What is the mechanism of action of this treatment?

Cognitive Behavioral Therapy for Insomnia (CBT-I) is a structured program that helps individuals identify and replace thoughts and behaviors that cause or worsen sleep problems with habits that promote sound sleep. Key components include sleep restriction, stimulus control, cognitive restructuring, and relaxation techniques. Digital CBT-I programs make these interventions accessible online, while virtual coaching enhances engagement and adherence by providing personalized support and motivation. This matters for insomnia patients as it leads to more consistent application of therapeutic techniques, resulting in improved sleep quality and overall clinical outcomes.

What side effects are associated with this type of intervention?

Cognitive Behavioral Therapy for Insomnia (CBTi), including digital CBTi, is generally well-tolerated with minimal side effects. Some individuals may experience initial sleepiness or fatigue as they adjust to new sleep patterns. In contrast, pharmacologic treatments for insomnia, such as benzodiazepines and sedative-hypnotics, can have side effects including daytime drowsiness, dizziness, headache, and potential dependency. Non-pharmacologic interventions like relaxation techniques and sleep hygiene education are also used and typically have no significant side effects.

What prior FDA approvals exist?

The FDA has approved several pharmacological treatments for insomnia, including benzodiazepines (e.g., temazepam), non-benzodiazepine hypnotics (e.g., zolpidem, eszopiclone), and melatonin receptor agonists (e.g., ramelteon). Additionally, the FDA has recognized the efficacy of digital interventions like Cognitive Behavioral Therapy for Insomnia (CBTi), which can be enhanced through virtual coaching to improve engagement and adherence, leading to better clinical outcomes. These digital therapies focus on behavioral changes and sleep hygiene, offering a non-pharmacological approach to managing insomnia.

What other types of research exist?

Promising alternatives to Virtual Coaching Intervention for insomnia patients include: 1) Digital CBTi programs with integrated AI-driven personalized feedback, which can adapt the treatment based on user data and engagement patterns. 2) Mobile apps that incorporate gamification elements to increase user motivation and adherence. 3) Wearable devices that monitor sleep patterns and provide real-time feedback and recommendations. 4) Telehealth platforms offering remote CBTi sessions with licensed therapists, ensuring accessibility and personalized care. 5) Virtual reality-based CBTi, which can provide immersive environments to practice sleep hygiene and relaxation techniques.

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Digital Cognitive Behavioral Therapy with Coaching for Insomnia (DigIT Trial)

N/A

Waitlist Available

Led By Eric Hermes, MD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to 6 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves virtual coaching and digital therapy rather than medication, typical drug side effects are not expected. However, participants may experience discomfort from changes in their sleep habits due to CBTi techniques.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Insomnia Severity Index (ISI)

Secondary study objectives

Sleep Efficiency (SE)

Sleep Onset Latency (SOL)

Wake After Sleep Onset (WASO)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Digital CBTi with CoachingExperimental Treatment1 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 Control1 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.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cognitive Behavioral Therapy for Insomnia (CBT-I) is a structured program that helps individuals identify and replace thoughts and behaviors that cause or worsen sleep problems with habits that promote sound sleep. Key components include sleep restriction, stimulus control, cognitive restructuring, and relaxation techniques. Digital CBT-I programs make these interventions accessible online, while virtual coaching enhances engagement and adherence by providing personalized support and motivation. This matters for insomnia patients as it leads to more consistent application of therapeutic techniques, resulting in improved sleep quality and overall clinical outcomes.

Implementing internet-delivered cognitive behavioural therapy for patients with cardiovascular disease and psychological distress: a scoping review.Testing two types of self-help CBT-I for insomnia in older adults with arthritis or coronary artery disease.