Digital Cognitive Behavioral Therapy with Coaching for Insomnia

(DigIT Trial)

Recruiting at 4 trial locations

Overseen By Eric Hermes, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Psychotic, Bipolar, Dementia, Epilepsy, others

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

Compensation: Varies

Number of Visits: 3

244 Participants Needed

Trial Summary

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 would be best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the treatment Virtual Coaching for insomnia?

Research shows that digital cognitive behavioral therapy (CBT) for insomnia, which includes online and app-based methods, can significantly improve sleep efficiency and reduce insomnia severity. These digital therapies have been effective in both short-term and long-term improvements in sleep and overall well-being. ^{1 2 3 4 5}

Is digital cognitive behavioral therapy with coaching for insomnia safe for humans?

Digital cognitive behavioral therapy (CBT) for insomnia is considered safe for patients, as it avoids the side effects associated with medication and shows sustainable improvement in sleep issues. ^{1 2 6 7 8}

How is Virtual Coaching for insomnia different from other treatments?

Virtual Coaching for insomnia is unique because it combines digital cognitive behavioral therapy (CBT) with personalized coaching, making it more interactive and tailored to individual needs compared to standard digital CBT, which is often fully automated. This approach can enhance engagement and effectiveness by providing real-time support and guidance. ^{4 9 10 11 12}

What is the purpose of this trial?

This trial is testing an online insomnia therapy program for veterans, especially those in rural areas. The program includes sleep improvement techniques and phone support from a coach to help veterans stay engaged. The goal is to make it easier for veterans to access effective insomnia treatment.

Research Team

Eric Hermes, MD

Principal Investigator

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Christi S. Ulmer, PhD

Principal Investigator

Durham VA Medical Center, Durham, NC

Eligibility Criteria

This trial is for Veterans with basic tech skills who have insomnia, want to try digital cognitive behavioral therapy (CBTi), and meet specific diagnostic criteria. It's not for those with recent shift work, psychotic/bipolar disorders, dementia, epilepsy, severe sleep apnea or undergoing PTSD exposure therapy.

Inclusion Criteria

Veterans who meet the ICSD-3 Insomnia disorder diagnostic criteria

Veterans who have basic technology literacy

I am a veteran interested in digital therapy for insomnia.

Exclusion Criteria

I am a veteran with dementia or moderate cognitive issues.

Veterans with epilepsy or seizure disorder

Veterans with nighttime or rotating shift work within the last 6 months

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-implementation

Initial enrollment contact and onboarding call for Digital CBTi with Coaching

2 weeks

1 visit (virtual)

Active Implementation

Participants receive Digital CBTi with Coaching, including two follow-up support calls

8 weeks

2 visits (virtual)

Maintenance

Ongoing support and monitoring of Digital CBTi with Coaching effectiveness

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Virtual Coaching

Trial Overview The DigIT Trial tests a Virtual Coaching program designed to support Veterans using a digital CBTi developed by VA. The study compares the effectiveness of this coaching intervention against an enhanced usual treatment without coaching.

Participant Groups

Group I: Digital CBTi with Coaching Experimental Treatment 1 Intervention

Virtual Coaching integrated with Digital CBTI. Includes initial enrollment contact, onboarding call, and two follow-up support calls. The coach will be available as resource for technical and other support.

Group II: Digital CBTi without Coaching (+ initial contact) Active Control 1 Intervention

The control will be an enhanced treatment as usual condition where participants will receive: 1) provider referral to Digital CBTi; 2) initial enrollment contact and 3) NO virtual coaching contacts. If subjects have a question or need technical support, they will be instructed to contact study staff for assistance.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

Before the release of the CBT-I Coach app, 87% of VA-trained clinicians believed it could improve insomnia treatment and intended to use it, indicating strong initial support for the app's potential benefits.

Two years post-release, nearly 60% of clinicians reported using the app with patients, noting positive effects on homework adherence and treatment outcomes, suggesting that the app effectively supports cognitive behavioral therapy for insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CBT-I Coach: A Description and Clinician Perceptions of a Mobile App for Cognitive Behavioral Therapy for Insomnia. Kuhn, E., Weiss, BJ., Taylor, KL., et al.[2018]

Digital cognitive behavioral therapy (dCBT) significantly improves functional health, psychological well-being, and sleep-related quality of life in adults with chronic insomnia, with these benefits sustained up to 48 weeks after treatment.

dCBT also reduces the use of both prescription and non-prescription sleep medications compared to sleep hygiene education, indicating its effectiveness in managing insomnia without relying heavily on medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term benefits of digital cognitive behavioural therapy for insomnia: Follow-up report from a randomized clinical trial. Luik, AI., Marsden, A., Emsley, R., et al.[2021]

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]

Telephone-based cognitive behavioral therapy for insomnia (CBT-I) significantly improved sleep quality in older adults with insomnia and osteoarthritis pain, with a mean reduction of 8.1 points on the Insomnia Severity Index (ISI) compared to 4.8 points in the education-only control group after 2 months.

The benefits of CBT-I were sustained at a 12-month follow-up, with 56.3% of participants in the CBT-I group remaining in remission, highlighting its effectiveness as a scalable treatment option for insomnia in underserved populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Telephone Cognitive Behavioral Therapy for Insomnia in Older Adults With Osteoarthritis Pain: A Randomized Clinical Trial. McCurry, SM., Zhu, W., Von Korff, M., et al.[2022]

A smartphone-based, culturally adapted digital cognitive behavioral therapy for insomnia (DCBT-I) significantly reduced insomnia severity compared to sleep education in a randomized trial with 82 participants over 6 weeks.

Participants in the DCBT-I group experienced greater improvements in total sleep time and sleep efficiency at both 3 and 6 months follow-up, indicating its efficacy in enhancing sleep quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Cognitive Behavioral Therapy for Insomnia Using a Smartphone Application in China: A Pilot Randomized Clinical Trial. Zhang, C., Liu, Y., Guo, X., et al.[2023]

Digital cognitive behavioral therapy (dCBT) significantly improves functional health, psychological well-being, and sleep-related quality of life in individuals with insomnia, based on a study of 1711 participants over 24 weeks.

The reduction in insomnia symptoms was a key factor mediating these improvements, highlighting that dCBT effectively addresses both daytime and nighttime issues related to poor sleep.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Digital Cognitive Behavioral Therapy for Insomnia on Health, Psychological Well-being, and Sleep-Related Quality of Life: A Randomized Clinical Trial. Espie, CA., Emsley, R., Kyle, SD., et al.[2023]

Digital cognitive behavior therapy for insomnia (dCBT-I) significantly improves sleep quality in patients with insomnia, particularly in those with anxiety disorders, as shown in a study of 6,002 patients over a 12-week period.

Patients receiving dCBT-I monotherapy and those with combined therapy showed notable improvements in sleep quality, with the most significant changes observed in the anxiety group, indicating that dCBT-I is a practical and effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital cognitive behavior therapy for insomnia improving sleep quality: a real-world study. Liang, S., Mao, H., Yang, J., et al.[2022]

References

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

CBT-I Coach: A Description and Clinician Perceptions of a Mobile App for Cognitive Behavioral Therapy for Insomnia. [2018]

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

Is a video-based cognitive behavioral therapy for insomnia as efficacious as a professionally administered treatment in breast cancer? Results of a randomized controlled trial. [2022]

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

Long-term benefits of digital cognitive behavioural therapy for insomnia: Follow-up report from a randomized clinical trial. [2021]

4. 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]

5. 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]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Digital cognitive behavioral therapy for insomnia - The first Georgian version. Can we use it in practice? [2020]

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

Effect of Telephone Cognitive Behavioral Therapy for Insomnia in Older Adults With Osteoarthritis Pain: A Randomized Clinical Trial. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Training of professionals in cognitive behavioural therapy for insomnia - A systematic review of peer-reviewed studies. [2023]

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

Digital Cognitive Behavioral Therapy for Insomnia Using a Smartphone Application in China: A Pilot Randomized Clinical Trial. [2023]

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

Effect of Digital Cognitive Behavioral Therapy for Insomnia on Health, Psychological Well-being, and Sleep-Related Quality of Life: A Randomized Clinical Trial. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Digital cognitive behavior therapy for insomnia improving sleep quality: a real-world study. [2022]

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

Integrating technology to increase the reach of CBT-I: state of the science and challenges ahead. [2023]