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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
188
Participants will receive CBTI delivered through the COAST platform by one of NOCTEM's certified and licensed COAST clinician. Communication between the participant and licensed clinician will occur primarily through COAST's HIPAA-compliant text messaging, but clinicians and patients may elect to connect via telephone calls or HIPAA-compliant secure videoconference if needed.
Participants will receive the insomnia care offered at their site following current delivery practices (i.e., face-to-face or virtual; individual or group format). During the treatment phase, participants randomized to ICAU will be instructed to communicate with their clinicians as needed, according to standard procedures in place.
Madigan Army Medical Center
Lakewood, Washington, United States
RECRUITINGInsomnia Severity
Insomnia Severity Index (ISI)
Time frame: baseline
Insomnia Severity
Insomnia Severity Index (ISI)
Time frame: 6-8 week check-in
Insomnia Severity
Insomnia Severity Index (ISI)
Time frame: 3-month follow up
Symptoms of Depression
Patient Health Questionnaire-2 (PHQ-2)
Time frame: baseline
Symptoms of Depression
Patient Health Questionnaire-2 (PHQ-2)
Time frame: 6-8 week check-in
Symptoms of Depression
Patient Health Questionnaire-2 (PHQ-2)
Time frame: 3-month follow up
Symptoms of Anxiety
Generalized Anxiety Disorder 2-item (GAD-2)
Time frame: baseline
Symptoms of Anxiety
Generalized Anxiety Disorder 2-item (GAD-2)
Time frame: 6-8 week check-in
Symptoms of Anxiety
Generalized Anxiety Disorder 2-item (GAD-2)
Time frame: 3-month follow up
Acceptability of Insomnia Care
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).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 6-8 week check-in
Satisfaction with Insomnia Care
Client Satisfaction Questionnaire assessing perceived quality of care, services, and clinicians encountered during treatment.
Time frame: 6-8 week check in