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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
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
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)
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.
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.
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.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,653 Previous Clinical Trials
3,360,755 Total Patients Enrolled
27 Trials studying Insomnia
4,286 Patients Enrolled for Insomnia
Eric Hermes, MDPrincipal InvestigatorVA Connecticut Healthcare System West Haven Campus, West Haven, CT
2 Previous Clinical Trials
77 Total Patients Enrolled
1 Trials studying Insomnia
77 Patients Enrolled for Insomnia
Christi S. Ulmer, PhDPrincipal InvestigatorDurham VA Medical Center, Durham, NC
2 Previous Clinical Trials
182 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a veteran with dementia or moderate cognitive issues.I am a veteran interested in digital therapy for insomnia.I am a veteran currently in exposure therapy for PTSD.I am interested in digital cognitive behavioral therapy for insomnia.
Research Study Groups:
This trial has the following groups:- Group 1: Digital CBTi with Coaching
- Group 2: Digital CBTi without Coaching (+ initial contact)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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