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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

DigIT Trial Summary

This trial will study whether providing coaching to Veterans using a digital cognitive behavioral therapy for insomnia program will help improve symptoms and sleep parameters compared to the digital program without coaching.

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.Check my eligibility

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.See study design

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.

DigIT Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Insomnia Severity Index (ISI)

Secondary outcome measures

Sleep Efficiency (SE)

Sleep Onset Latency (SOL)

Wake After Sleep Onset (WASO)

DigIT 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

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,609 Previous Clinical Trials

3,306,403 Total Patients Enrolled

27 Trials studying Insomnia

4,197 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

Virtual Coaching Clinical Trial Eligibility Overview. Trial Name: NCT05558475 — N/A

Insomnia Research Study Groups: Digital CBTi with Coaching, Digital CBTi without Coaching (+ initial contact)

Insomnia Clinical Trial 2023: Virtual Coaching Highlights & Side Effects. Trial Name: NCT05558475 — N/A

Virtual Coaching 2023 Treatment Timeline for Medical Study. Trial Name: NCT05558475 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many medical facilities in the state are currently conducting this clinical experiment?

"This clinical trial is taking place in multiple locations, including West Haven, Connecticut; White River Junction, Vermont; and Leeds, Massachusetts. VA Connecticut Healthcare System West Haven Campus, West Haven CT, White River Junction VA Medical Center in White River Junction VT., as well as VA Central Western Massachusetts Healthcare System in Leeds MA are amongst the five other sites participating in this research."

Answered by AI

To whom is this experiment open for participation?

"This clinical trial requires 200 individuals of ages 18 to 100 that suffer from insomnia disorder, as outlined by the ICSD-3 classification system. Additionally, participants must have an affinity for digital Cognitive Behavioral Therapy Interventions (CBTi) and possess a fundamental understanding of technology."

Answered by AI

Does this medical experiment have an age limit of 80 or below for participants?

"This clinical study is recruiting participants of age 18 or higher, but not exceeding a century in years."

Answered by AI

Are there still openings available in this experiment for participants?

"According to clinicaltrials.gov, this particular trial is no longer recruiting any participants; it was published on April 3rd 2023 and last updated in September of 2022. Nonetheless, there are still 210 other trials that require volunteers at the present time."

Answered by AI

Who else is applying?

What state do they live in?

New Hampshire

What site did they apply to?

Manchester VA Medical Center, Manchester, NH

What portion of applicants met pre-screening criteria?

Did not meet criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

I have suffered with idiopathic insomnia for over 30 years. I am not a veteran, but my husband receives VA health care. I live in Goffstown, NH and am desperate to find a Cognitive Behavior Therapy as the medications I have been on for years do not help. I take Trazadone and nortriptyline to sleep, then Modafinil during the day to keep me awake. When I wake up, I am as exhausted as I was before I went to sleep.

PatientReceived 1 prior treatment

Recent research and studies

clinicaltrials.govStudy

The DigIT Trial: The Effectiveness and Implementation of a Coached Digital Insomnia Treatment Program in a Regional Healthcare System.

2023. "The DigIT Trial: The Effectiveness and Implementation of a Coached Digital Insomnia Treatment Program in a Regional Healthcare System.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05558475.

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