Web-Based Cognitive Behavioral Therapy for Caregiver Insomnia

(NiteCAPP Trial)

Overseen By Riley Stephens

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of South Florida

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)

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

Compensation: Varies

Number of Visits: 4

Duration: 6 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an online therapy program designed to help caregivers of people with dementia who struggle with insomnia. The therapy, Cognitive Behavioral Therapy for Insomnia (CBT-I), is a well-known method for improving sleep and mood. Researchers aim to determine if a web-based format can enhance accessibility and effectiveness for caregivers. Caregivers experiencing insomnia symptoms, such as difficulty falling or staying asleep, and who live with someone with dementia, may be suitable for this trial. The study will focus on changes in sleep quality, mood, and daily functioning. As an unphased trial, it offers caregivers access to innovative therapy that could enhance their well-being.

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 prior data suggests that this web-based therapy is safe for caregivers?

Research has shown that online cognitive behavioral therapy for insomnia (CBT-I) is generally safe, as it doesn't involve surgery or medication. Although specific safety data for caregivers using this online version is lacking, CBT-I is recognized for its safety.

CBT-I helps modify sleep habits and thoughts that may contribute to sleep problems. It avoids the risks associated with some medications. Most individuals tolerate it well, with few reports of negative effects. This makes it a suitable option for those seeking to improve their sleep without medication side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Web-based Cognitive Behavioral Therapy for Insomnia (CBT-I) because it offers a convenient, accessible alternative to traditional in-person therapy sessions. Unlike standard treatments, which often involve face-to-face meetings with a therapist, this online approach allows caregivers struggling with insomnia to access therapy from the comfort of their own homes at any time. This flexibility can lead to better adherence and potentially faster relief from symptoms, making it an appealing option for those with busy schedules or limited access to healthcare facilities.

What evidence suggests that Web-based CBT-I is effective for caregiver insomnia?

Research has shown that Cognitive Behavioral Therapy for Insomnia (CBT-I) effectively helps adults with sleep problems. In this trial, participants will use the online version, NiteCAPP, which studies have found can significantly reduce insomnia symptoms for caregivers, even when accessed online. Early results suggest that online CBT-I improves sleep and mood with noticeable positive effects. This option suits caregivers who lack time for in-person therapy, especially those in rural areas or with limited access to traditional treatments. Overall, online CBT-I offers a flexible and accessible way for caregivers to manage insomnia. ^{1 3 6 7 8}

Who Is on the Research Team?

Christina McCrae, PhD

Principal Investigator

University of Missouri-Columbia

Are You a Good Fit for This Trial?

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

Exclusion Criteria

Other major psychopathology except depression or anxiety

Severe untreated psychiatric comorbidity

I am on medication that affects my sleep.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Web-based Cognitive Behavior Therapy for Insomnia (CBT-I)

Trial Overview 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.

How Is the Trial Designed?

Group I: NiteCAPP: Online Cognitive Behavioral Therapy for Insomnia Experimental Treatment 1 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

Who Is Running the Clinical Trial?

University of South Florida

Lead Sponsor

Trials

433

Recruited

198,000+

University of Missouri-Columbia

Lead Sponsor

Trials

387

Recruited

629,000+

Published Research Related to This Trial

The study aims to evaluate the effectiveness of the internet-delivered cognitive behavioral therapy program, SHUTi, for insomnia among 100 higher-intensity caregivers, focusing on how their caregiving context affects their engagement with the program.

By understanding the barriers and motivations for caregivers' engagement with SHUTi, the research seeks to tailor the intervention to better meet the unique needs of caregivers, potentially improving access to effective insomnia treatment for this underserved population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-Group Trial of an Internet-Delivered Insomnia Intervention Among Higher-Intensity Family Caregivers: Rationale and Protocol for a Mixed Methods Study. Shaffer, KM., Ritterband, LM., You, W., et al.[2022]

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]

A significant percentage (40-76%) of caregivers for cancer patients experience sleep disturbances, which can negatively impact their mental and physical health due to the unique stressors of caregiving.

Cognitive-behavioral therapy for insomnia (CBT-I) can be tailored to address the specific needs of cancer caregivers, and developing effective treatments could improve their quality of life and health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insomnia among Cancer Caregivers: A Proposal for Tailored Cognitive Behavioral Therapy. Shaffer, KM., Garland, SN., Mao, JJ., et al.[2023]

The study explored the acceptability and feasibility of using computerized cognitive behavioral therapy for insomnia (CCBT-I) as an adjunctive treatment for depressed patients in a psychiatric clinic, highlighting that clinician support and program coordination are crucial for patient engagement and persistence.

Participants identified the sleep restriction component of the CCBT-I program as a significant challenge, indicating that clinicians should be aware of this when integrating the program into treatment to optimize its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Commencing and Persisting With a Web-Based Cognitive Behavioral Intervention for Insomnia: A Qualitative Study of Treatment Completers. Chan, C., West, S., Glozier, N.[2018]

In a study involving 57 adolescents undergoing guided Internet cognitive behavioral therapy for insomnia (CBTI), the factor of 'Sleep expertise' in therapeutic feedback was found to significantly contribute to improvements in insomnia symptoms, while other feedback types, like encouragement, were less effective or even counterproductive.

The study suggests that focusing on providing knowledge about sleep is crucial for enhancing treatment outcomes, highlighting the need for further research to identify effective therapeutic factors in Internet-based therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of online therapeutic feedback on outcome measures in Internet-CBTI for adolescents with insomnia. de Bruin, EJ., Meijer, AM.[2018]

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]

Both internet-based cognitive behavioral treatments for insomnia (MCT and SRT) were significantly more effective than care as usual, with MCT showing a large effect size for insomnia severity (Cohen's d = -1.15) after eight weeks.

Participants in the multi-component treatment (MCT) reported higher satisfaction compared to those in the sleep restriction treatment (SRT), although both treatments had similar efficacy outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial comparing guided internet-based multi-component treatment and internet-based guided sleep restriction treatment to care as usual in insomnia. Krieger, T., Urech, A., Duss, SB., et al.[2020]

Internet-based cognitive-behavioral therapy for insomnia (ICBT-i) significantly improves sleep outcomes in adults, with participants experiencing a decrease in sleep onset latency by 18.41 minutes and an increase in total sleep time by 22.30 minutes based on a meta-analysis of 15 studies involving 1013 participants.

ICBT-i also enhances sleep efficiency by 9.58% and reduces wake after sleep onset by 22.31 minutes, demonstrating its effectiveness as a treatment for insomnia that warrants further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-based cognitive-behavioural therapy for insomnia (ICBT-i): a meta-analysis of randomised controlled trials. Ye, YY., Chen, NK., Chen, J., et al.[2019]

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]

The study is evaluating NiteCAPP CARES, a digital cognitive behavioral therapy for insomnia (CBT-I) designed for rural caregivers, aiming to improve sleep and reduce stress-related health issues in caregivers of individuals with dementia.

With 100 caregiver-dyad participants, the trial will assess the effectiveness of NiteCAPP CARES over 4 weeks and follow up for 12 months, measuring various health and cognitive outcomes to understand how the intervention impacts caregiver well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. McCrae, CS., Curtis, AF., Cottle, A., 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]

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

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 ...

3. 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).

4. 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.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165178123000197

A two-arm, multi-center, randomized controlled trial This one-week internet-delivered CBT-I program is an effective tool to prevent the chronicity of acute insomnia.

6. withpower.com withpower.com/trial/phase-dementia-2022-2438a

Web-Based Cognitive Behavioral Therapy for Caregiver ... 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- ...

7. mental.jmir.org mental.jmir.org/2024/1/e51716

Assessing the Short-Term Efficacy of Digital Cognitive ... This study examines whether adding chatbot-based and human coaching would improve the treatment efficacy of, and adherence to, dCBTi.

8. researchgate.net researchgate.net/publication/372120520_Development_and_Initial_Evaluation_of_Web-based_Cognitive_Behavioral_Therapy_for_Insomnia_NiteCAPPSM_in_Rural_Family_Dementia_Caregivers_A_Mixed-Methods_Study_Preprint

(PDF) Development and Initial Evaluation of Web-based ... PDF | Background Informal caregivers of people with dementia frequently experience chronic insomnia, contributing to stress and poor health outcomes.