Comparing Insomnia Care As Usual to Digital Augmentation
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 188
- Locations
- 2
- Primary Endpoint
- Satisfaction with Insomnia Care
Study Overview
Brief Summary
The purpose of this pragmatic non-inferiority randomized clinical trial is to evaluate whether Cognitive Behavioral Treatment of Insomnia (CBTI) delivered through a clinical decision support digital platform is non-inferior to insomnia care delivered as usual at three military treatment facilities for treatment of insomnia, symptoms of depression and anxiety, and treatment satisfaction.
Detailed Description
Chronic insomnia is pervasive among service members and adversely affects health and readiness. Insomnia rarely remits spontaneously, and sleep-focused treatments are required to reduce or eliminate insomnia. Cognitive Behavioral Treatment of Insomnia (CBTI) is the first line treatment for insomnia. CBTI remains underutilized and is often unavailable in care settings where service members receive sleep healthcare. Digital health technology is one of the strategic components identified by the DHA to support behavioral health, including sleep health. NOCTEM® has developed and validated its Clinician Operated Assistive Sleep Technology (COAST™) platform to scale delivery and access to CBTI. This non-inferiority trial will evaluate and compare the changes in insomnia severity following COAST-enhanced CBTI or insomnia care as usual (ICAU) pre- to post-treatment and at the 3-month follow up. Secondary outcomes of interest include changes in depression and anxiety over time, and patient satisfaction with insomnia care following COAST-enhanced CBTI or ICAU.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Active duty service members, men and women, diagnosed with chronic insomnia and deemed eligible for CBTI by their treating clinician.
- •Age 18 or older.
- •Absence of, or stable, psychiatric, or medical comorbidity(ies), such that they do not compromise safety when completing study procedures.
- •If using prescribed sleep medication(s), have received the medication(s) at a stable dosage for at least 4 weeks, with no scheduled change in medication or dosage over the acute intervention phase (up to 12 weeks)
- •Owning or ability to use a smartphone (iPhone or Android) that is no older than 5 years old (e.g., iPhone 6, and Android phone with Lollipop 5.0 mobile operating system)
Exclusion Criteria
- •Presence of an untreated or under-treated comorbid sleep disorder that requires independent treatment or that may be exacerbated by sleep restriction or stimuli control, e.g., obstructive sleep apnea (OSA) or rapid-eye-movement (REM) behavior disorder or sleep walking with a history of injury to self or others.
- •Acute psychiatric distress associated with marked impairments in functioning or that limits engagement in CBTI, adversely impacts the risk/benefit ratio of participating in the study, or requires immediate attention, as indicated by, but not limited to, the examples listed below. Please note that each referring clinician will determine whether a patient is eligible for the study.
- •Having planned or attempted suicide or the harming of others in the past 6 months.
- •Seeking and/or receiving treatment at psychiatric clinic facility at a level that requires inpatient or partial hospitalization level of psychiatric care.
- •Currently requiring the support of an assigned case manager for services such as coordination of medications, appointments, transportation, and/or for completing activities of daily living.
- •Active substance use disorder.
- •Past or current psychotic or bipolar disorder or sub-threshold symptoms of psychotic or bipolar disorders.
- •Currently pregnant, breastfeeding, or being the parent of a newborn < 3 months old.
- •Untreated seizure disorder.
- •Suspected, diagnosed, or inadequately treated sleep apnea (less than 4 hours of CPAP use per night).
- •Anticipates relocating/moving out of state in the next 3 months
Arms & Interventions
COAST-enhanced CBTI
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.
Intervention: COAST-enhanced CBTI (Behavioral)
Military Treatment Facility Insomnia Care As Usual
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.
Intervention: Military Treatment Facility Insomnia Care As Usual (Behavioral)
Outcomes
Primary Outcomes
Satisfaction with Insomnia Care
Time Frame: 6-8 week check in
Client Satisfaction Questionnaire assessing perceived quality of care, services, and clinicians encountered during treatment.
Acceptability of Insomnia Care
Time Frame: 6-8 week check-in
An adapted version of the Insomnia Treatment Acceptability Scale (ITAS) with ratings of perceived acceptability and treatment preference for both COAST-enhanced CBTI and insomnia care as usual (ICAU).
Insomnia Severity
Time Frame: 3-month follow up
Insomnia Severity Index (ISI)
Symptoms of Depression
Time Frame: 3-month follow up
Patient Health Questionnaire-2 (PHQ-2)
Symptoms of Anxiety
Time Frame: 3-month follow up
Generalized Anxiety Disorder 2-item (GAD-2)
Secondary Outcomes
No secondary outcomes reported
Investigators
Anne Germain
NOCTEM Founder & CEO
Noctem, LLC