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Hypertension with unsatisfactory sleep health (HUSH): study protocol for a randomized controlled trial
Jessica C Levenson1, Bruce L Rollman2, Lee M Ritterband3
1Department of Psychiatry, University of Pittsburgh School of Medicine, 3811 O'Hara Street, E-1123 TDH, Pittsburgh, PA, 15213, USA.
Trials
|June 8, 2017
Summary
This study tested two behavioral insomnia treatments against usual care in adults with hypertension. Results will inform real-world sleep disorder treatment and implementation.
Area of Science:
- Clinical Trials
- Behavioral Sleep Medicine
- Primary Care Research
Background:
- Insomnia is prevalent in primary care, yet behavioral treatments are underutilized.
- Efficacy of insomnia treatments on comorbid medical conditions requires further investigation.
- This study addresses the gap in availability and understanding of behavioral insomnia interventions.
Purpose of the Study:
- To compare the efficacy of Brief Behavioral Treatment for Insomnia (BBTI) and Sleep Healthy Using the Internet (SHUTi) against enhanced usual care (EUC).
- To evaluate the impact of these interventions on sleep disturbances and comorbid conditions in adults with hypertension.
- To provide a pragmatic examination of two distinct cognitive behavioral therapy for insomnia (CBT-I) delivery methods.
Main Methods:
- A three-arm, parallel-group, randomized controlled trial involving 625 adults with hypertension and insomnia.
- Participants were randomized to BBTI (therapist-led telehealth), SHUTi (self-guided web-based CBT-I), or EUC (educational resources).
- Outcomes including sleep disturbances, home blood pressure, and quality of life were assessed at 9 weeks, 6 months, and 12 months.
Main Results:
- Primary outcome is patient-reported sleep disturbances.
- Secondary outcomes include home blood pressure, BMI, quality of life, and healthcare utilization.
- Data collection spans 12 months to capture long-term effects.
Conclusions:
- This pragmatic trial offers a cost-effective comparison of two efficacious insomnia interventions.
- Findings may influence the real-world delivery and implementation of behavioral sleep interventions in primary care.
- The study aims to advance the dissemination of evidence-based treatments for insomnia.
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