Digital Cognitive Behavioral Therapy with Coaching for Insomnia

(DigIT Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of a digital cognitive behavioral therapy program for insomnia when paired with virtual coaching. The goal is to determine if Veterans using the digital program with coaching sleep better than those using the program without coaching. The trial targets Veterans with insomnia who are interested in this therapy and can use basic technology like smartphones or computers. It aims to enhance Veterans' use of the program and healthcare providers' adoption of it. As an unphased trial, this study offers Veterans the chance to contribute to innovative research that could improve insomnia treatment options.

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 prior data suggests that this virtual coaching intervention is safe for Veterans?

Research shows that digital Cognitive Behavioral Therapy for insomnia (dCBTi) is safe and well-tolerated. Studies have found that dCBTi does not cause significant side effects. Many people, including nurses with shift work disorder, have used digital CBTi to manage insomnia without major safety concerns.

Virtual coaching added to dCBTi aims to increase its effectiveness by providing extra support. This coaching includes phone calls and technical assistance, enhancing the therapy's impact. Reports have not indicated that coaching introduces any safety risks.

Overall, both digital CBTi and the coaching are considered safe based on current evidence. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for insomnia, which often involve medication or in-person therapy, Digital Cognitive Behavioral Therapy with Coaching offers a virtual, interactive approach. This treatment combines digital CBT methods with personalized coaching, providing an accessible and supportive experience. Researchers are excited because this method allows users to engage with therapy at their own pace and receive real-time support, potentially improving adherence and outcomes. The convenience of virtual access and the added layer of coaching make this approach stand out as a promising alternative to conventional insomnia treatments.

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

Research shows that digital cognitive behavioral therapy for insomnia (CBTi) can improve sleep by changing habits and thoughts that affect it. In this trial, participants will join one of two groups: one receiving Digital CBTi with Coaching and the other without Coaching. Studies have found that adding coaching to digital CBTi enhances its effectiveness. For example, coaching helps people stick with the program and boosts the treatment's overall success. In a small study with the Veterans Health Administration, this combination helped veterans sleep better. Early results suggest that coaching keeps users engaged and leads to better sleep outcomes. ^{1 2 4 6 7}

Who Is on the Research Team?

Christi S. Ulmer, PhD

Principal Investigator

Durham VA Medical Center, Durham, NC

Eric Hermes, MD

Principal Investigator

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

Are You a Good Fit for This Trial?

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

Veterans with epilepsy or seizure disorder

I am a veteran with dementia or moderate cognitive issues.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05558475

The Effectiveness and Implementation of a Coached Digital ... The study will evaluate the effectiveness and implementation of a Virtual Coaching Intervention to enhance use of a digital intervention delivering ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9978641/

The Implementation and Effectiveness of Digital Cognitive ... This pilot study assessed the feasibility of implementing a digital CBTi in Veterans Health Administration (VA) primary care through iterative modifications.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11339566/

Assessing the Short-Term Efficacy of Digital Cognitive ... This study examines whether adding chatbot-based and human coaching would improve the treatment efficacy of, and adherence to, dCBTi.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2667343623000069

Effectiveness of digital cognitive-behavioral therapy for ... This was a real-world evidence study aimed to evaluate the efficacy of a CBTi smartphone app combined or not with sleep medication.

5. aasm.org aasm.org/digital-cognitive-behavioral-therapy-for-insomnia-platforms-and-characteristics/

Digital cognitive behavioral therapy for insomnia This article aims to provide AASM members a better understanding of the currently available dCBT-I technologies and familiarity with online ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2590142725000205

Internet-delivered Cognitive Behavioral Therapy for Insomnia Sleepio is a CBTI-based digital sleep treatment tool that uses artificial intelligence to analyze users' sleep data and provide personalized ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11596998/

Digital cognitive behavioural therapy for insomnia reduces ... Digital cognitive behavioural therapy for insomnia reduces insomnia in nurses suffering from shift work disorder: A randomised‐controlled pilot trial