The overarching goal of this Mentored Patient-Oriented Research Career Development Award (K23) is to provide the Candidate with comprehensive training to facilitate her independence as an investigator within two distinct, but intersecting fields of study: sleep medicine and suicide prevention. Suicide is a complex, but preventable public health problem, for which research-tested interventions are scarce. Poor sleep has emerged as an empirically-established, modifiable suicide risk factor that is visible, amenable to treatment, and arguably less stigmatized compared to other risk factors. The current proposal will pursue rigorous evaluation of sleep as an intervention tool.
It aims to develop a sleep-oriented intervention for suicidal behaviors. A programmatic line of research is proposed to endow the Candidate with critical methodological training in treatment development. Both education and research training plans will cultivate her independence as trialist and suicide preventionist. Using a multidisciplinary approach, the proposed education plan offers career development training across three general areas: (1) Randomized controlled trials (RCT) (design, conduct, analysis) using behavioral interventions, (2) Treatment development methods (manualizing, pilot-testing interventions) in sleep and suicide prevention, and (3) Emotion regulation research to evaluate underlying causal mechanisms, and potential intervention targets, in the study of sleep and suicide risk. Consultation, coursework, didactics, and applied trainings will enable the Candidate to acquire advanced conceptual, methodological, and biostatistical skills across specialty areas. Next, based on theoretical, empirical, and clinical rationale, the proposed research plan outlines two pilot studies to develop a new, sleep-based suicide intervention (SBSI). Development of a novel preventive intervention among this high-risk population is in accordance with several NIMH Strategic Plan Objectives. It will endow the Candidate with applied and explicit training in treatment development and RCT conduct. Study 1 will be a small, open-label pilot focused on SBSI development. SBSI will target sleep complaints known to present risk for suicide by integrating core components from three efficacious treatments: Cognitive behavioral therapy for insomnia (CBT-I) will address insomnia symptoms, social rhythms therapy (SRT) will address irregular sleep patterns, and imagery rehearsal treatment (IRT) will address residual nightmares. The protocol will be manualized, evaluated for feasibility, and revised based on focus groups, acceptance, and indications of response. Study 2 will be a randomized controlled pilot study. It will compare SBSI to an active control to evaluate feasibility, acceptance, retention, and preliminary indications of response. To promote the Candidate's career independence, results from these studies are expected to result in application for an R01 RCT in suicide prevention.
Suicide represents a global disease burden that, despite improvements in awareness and treatment, continues to account for more than half of all violent deaths worldwide. In this important research area, even modest symptom improvements may have great clinical significance when the potential outcome to be prevented is death. Given its target of a uniquely modifiable suicide risk factor, development of a novel sleep-based intervention for suicide has public health significance by addressing a gap in the literature wherein efficacious treatments are either few in number, unacceptable to patients (i.e., based on retention rates), or inaccessible to those most in need.
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