Digital CBTI for Chronic Insomnia

N/A

Recruiting

Led By Anne Germain

Research Sponsored by Noctem, LLC

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 3-month follow up

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if using an online platform for Cognitive Behavioral Treatment of Insomnia is as effective as the standard care for insomnia in military facilities. They will compare the two methods in terms of improving

Who is the study for?

This trial is for active duty service members aged 18 or older who have chronic insomnia and are cleared for Cognitive Behavioral Treatment of Insomnia (CBTI). They must not have any serious health issues that could affect their safety, and if they're taking sleep meds, the dose must be stable for at least 4 weeks. Participants also need a recent smartphone.

What is being tested?

The study compares traditional insomnia care at military facilities with a new digital platform called COAST-enhanced CBTI to see which is better for treating insomnia, depression, anxiety symptoms, and patient satisfaction.

What are the potential side effects?

Since this trial involves cognitive behavioral therapy delivered digitally rather than medication, side effects may include discomfort from discussing personal issues or using technology but typically do not involve physical side effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-month follow up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3-month follow up

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-month follow up for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Acceptability of Insomnia Care

Insomnia Severity

Satisfaction with Insomnia Care

+2 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Active Control

Group I: COAST-enhanced CBTIActive Control1 Intervention

Patients randomized to COAST will receive CBTI via the COAST platform, with the assistance of a licensed clinician via NOCTEM's digital sleep hub. Participants will utilize the COAST patient app on their smartphone for engagement in insomnia treatment and receipt of clinician's recommendations. COAST clinicians will utilize the COAST web-based portal for adherence monitoring, progress review, and for providing personalized insomnia treatment recommendations.

Group II: Military Treatment Facility Insomnia Care As UsualActive Control1 Intervention

Patients randomized to the ICAU arm will receive insomnia care as usual by a certified clinician at their respective site, according to current referral and treatment practices.

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