Internet-Based Cognitive Behavioral Therapy for COPD with Insomnia

Recruiting at 1 trial location

Overseen by Faith S Luyster, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: VA Office of Research and Development

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study is a randomized controlled trial (RCT) to compare sleep and health-related functioning in Veterans with chronic obstructive pulmonary disease (COPD) and insomnia receiving an Internet-based behavioral treatment for insomnia versus online insomnia patient education. Participants will undergo a sleep and health assessment that will be performed at baseline, post-treatment, and 3-months later. Participants will be randomly assigned to either Internet-based behavioral treatment for insomnia or online insomnia patient education.

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 data supports the effectiveness of the treatment Internet-Based Cognitive Behavioral Therapy for COPD with Insomnia?

Research shows that internet-based cognitive behavioral therapy for insomnia (iCBT-I) is effective and can be as beneficial as face-to-face therapy. It has been shown to improve sleep in various settings and could help people with insomnia, even when they have other health issues. ^{1 2 3 4 5}

Is Internet-Based Cognitive Behavioral Therapy for Insomnia safe for humans?

The research on Internet-Based Cognitive Behavioral Therapy for Insomnia (iCBT-I) does not specifically mention safety concerns, suggesting it is generally considered safe for humans. ^{1 2 4 6 7}

How is Internet-based CBT-I different from other treatments for COPD with insomnia?

Internet-based CBT-I is unique because it provides cognitive behavioral therapy for insomnia online, making it more accessible to people who may not have access to trained therapists. It is effective for improving sleep in people with COPD, a condition where traditional insomnia treatments may not work as well due to disease-related sleep issues. ^{1 2 3 5 8}

Research Team

Faith S Luyster, PhD

Principal Investigator

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• HBPR only (Behavioral)
• Internet-based behavioral treatment for insomnia (Behavioral Intervention)

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.

Participant Groups

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 Canada for the following indications:

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+

Dr. Grant Huang

VA Office of Research and Development

Acting Chief Research and Development Officer

PhD in Medical Psychology and Master of Public Health from the Uniformed Services University of Health Sciences

Dr. Erica M. Scavella

VA Office of Research and Development

Chief Medical Officer since 2022

MD from University of Massachusetts School of Medicine

Findings from Research

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]

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) 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]

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]

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]

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]

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]

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]

References

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

Effectiveness of mobile-delivered, therapist-assisted cognitive behavioral therapy for insomnia in nationwide routine clinical care in Finland. [2023]

2. 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]

3. England pubmed.ncbi.nlm.nih.gov

Secondary psychiatric care patients' experiences of internet CBT for insomnia - a qualitative study. [2022]

4. England pubmed.ncbi.nlm.nih.gov

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

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

Integrating online communities and social networks with computerised treatment for insomnia: a qualitative study. [2023]

6. Canada 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. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of internet-based CBT-I for the treatment of chronic subthreshold to moderate insomnia. [2023]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for insomnia comorbid with COPD is feasible with preliminary evidence of positive sleep and fatigue effects. [2021]