Internet-Based Cognitive Behavioral Therapy for COPD with Insomnia

No longer recruiting at 1 trial location

Overseen By Faith S Luyster, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Major depression, Suicidal risk, Substance abuse, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two online approaches to assist veterans with COPD (a lung disease that makes breathing difficult) who also suffer from insomnia. One group will receive internet-based therapy, similar to a digital version of talking with a therapist, while the other group will receive online education about insomnia. The goal is to determine which method most effectively improves sleep and daily functioning. Veterans with COPD who have internet access and ongoing insomnia affecting their daily life might be suitable candidates. As an unphased trial, this study provides veterans the chance to explore innovative online solutions for better sleep and improved daily life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this Internet-based behavioral treatment for insomnia is safe for Veterans with COPD and insomnia?

Research has shown that online cognitive behavioral therapy (CBT) for insomnia is generally easy for participants to manage. Studies have found that this treatment can improve sleep without causing serious side effects. Some participants have also reported improvements in other conditions, such as asthma, when using online CBT for insomnia.

Although specific information about side effects for this treatment is not available, online CBT has been used in other studies with positive results, suggesting it is likely safe for most people. Prospective trial participants should discuss any concerns with the study team or their doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the internet-based cognitive-behavioral therapy (CBT) for insomnia in COPD patients because it offers a unique, accessible alternative to traditional face-to-face therapy. Unlike standard treatments that often involve in-person sessions or medication, this online approach allows patients to receive help from the comfort of their own homes, making it particularly beneficial for those with mobility issues or living in remote areas. Additionally, the internet-based format can provide more flexible scheduling and consistent support, potentially leading to better adherence and outcomes. By addressing insomnia, a common issue in COPD patients, this treatment could significantly improve their overall quality of life.

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

Research has shown that online therapy for insomnia, known as internet-based cognitive behavioral therapy (ICBT-i), effectively improves sleep. Studies have found that this therapy enhances sleep quality and reduces insomnia symptoms over the long term. For individuals with chronic obstructive pulmonary disease (COPD), it has also alleviated tiredness and breathing difficulties. In this trial, participants will receive either an internet-based behavioral treatment for insomnia or online insomnia patient education. One study found that 75.4% of participants experienced improved sleep after using an online CBT program. This suggests that ICBT-i could benefit those with COPD and insomnia by enhancing sleep and overall health. ^{1 2 6 7 8}

Who Is on the Research Team?

Faith S Luyster, PhD

Principal Investigator

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Are You a Good Fit for This Trial?

This trial is for Veterans aged 40+ with COPD and moderate to severe insomnia, who have stable health conditions, access to the internet, and haven't been in pulmonary rehab recently. It's not for those with certain sleep disorders, very severe sleep apnea, extreme daytime sleepiness, restrictive lung diseases like asthma or plans to move soon.

Inclusion Criteria

I have been diagnosed with Insomnia Disorder.

I am eligible for a lung rehab program.

I have been diagnosed with COPD according to GOLD standards.

Exclusion Criteria

Plans to move during the following 9 months

Non-English speaking or sensory deficits

I have been in a lung rehab program in the last year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Internet-based behavioral treatment for insomnia or online insomnia patient education

8 weeks

Remote sessions

Follow-up

Participants are monitored for sleep and health-related functioning post-treatment

3 months

Remote assessments

Extended Follow-up

Participants' quality of life and disease impact are assessed

6 months

What Are the Treatments Tested in This Trial?

Interventions

• HBPR only
• Internet-based behavioral treatment for insomnia

Trial Overview The study tests if adding an Internet-based treatment for insomnia to home-based pulmonary rehabilitation (HBPR) helps improve sleep and health more than HBPR alone. Participants will be randomly placed into two groups: one receiving both treatments and the other only HBPR.

How Is the Trial Designed?

Group I: Online insomnia patient education Experimental Treatment 1 Intervention

Online insomnia patient education

Group II: Internet-based behavioral treatment for insomnia Experimental Treatment 1 Intervention

Internet version of cognitive-behavioral treatment for insomnia

HBPR only is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Cognitive Behavioral Therapy for Insomnia for:

• Insomnia
• Chronic Insomnia
• Comorbid Insomnia

Approved in European Union as Cognitive Behavioural Therapy for Insomnia for:

• Insomnia
• Chronic Insomnia
• Comorbid Insomnia

Approved in Canada as Internet-based Cognitive Behavioral Therapy for Insomnia for:

• Insomnia
• Chronic Insomnia
• Comorbid Insomnia

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

The HUS Helsinki University Hospital-iCBT for Insomnia program demonstrated significant effectiveness in treating insomnia, with 75.4% of the 2,464 patients completing the treatment and an average decline of 7.04 points on the Insomnia Severity Index (ISI).

A large proportion of participants (34.0%) achieved remission by the end of the treatment, and the effect size was substantial (Cohen's d = -1.449), indicating that this publicly funded, therapist-supported program is effective in routine care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of mobile-delivered, therapist-assisted cognitive behavioral therapy for insomnia in nationwide routine clinical care in Finland. Stenberg, JH., Ritola, V., Joffe, G., et al.[2023]

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]

A study involving 128 schoolteachers with insomnia showed that internet-based cognitive behavioral therapy for insomnia (iCBT-I) significantly improved health outcomes, with a 94% probability of being more effective than a wait list control group.

From a public health care perspective, iCBT-I was found to be more effective but also more expensive, with an incremental cost-effectiveness ratio of €650 per symptom-free individual, indicating it is a cost-effective intervention for treating insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guided Internet-Based Cognitive Behavioral Therapy for Insomnia: Health-Economic Evaluation From the Societal and Public Health Care Perspective Alongside a Randomized Controlled Trial. Buntrock, C., Lehr, D., Smit, F., et al.[2021]

Internet-based cognitive behavioral therapy for insomnia (iCBT-I) is perceived as effective and well-structured by psychiatric patients, leading to improvements in sleep quality and daily routines, despite challenges in maintaining motivation during difficult life events.

Participants reported that having contact with a therapist was crucial for motivation, suggesting that additional social support and adjustments could enhance the effectiveness of iCBT-I in secondary psychiatric care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Secondary psychiatric care patients' experiences of internet CBT for insomnia - a qualitative study. Nicolaisen Sidén, F., Spak, F.[2022]

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]

Cognitive Behavioral Therapy for Insomnia (CBT-I) is feasible and acceptable for individuals with Chronic Obstructive Pulmonary Disease (COPD), showing significant improvements in insomnia severity, sleep quality, and fatigue after a six-session intervention.

The study demonstrated that CBT-I led to notable enhancements in sleep-related outcomes, while a wellness education program also positively affected mood, indicating that both interventions can be beneficial for patients with COPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for insomnia comorbid with COPD is feasible with preliminary evidence of positive sleep and fatigue effects. Kapella, MC., Herdegen, JJ., Perlis, ML., et al.[2021]

Cognitive behavioural therapy for insomnia (CBT-I) delivered through a computerized format (CCBT-I) could improve access to treatment, as it addresses the shortage of trained providers, according to interviews with 23 health professionals and 28 patients.

To enhance the effectiveness and adherence to CCBT-I, the program must focus on building trust through accreditation and evidence of effectiveness, while also incorporating features like mobile access, self-assessment tools, and moderated peer support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating online communities and social networks with computerised treatment for insomnia: a qualitative study. Middlemass, J., Davy, Z., Cavanagh, K., 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04700098

Internet-based Cognitive-behavioral Treatment for ... Participants will undergo a sleep and health assessment that will be performed at baseline, post-treatment, and 3-months later. Participants will be randomly ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9713922/

Therapy for insomnia with chronic obstructive pulmonary ... CBT-I produced significant and sustained decreases in insomnia improved sleep and clinically important improvement in fatigue, and dyspnea.

3. withpower.com withpower.com/trial/phase-lung-diseases-obstructive-9-2021-d8962

Internet-Based Cognitive Behavioral Therapy for COPD ... The HUS Helsinki University Hospital-iCBT for Insomnia program demonstrated significant effectiveness in treating insomnia, with 75.4% of the 2,464 patients ...

4. jcsm.aasm.org jcsm.aasm.org/doi/abs/10.5664/jcsm.10210

Therapy for insomnia with chronic obstructive pulmonary ... Conclusions: CBT-I produced significant and sustained decreases in insomnia improved sleep and clinically important improvement in fatigue, and dyspnea. The ...

5. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0142258

Internet-Based Cognitive Behavioral Therapy for Insomnia ... The use of internet-based CBT for insomnia (ICBT-i) enables patients with insomnia to obtain treatment and communicate with the therapist at any time and place.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6433549/

Internet-based Cognitive-Behavioral Therapy for Insomnia ... Preliminary efficacy data suggest Internet-based CBT-I provided some relief from insomnia, and was associated with better asthma control. Qualitative interviews ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04700098/internet-based-cognitive-behavioral-treatment-for-insomnia-in-copd-patients-undergoing-pulmonary-rehabilitation

Internet-based Cognitive-behavioral Treatment for ... This study is a randomized controlled trial (RCT) to compare sleep and health-related functioning in Veterans with chronic obstructive pulmonary disease (COPD) ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4651423/

Internet-Based Cognitive Behavioral Therapy for Insomnia ... The use of internet-based CBT for insomnia (ICBT-i) enables patients with insomnia to obtain treatment and communicate with the therapist at any ...