Telehealth vs Web-Based CBT for Insomnia

(CLEAR Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: University of Kansas Medical Center

Must not be taking: Benzodiazepines, Non-benzodiazepines, Melatonin

Disqualifiers: Sleep apnea, Severe depression, Severe anxiety, Alcohol abuse, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The objective of this RCT is to assess the efficacy of one-on-one telehealth CBT-I (tCBT-I) compared to web-based CBT-I (wCBT-I) and treatment as usual (TAU) to improve sleep outcomes (Aim 1), fatigue and quality of life (Aim 2), and promote neuroprotection (Exploratory Aim 3), and to explore the characteristics of participants that predict improvement in sleep outcomes (Exploratory Aim 4). Reassessment of outcomes will be completed after the 6-week intervention and 6 months following completion of interventions.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are taking benzodiazepines, non-benzodiazepines, or melatonin supplements for insomnia, you must have been on a stable dose for at least 3 months.

What data supports the effectiveness of the treatment Telehealth cognitive behavioral therapy for insomnia (tCBT-I)?

Research shows that telehealth and internet-based cognitive behavioral therapy for insomnia (CBT-I) can significantly improve sleep efficiency and reduce insomnia severity. Studies and meta-analyses indicate that tele-CBT-I is effective compared to face-to-face CBT-I and placebo, making it a promising option for those who cannot access traditional therapy. ^{1 2 3 4 5}

Is digital cognitive behavioral therapy for insomnia (dCBT-I) safe for humans?

Digital cognitive behavioral therapy for insomnia (dCBT-I) is generally considered safe for humans. It is a non-drug therapy that has been shown to improve sleep and reduce insomnia severity without significant safety concerns. ^{1 6 7 8 9}

How does the treatment Telehealth vs Web-Based CBT for Insomnia differ from other treatments for insomnia?

This treatment is unique because it uses telehealth and web-based platforms to deliver cognitive behavioral therapy for insomnia (CBT-I), making it more accessible to people who may not have easy access to in-person therapy. It allows for both therapist-assisted and self-directed options, which can be more flexible and cost-effective compared to traditional face-to-face therapy. ^{1 2 3 10 11}

Research Team

Eligibility Criteria

This trial is for adults aged 18-65 with relapsing-remitting or secondary progressive MS, experiencing sleep issues at least three nights a week for the past three months. Participants should have mild-to-moderate disability, be English-speaking, and have internet access. Those with severe disabilities or other sleep disorders are excluded.

Inclusion Criteria

My disability level is mild to moderate.

I am between 18 and 65 years old.

My neurologist confirmed I have relapsing-remitting or secondary progressive MS.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either telehealth-delivered CBT-I or web-based CBT-I for 6 weeks

6 weeks

1 visit per week (telehealth or web-based)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Reassessment at 6 months

Treatment Details

Interventions

• Telehealth cognitive behavioral therapy for insomnia (tCBT-I) (Behavioral Intervention)
• Treatment as usual (TAU) (Behavioral Intervention)
• Web-based cognitive behavioral therapy for insomnia (wCBT-I) (Behavioral Intervention)

Trial Overview The study compares one-on-one telehealth CBT-I (tCBT-I) and web-based CBT-I (wCBT-I) against usual treatments to see which improves sleep, reduces fatigue, enhances quality of life, and potentially protects the brain in people with MS.

Participant Groups

Group I: Web-based cognitive behavioral therapy for insomnia (wCBT-I) Experimental Treatment 1 Intervention

The Go!ToSleep online program is a 6-week interactive, web-based program that delivers typical CBT-I treatment techniques of stimulus control, sleep restriction, behavioral modifications, relaxation techniques and cognitive restructuring with daily lessons (41 lessons in total)

Group II: Treatment as usual (TAU) Experimental Treatment 1 Intervention

The treatment as usual comparison group will be encouraged to continue with their usual care recommended by their physician and their usual activities and sleep habits during the period between baseline and 6-month reassessment.

Group III: Telehealth cognitive behavioral therapy for insomnia (tCBT-I) Experimental Treatment 1 Intervention

1x/week, 6-week 45-60 min one-one-one manualized program via video conferencing (HIPAA-compliant Zoom) with a trained research assistant that includes time in bed restriction, stimulus control, relaxation strategies, cognitive restructuring, and sleep health promotion education.

Telehealth cognitive behavioral therapy for insomnia (tCBT-I) is already approved in Canada for the following indications:

Approved in Canada as Cognitive Behavioral Therapy for Insomnia for:

• Insomnia
• Sleep Disturbances
• Fatigue

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Dr. Steve Stites

University of Kansas Medical Center

Chief Executive Officer

MD from University of Kansas School of Medicine

Dr. Matthias Salathe

University of Kansas Medical Center

Chief Medical Officer

MD from University of Kansas School of Medicine

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]

Cognitive behavioral therapy for insomnia (CBT-i) is the recommended first-line treatment for insomnia, and telemedicine options for CBT-i enhance access for patients, especially those in remote areas.

Research, including multiple studies and meta-analyses, shows that tele-CBT-i is effective, performing comparably to traditional face-to-face CBT-i and better than placebo treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemedicine and the Management of Insomnia. Hsieh, C., Rezayat, T., Zeidler, MR.[2020]

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]

Cognitive Behavioral Therapy for Insomnia (CBTI) is the preferred treatment for chronic insomnia, but many patients opt for medication due to cost and availability issues.

Internet-based CBTI (I-CBTI) is well-accepted by patients and significantly improves insomnia symptoms, suggesting it could be a valuable alternative for those unable to access traditional CBTI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-Delivered Cognitive Behavioral Therapy for Insomnia: Tailoring Cognitive Behavioral Therapy for Insomnia for Patients with Chronic Insomnia. van der Zweerde, T., Lancee, J., Ida Luik, A., et al.[2020]

Cognitive behavioral therapy for insomnia (CBTI) is the recommended first-line treatment for insomnia, but its high cost and limited availability of trained providers hinder access, especially for vulnerable groups like military personnel and the elderly.

Digital CBTI (dCBTI) is emerging as a promising and scalable alternative that could improve access to effective insomnia treatment, particularly for those who face barriers to traditional CBTI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insomnia overview: epidemiology, pathophysiology, diagnosis and monitoring, and nonpharmacologic therapy. Dopheide, JA.[2021]

The French-speaking automated Internet-delivered CBT-I (eCBT-I) program significantly reduced insomnia severity compared to minimal psychoeducation therapy (mPT) in a study of 46 adults over 12 weeks.

Participants in the eCBT-I group also experienced improvements in depressive symptoms, fatigue, anxiety, and quality of life, with a high percentage reducing or stopping their use of CNS-active medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

French Language Online Cognitive Behavioral Therapy for Insomnia Disorder: A Randomized Controlled Trial. Lopez, R., Evangelista, E., Barateau, L., et al.[2023]

A pilot study involving 20 individuals with opioid use disorder showed that adding a web-based cognitive-behavioral therapy (CBT4CBT) program to standard buprenorphine treatment significantly improved retention and reduced drug use, with 91% of participants in the CBT group testing negative for opioids compared to 64% in the standard treatment group.

Participants using CBT4CBT completed an average of 82.6 days of treatment, indicating higher engagement compared to 68.6 days for those receiving only standard buprenorphine, suggesting that web-based interventions can enhance treatment adherence and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized pilot trial of Web-based cognitive-behavioral therapy adapted for use in office-based buprenorphine maintenance. Shi, JM., Henry, SP., Dwy, SL., et al.[2022]

Computerized cognitive behavioral therapy for insomnia (CCBT-I) has been shown to significantly improve various sleep-related outcomes, such as sleep quality and sleep efficiency, based on a meta-analysis of 6 randomized controlled trials involving 533 papers.

With a high treatment adherence rate of 78% and a moderate effect size, CCBT-I is considered a viable low-intensity self-help therapy for insomnia, making it a useful option in stepped care models for treating sleep disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerised cognitive behavioural therapy for insomnia: a systematic review and meta-analysis. Cheng, SK., Dizon, J.[2022]

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]

The Tele-Insomnia program successfully delivered group cognitive behavioral treatment for insomnia (CBT-I) via telehealth to veterans, resulting in significant improvements in insomnia severity and sleep quality, as measured by the Insomnia Severity Index and sleep diaries.

The program demonstrated excellent video quality and minimal connectivity issues, indicating that telehealth is a viable and scalable option for providing effective insomnia treatment to increase access for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Group Cognitive-Behavioral Treatment of Insomnia Delivered by Clinical Video Telehealth. Gehrman, P., Shah, MT., Miles, A., et al.[2018]

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

Telemedicine and the Management of Insomnia. [2020]

3. 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]

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

Internet-Delivered Cognitive Behavioral Therapy for Insomnia: Tailoring Cognitive Behavioral Therapy for Insomnia for Patients with Chronic Insomnia. [2020]

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

Insomnia overview: epidemiology, pathophysiology, diagnosis and monitoring, and nonpharmacologic therapy. [2021]

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

French Language Online Cognitive Behavioral Therapy for Insomnia Disorder: A Randomized Controlled Trial. [2023]

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

Randomized pilot trial of Web-based cognitive-behavioral therapy adapted for use in office-based buprenorphine maintenance. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Computerised cognitive behavioural therapy for insomnia: a systematic review and meta-analysis. [2022]

10. 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]

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

Feasibility of Group Cognitive-Behavioral Treatment of Insomnia Delivered by Clinical Video Telehealth. [2018]