Online vs Therapist-Directed Therapy for Insomnia with Sleep Apnea

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

384 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This two-site randomized clinical trial will investigate and compare three treatments for insomnia in patients who have been diagnosed with and treated for sleep apnea: online cognitive behavioral therapy (OCBT), therapist-directed cognitive behavioral therapy (TCBT), and standard clinical care. 384 patients will be recruited and will attend up to 15 visits over 10 months. Visits will include baseline assessment, treatment visits, and post-treatment follow-up visits. Visits will involve completion of questionnaires, meeting with therapists, and a physical exam.

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 online or therapist-directed therapy for insomnia with sleep apnea safe?

Research on online cognitive behavioral therapy for insomnia (OCBT-I) suggests it is generally safe for humans, as it has been studied in various forms and conditions without significant safety concerns. ^{1 2 3 4 5}

How does the treatment for insomnia with sleep apnea differ from other treatments?

This treatment is unique because it offers cognitive behavioral therapy for insomnia (CBT-I) through online platforms, making it more accessible to patients who may not have access to trained therapists. The online version (OCBT) can be a first step, with more intensive therapist-directed therapy (TCBT) reserved for those who need additional support, which is a novel approach for managing insomnia with sleep apnea. ^{1 3 4 6 7}

What data supports the effectiveness of the treatment Online Cognitive Behavioral Therapy (OCBT) and Therapist-directed Cognitive Behavioral Therapy (TCBT) for insomnia with sleep apnea?

Research shows that online cognitive behavioral therapy for insomnia (OCBT-i) can improve sleep efficiency and reduce insomnia severity, making it a promising option for treating sleep issues. Additionally, both online and face-to-face cognitive behavioral therapies have been found effective in improving sleep in people with insomnia. ^{3 4 7 8 9}

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.

I do not have an untreated major psychiatric disorder.

I have never been diagnosed with a psychotic or bipolar 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]

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]

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]

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]

Citations

1. England pubmed.ncbi.nlm.nih.gov

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

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

Guided Online or Face-to-Face Cognitive Behavioral Treatment for Insomnia: A Randomized Wait-List Controlled Trial. [2018]

3. 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]

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

Guided internet cognitive behavioral therapy for insomnia compared to a control treatment - A randomized trial. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Stepped care management of insomnia co-occurring with sleep apnea: the AIR study protocol. [2022]

7. 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]

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

Comparing internet-delivered cognitive therapy and behavior therapy with telephone support for insomnia disorder: a randomized controlled trial. [2021]

9. 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]