Web-Based Cognitive Behavioral Therapy for Caregiver Insomnia

(NiteCAPP Trial)

Overseen by Christina McCrae, PhD

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. ^{1 2 3 4 5}

Is 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. ^{1 2 3 6 7}

How 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. ^{2 8 9 10 11}

Research Team

Christina McCrae, PhD

Principal Investigator

University of Missouri-Columbia

Eligibility 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

Exclusion Criteria

Other major psychopathology except depression or anxiety

Severe untreated psychiatric comorbidity

I am on medication that affects my sleep.

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

Treatment Details

Interventions

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

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.

Participant Groups

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

This is a pilot trial with one treatment condition (CBT-I).

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+

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]

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 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]

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]

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]

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]

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. England pubmed.ncbi.nlm.nih.gov

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

4. Netherlands 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. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Internet-based cognitive-behavioural therapy for insomnia (ICBT-i): a meta-analysis of randomised controlled trials. [2019]

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

Commencing and Persisting With a Web-Based Cognitive Behavioral Intervention for Insomnia: A Qualitative Study of Treatment Completers. [2018]

7. Netherlands pubmed.ncbi.nlm.nih.gov

The impact of online therapeutic feedback on outcome measures in Internet-CBTI for adolescents with insomnia. [2018]

8. Canada 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. [2022]

9. 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]

10. Canada 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. [2023]

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

Insomnia among Cancer Caregivers: A Proposal for Tailored Cognitive Behavioral Therapy. [2023]