SHADES Mechanistic Trial (SHADES)
Insomnia, Insomnia Chronic, Insomnia, Primary
About this trial
This is an interventional prevention trial for Insomnia focused on measuring Primary Care, Internet Interventions, Cognitive-Behavioral Therapy for Insomnia, Insomnia, Cardiovascular Diseases
Eligibility Criteria
Inclusion criteria: Current primary care patient in Eskenazi Health Age ≥40 years Current insomnia disorder: During screening, ResNet assistants will administer the Insomnia Severity Index (ISI), a validated screener in primary care. Patients who have ISI scores ≥10 (97% sensitivity, 64% specificity) and remain eligible after ResNet screening will be called by our Insomnia Clinical Specialist, who will administer the Structured Clinical Interview for DSM-5 Sleep Disorders to confirm insomnia disorder. Elevated CVD risk: Elevated CVD risk will be defined as ≥2 (if 40-59 years) or ≥1 (if 60+ years) of the following risk factors in the Eskenazi Health EHR in the past 5 years: hypertension, hypercholesterolemia, diabetes, or smoking. Exclusion criteria are: History of clinical CVD: a self-reported CVD diagnosis during screening or any of the following in the patient's electronic health record before enrollment: myocardial infarction, unstable angina, coronary artery disease, cerebrovascular disease, heart failure, percutaneous coronary intervention, or coronary artery bypass graft Sleep disorder diagnosis other than insomnia (e.g., sleep apnea) Continuous positive airway pressure (CPAP) use or a STOP-BANG Questionnaire score ≥5, which is indicative of high probability of sleep apnea A schedule requiring a usual bedtime earlier than 8:00pm or later than 2:00am or arising time earlier than 4:00am or later than 10:00am Major inflammatory conditions (HIV/AIDS, chronic kidney disease, systemic inflammatory disease, or active cancer) Current pregnancy Severe cognitive impairment (≥3 errors on a validated 6-item cognitive screen) History of bipolar disorder or psychosis Acute risk of suicide
Sites / Locations
- Department of Psychology, School of Science, IUPUI
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
SHADES Intervention
Active Control
The SHADES intervention is a 6-month, modernized, collaborative care intervention in which a multidisciplinary team delivers established insomnia treatments consistent with patient preference. It uses a stepped, flexible, treat-to-target approach that harnesses technology to maximize access to and convenience of effective treatments and to minimize personnel, training, and space requirements. Our Intervention Team consists of an insomnia clinical specialist, a clinical behavioral sleep medicine and CBT-I delivery expert, a sleep research/medicine expert, and the patients' primary care providers. Treatments to be delivered are CBT-I in different modalities - internet, phone, and face-to-face - all of which are empirically supported.
Active Control (AC) consists of sleep education and hygiene (study staff), symptom monitoring (study staff), and usual primary care for insomnia (clinical staff).