive a web-based Cognitive Behavioral Therapy for Insomnia (CBT-I) over 4 sessions
6 weeks
4 sessions (online)
Follow-up
Participants are monitored for changes in sleep, mood, and cognitive functioning after treatment
4 weeks
Participant Groups
The study tests a web-based Cognitive Behavioral Therapy program (WebCBT-I) called NiteCAPP designed to help dementia caregivers manage insomnia. It aims to improve sleep quality and reduce related health issues like fatigue and mood disorders.
1Treatment groups
Experimental Treatment
Group I: NiteCAPP: Online Cognitive Behavioral Therapy for InsomniaExperimental Treatment1 Intervention
This is a pilot trial with one treatment condition (CBT-I).
Web-based Cognitive Behavior Therapy for Insomnia (CBT-I) is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as CBT-I for:
- Insomnia in adults
- Insomnia in dementia caregivers
🇪🇺 Approved in European Union as CBT-I for:
- Insomnia in adults
- Insomnia in dementia caregivers
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MissouriColumbia, MO
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Who Is Running the Clinical Trial?
University of South FloridaLead Sponsor
University of Missouri-ColumbiaLead Sponsor
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.
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.
A randomized controlled trial comparing guided internet-based multi-component treatment and internet-based guided sleep restriction treatment to care as usual in insomnia. [2020]Internet-based cognitive behavioral treatment (iCBT-I) for insomnia comprising different sleep-related cognitive and behavioral interventional components has shown some promise. However, it is not known which components are necessary for a good treatment outcome.
Internet-based cognitive-behavioural therapy for insomnia (ICBT-i): a meta-analysis of randomised controlled trials. [2019]To evaluate the effectiveness of internet-based cognitive-behavioural therapy for insomnia (ICBT-i) in adults.
Commencing and Persisting With a Web-Based Cognitive Behavioral Intervention for Insomnia: A Qualitative Study of Treatment Completers. [2018]Computerized cognitive behavioral therapy for insomnia (CCBT-I) has a growing evidence base as a stand-alone intervention, but it is less clear what factors may limit its acceptability and feasibility when combined with clinical care.
The impact of online therapeutic feedback on outcome measures in Internet-CBTI for adolescents with insomnia. [2018]Guided Internet cognitive behavioral therapy for insomnia (CBTI) offers an effective treatment for adolescents, but little is known about the active ingredients of therapeutic feedback on outcomes.
Single-Group Trial of an Internet-Delivered Insomnia Intervention Among Higher-Intensity Family Caregivers: Rationale and Protocol for a Mixed Methods Study. [2022]Family caregivers are more likely to experience insomnia relative to noncaregivers but have significant barriers to accessing gold standard cognitive behavioral therapy for insomnia treatment. Delivering interventions to caregivers through the internet may help increase access to care, particularly among higher-intensity caregivers who provide assistance with multiple care tasks over many hours per week. Although there are existing internet interventions that have been thoroughly studied and demonstrated as effective in the general population, the extent to which these interventions may be effective for caregivers without tailoring to address this population's unique psychosocial needs has not been studied.
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.
Impact of Web-Based Cognitive Behavioral Therapy for Insomnia on Stress, Health, Mood, Cognitive, Inflammatory, and Neurodegenerative Outcomes in Rural Dementia Caregivers: Protocol for the NiteCAPP CARES and NiteCAPP SHARES Randomized Controlled Trial. [2023]Chronic insomnia affects up to 63% of family dementia caregivers. Research suggests that chronic insomnia prompts changes in central stress processing that have downstream negative effects on health and mood, as well as on cognitive, inflammatory, and neurodegenerative functioning. We hypothesize that cognitive behavioral therapy for insomnia (CBT-I) will reverse those downstream effects by improving insomnia and restoring healthy central stress processing. Rural caregivers are particularly vulnerable, but they have limited access to CBT-I; therefore, we developed an accessible digital version using community input (NiteCAPP CARES).
Insomnia among Cancer Caregivers: A Proposal for Tailored Cognitive Behavioral Therapy. [2023]Caregivers are relatives, friends, or partners who have a significant relationship with and provide assistance (i.e., physical, emotional) to a patient with often life-threatening, serious illnesses. Between 40 and 76 percent of caregivers for people with cancer experience sleep disturbance. This is thought to be due, in part, to the unique responsibilities, stressors, and compensatory behaviors endemic to caregiving that serve as precipitating and perpetuating factors of insomnia. Sleep disturbances are associated with significant alterations in one's mental and physical health. Once chronic, insomnia does not remit naturally. Cognitive-behavioral therapy for insomnia (CBT-I) is well-suited to address the multifaceted contributing factors unique to caregivers' sleep disturbance, yet only one intervention has tested a CBT-I informed intervention among cancer caregivers. Toward the goal of developing effective, tailored treatments for insomnia in caregivers, we address the distinct presentation of insomnia among cancer caregivers and describe key modifications to standard CBT-I that address these specific needs and enhance sensitivity and feasibility, modeled in a demonstrative case vignette. Future research must seek to provide a wide range of effective treatment options for this population, including internet-based, dyadic, and alternative integrative medicine treatments. Applicability of key modifications for caregivers of patients with other chronic illnesses is discussed. Establishing empirically-supported interventions for insomnia among cancer caregivers has the potential to enhance their quality of life and care provided, lead to improved bereavement outcomes, and attenuate the notable mental and physical health disparities present in this vulnerable population.