Comparing Insomnia Care As Usual to Digital Augmentation (CICADA)
Chronic Insomnia
About this trial
This is an interventional treatment trial for Chronic Insomnia focused on measuring Insomnia, Cognitive Behavioral Therapy for Insomnia (CBTI), Digital Technology, Adherence Monitoring
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
COAST-enhanced CBTI
Military Treatment Facility Insomnia Care As Usual
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.
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.