Last updated: March 19, 2024
Sponsor: Noctem, LLC
Overall Status: Active - Recruiting
Phase
N/A
Condition
Restless Leg Syndrome
Insomnia
Treatment
COAST-enhanced CBTI
Military Treatment Facility Insomnia Care As Usual
Clinical Study ID
NCT05490550
JW210372
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Active duty service members, men and women, diagnosed with chronic insomnia and deemedeligible for CBTI by their treating clinician.
- Age 18 or older.
- Absence of, or stable, psychiatric, or medical comorbidity(ies), such that they do notcompromise safety when completing study procedures.
- If using prescribed sleep medication(s), have received the medication(s) at a stabledosage for at least 4 weeks, with no scheduled change in medication or dosage over theacute intervention phase (up to 12 weeks)
- Owning or ability to use a smartphone (iPhone or Android) that is no older than 5years old (e.g., iPhone 6, and Android phone with Lollipop 5.0 mobile operatingsystem)
Exclusion
Exclusion Criteria:
- Presence of an untreated or under-treated comorbid sleep disorder that requiresindependent treatment or that may be exacerbated by sleep restriction or stimulicontrol, e.g., obstructive sleep apnea (OSA) or rapid-eye-movement (REM) behaviordisorder or sleep walking with a history of injury to self or others.
- Acute psychiatric distress associated with marked impairments in functioning or thatlimits engagement in CBTI, adversely impacts the risk/benefit ratio of participatingin the study, or requires immediate attention, as indicated by, but not limited to,the examples listed below. Please note that each referring clinician will determinewhether 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 thatrequires inpatient or partial hospitalization level of psychiatric care.
- Currently requiring the support of an assigned case manager for services such ascoordination of medications, appointments, transportation, and/or for completingactivities of daily living.
- Active substance use disorder.
- Past or current psychotic or bipolar disorder or sub-threshold symptoms of psychoticor 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 CPAPuse per night).
- Anticipates relocating/moving out of state in the next 3 months
Study Design
Total Participants: 188
Treatment Group(s): 2
Primary Treatment: COAST-enhanced CBTI
Phase:
Study Start date:
August 16, 2023
Estimated Completion Date:
March 31, 2025
Study Description
Connect with a study center
Madigan Army Medical Center
Lakewood, Washington 98431
United StatesActive - Recruiting
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