PI: Rainish Mehrotra; Co-Investigators: Daniel Cukor, Patrick J. Heagerty, Susan M. McCurry, Mark Unruh
NIDDK/NIH R01 DK115468
Patients with end-stage renal disease treated with hemodialysis (HD) report poor health-related quality of life, in part because of the large number of troubling symptoms they experience. One of the most frequently reported such symptoms is insomnia, including patient difficulties in falling asleep, frequently waking up after falling asleep, and early morning awakening. There are unique issues pertaining to HD treatments and schedules that disrupt regular sleep/wake routines and contribute to the high prevalence and severity of insomnia. A large body of evidence from HD patients and other populations also indicate that insomnia is associated with fatigue, daytime sleepiness, pain, depressive symptoms, and a higher risk for death. Despite evidence for broad-ranging health effects of insomnia, no clinical trials have tested the efficacy of treatments for HD patients. Cognitive behavioral therapy for insomnia (CBT-I) is recommended as first line therapy but is inaccessible to HD patients in the United States as they have to commit to thrice weekly dialysis treatments in community-based dialysis facilities; CBT-I delivered by telehealth can overcome the barriers but its efficacy has never been rigorously tested for any patient population. Pharmacotherapy is the most widely used treatment for insomnia for HD patients. While some drugs presently used are unsafe as they are associated with a higher risk for death for this patient population (benzodiazepines and zolpidem-like drugs), the efficacy of others (trazodone) has never been tested for HD patients. With this application, we propose to test the short- and long-term comparative effectiveness of 6-week treatment with telehealth CBT-I, trazodone, or medication placebo. This will be accomplished with a randomized controlled clinical trials in which 125 HD patients with chronic insomnia treated in community-based dialysis facilities in Seattle and Albuquerque will be assigned 2:2:1 to telehealth CBT-I, trazodone, and medication placebo, respectively; short-term effectiveness will be determined at the end of 6 weeks of treatment and long-term effectiveness at 24 weeks. Telehealth CBT-I will be delivered through a mobile platform, iHOPE, by English and Spanish-speaking therapists. The primary and secondary patient reported outcomes will be assessed with computer-based telephone interviewing by research scientists blinded to treatment assignment. The study will be conducted under the oversight of highly experienced Clinical and Data Coordinating Centers in Seattle with a strong track record of patient enrollment and retention in clinical trials, and implementing behavioral interventions with high fidelity to the protocol. This clinical trial will provide the first evidence for the comparative effectiveness of two distinct approaches in improving insomnia and other patient-reported outcomes for HD patients. It will also be the first rigorous evaluation of telehealth CBT-I, a readily scalable approach not only for HD patients but also for other patient populations with difficulty accessing treatment for insomnia.