Insomnia is a prevalent, chronic, and inadequately-treated chronic medical condition associated with comorbid conditions such as hypertension (HTN) and a range of adverse health outcomes. Hypnotic medications are efficacious and widely available, but they have potentially serious adverse effects. Patients and providers prefer non-drug treatments such as Cognitive-Behavioral Treatment of Insomnia (CBT-I), which is safe, efficacious, and durable-but not widely available. Innovative use of electronic health records (EHR) to identify patients, and the availability of new technologies that enable cognitive-behavioral interventions to be delivered at scale, with high treatment fidelity, and at low cost, offer exciting opportunities to address these critical problems. The investigators propose a low-cost, pragmatic, patient-centered, randomized controlled trial comparing two CBT-I-based interventions for insomnia with comorbid hypertension (INS+HTN) to primary care physicians' (PCP) enhanced usual care (EUC). The setting will be University of Pittsburgh Medical Center (UPMC) primary care practices. Participants will be 625 adults with INS+HTN. Recruitment will be conducted using alerts in the EpicCare EHR triggered by patient characteristics (hypertension; hypnotic medications or insomnia diagnosis/problem). The investigators will compare 3 interventions: Brief Behavioral Treatment of Insomnia (BBTI), involving electronic educational material and 4 telephone/web sessions with a live interventionist; "Sleep Healthy Using The Internet" (SHUTi), a self-guided, 8-module, Internet version of CBT-I, with no human contact; and EUC, which includes assessment and educational information for participants and providers. The primary outcome will be self-reported sleep at 9 weeks. Other outcomes include domains of symptoms, health, and patient/provider satisfaction obtained by self-report, home blood pressure monitoring (HBPM), and EHR. Specific Aims for the trial are: (1) To compare interventions on patient-reported symptoms at 9 weeks, 6 months, and 12 months. (2) To compare interventions on health indicators including self-report, HBPM, and EHR measures at 6 and 12 months. (3) To compare patient and provider-level satisfaction with the 3 interventions. (4) Exploratory Aim: To compare BBTI and CBT-I on each outcome domain and intervention adherence/drop-outs.
We made changes to the outcome measures document in April, 2019, and further amended these measures in June, 2019. The reason for these changes was to ensure consistency among the grant application, clinical trial protocol paper, and ClinicalTrials.gov. We made the following specific changes and corrections:
* Insomnia diagnosis, cumulative illness rating scale, and treatment expectations were removed as secondary outcomes, as they are not listed in our protocol as outcome measures. They are only measured at baseline to characterize participants.
* Health-Related Quality of Life "Medical Outcomes Survey Short Form-12 and Client Satisfaction "Client Satisfaction Questionnaire" were changed from primary to secondary outcome measures, to ensure consistency with the grant application and protocol paper.
* Side effects "Treatment-related Side Effects Scale" were changed from a secondary to an "other" outcome measure, again to ensure consistency with the grant application and protocol paper.
The following outcome measures were added to ClinicalTrials.gov to ensure consistency:
Secondary Outcome: Provider Satisfaction "Provider Satisfaction Survey"
Other Prespecified Outcome Measures:
* Daytime Impairment Related to Sleep "PROMIS Sleep Related Impairment"
* Insomnia Severity "Insomnia Severity Index"
* Sleep Quality "Pittsburgh Sleep Quality Index"
* Daytime Sleepiness "Epworth Sleepiness Scale"
* Falls "Side Effect/Falls Questionnaire" "Falls Follow-up Questionnaire"
* Improvement "Patient Global Impression of Improvement Scale"
* Sleep Diary Measures "HUSH Daily Diary"
We also recognized that we had erroneously interpreted "time frame" as the time frame of the instrument itself, rather than the time frame of the assessment battery. Time frames in ClinicalTrials.gov were corrected to capture the time points at which they are assessed, in the following measures:
* Sleep disturbance "PROMIS Sleep Disturbance Scale"
* Health related quality of life "Medical Outcomes Survey Short Form-12"
* Client satisfaction "Client Satisfaction Questionnaire"
* Depression "PROMIS Depression Scale"
* Anxiety "PROMIS Anxiety Scale"
* Fatigue "PROMIS Fatigue Scale"
* Blood pressure "HUSH Sleep Diary"
* Hypnotic use "Health Care Utilization Questionnaire" "HUSH Sleep Diary"
* Health care costs "Health Care Utilization Questionnaire"
* Side effects "Treatment-related Side Effects Scale"
