Online vs Therapist-Directed Therapy for Insomnia with Sleep Apnea

Not currently recruiting at 1 trial location

Overseen By Rachel Johnson, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: National Jewish Health

Must be taking: PAP therapy

Must not be taking: Stimulants

Disqualifiers: Psychiatric disorders, Bipolar, Substance abuse, others

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

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find the best way to treat insomnia in individuals with sleep apnea. It will compare online cognitive behavioral therapy (OCBT), therapist-led cognitive behavioral therapy (TCBT), and standard care. Participants will attend up to 15 visits over 10 months for assessments, therapy sessions, and follow-ups. The trial seeks individuals who have sleep apnea, use a CPAP machine, and still struggle with falling or staying asleep despite having the opportunity to get enough sleep.

As an unphased trial, this study offers a unique opportunity to explore innovative treatments for improved sleep health.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using medications known to cause insomnia, like stimulants.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both online and therapist-led cognitive behavioral therapy (CBT) for insomnia are safe and effective for people with sleep apnea. Studies have found that online CBT can improve sleep and reduce sleep apnea symptoms. No serious side effects have been reported, indicating it is well-tolerated.

Therapist-led CBT is also safe for those with both insomnia and sleep apnea. This method is effective when provided by trained professionals, and research has not reported any major negative effects.

Both treatments aim to improve sleep without medication, often resulting in fewer side effects. Overall, evidence supports the safety of both online and therapist-led CBT for treating insomnia in people with sleep apnea. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they offer a fresh approach to managing insomnia in people with sleep apnea. Unlike traditional treatments that might involve medication or standard sleep hygiene practices, these new methods leverage Cognitive Behavioral Therapy (CBT) in two distinct formats: online (OCBT) and therapist-directed (TCBT). The online method allows for more flexibility and accessibility, giving patients the chance to engage with therapy at their own pace and convenience. On the other hand, therapist-directed therapy provides personalized guidance, potentially leading to more tailored and effective treatment outcomes. This trial aims to discover which method might be more effective or suitable for different individuals, offering hope for more customized insomnia treatments.

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

Research has shown that both online and therapist-led cognitive behavioral therapy (CBT) effectively treat insomnia, even when combined with sleep apnea. In this trial, participants in the intervention arm will initially receive Online Cognitive Behavioral Therapy (OCBT). Studies have found that digital CBT can greatly improve sleep quality and lessen insomnia symptoms. It also helps people with depression. Participants who do not achieve remission with OCBT may be randomized to receive either extended OCBT or Therapist-directed Cognitive Behavioral Therapy (TCBT). Therapist-led CBT is well-supported and now considered the best initial treatment for insomnia. Evidence suggests that CBT, whether online or with a therapist, can also reduce the severity of sleep apnea along with insomnia. Both methods have shown promising results in improving sleep for people with these conditions. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 21 with sleep apnea and mild insomnia, using PAP therapy for at least a month. They must have trouble sleeping despite having the chance to sleep well and feel daytime effects from poor sleep. Excluded are those with certain other sleep disorders, regular marijuana use after 4 PM, untreated major depression, recent substance abuse, or severe illnesses like cancer.

Inclusion Criteria

I am older than 21 years.

You take longer than 30 minutes to fall asleep or you wake up and have trouble falling back asleep at least 3 nights a week for 2 weeks.

I have been diagnosed with sleep apnea and my AHI score is above 5.

Exclusion Criteria

You are at high risk of harming yourself.

You drink more than two alcoholic beverages every day.

I do not have an untreated major psychiatric disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants complete baseline assessments including questionnaires and physical exams

1 week

1 visit (in-person)

First-stage Treatment

Participants receive Online Cognitive Behavioral Therapy (OCBT) or usual care with PAP therapy and sleep hygiene education

8 weeks

Multiple visits (in-person and virtual)

Second-stage Treatment

Participants not meeting remission criteria are re-randomized to extended OCBT or Therapist-directed CBT (TCBT)

8 weeks

Multiple visits (in-person and virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Online Cognitive Behavioral Therapy (OCBT)
• Therapist-directed Cognitive Behavioral Therapy (TCBT)

Trial Overview

The study compares three treatments: online cognitive behavioral therapy (OCBT), therapist-directed CBT (TCBT), and standard care for people with insomnia and treated sleep apnea. Participants will attend up to 15 visits including assessments, therapy sessions, and follow-ups over 10 months.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 2 Interventions

In addition to standard care procedures, participants randomized to the intervention arm will receive up to two sequential treatments. First, participants will receive Online Cognitive Behavioral Therapy (OCBT). Those who meet criteria for remission after this first treatment will continue through follow-up without further treatment. Those who do not will be randomized again to either extended OCBT, or Therapist-directed Cognitive Behavioral Therapy (TCBT).

Group II: Standard Care Active Control 1 Intervention

Participants randomized to standard care will receive normal follow-up care with their health care provider. This will include routine assessment and adjustment of PAP therapy, and instruction in proper sleep hygiene.

Who Is Running the Clinical Trial?

National Jewish Health

Lead Sponsor

Trials

145

Recruited

318,000+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

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]

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]

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]

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