0977 A Non-Pharmacological Insomnia Treatment for Suicidal Behavior in High-Risk Civilians: An Open-Label Clinical Trial
Authors: Bernert Rebecca , Soltani Shamsi , Pham Savannah , Hom Melanie , Frank Ellen , Swartz Holly , Schatzberg Alan , Manber Rachel , Germain Anne , Krakow Barry , Brown Gregory , Neri Eric , Jo Booil , Tomlinson Megan Chavez , Hilberg Amanda 
Published: April 2024

Abstract

Introduction
Suicide has emerged as a public health crisis, where interventions remain scarce, unacceptable, and inaccessible to those high in need. By comparison, poor sleep is non-stigmatizing, visible, and highly treatable as a risk factor and transdiagnostic intervention target in suicide prevention. Aim 1: To develop, manualize, and test feasibility of a sleep-oriented treatment for suicidal behaviors within an open label clinical trial. Aim 2: To test antisuicidal response and indications of efficacy posttreatment across primary (suicidal ideation), secondary (sleep indices), and exploratory (mood indices) outcomes.

Methods
A multicomponent selective treatment was developed integrating: CBT for Insomnia (CBTi), Imagery Rehearsal Treatment (IRT), and Social Rythyms Treatment (SRT) (to address insomnia, nightmares, sleep variability) within an abbreviated (5-session) format (iSleep: Insomnia Treatment for Improved Well-Being). Treatment was manualized across session-by-session materials (powerpoints, homework, therapist guidesheets). Participants were enrolled based on screening and inclusion criteria: (a) age &gt;18, (b) clinically-significant sleep disturbance (Insomnia Severity Index (ISI&gt;10)); Pittsburgh Sleep Quality Index (PSQI&gt;5)), (c) DSM-V-Defined Major Depressive Disorder, (d) current suicidal ideation (Columbia Suicidal Severity Rating Scale (CSSRS&gt;1)). Comprehensive data and safety monitoring procedures were used to support risk assessment, triage, and outpatient safety planning. Outcomes were assessed at Baseline, Treatment, and Posttreatment (1,3 mos) timepoints.

Results
Of n=590 new contacts, n=310 participants were screened for high suicide risk. Fifty-nine participants were interviewed by full-battery eligibility assessment, resulting in n=35 participants enrolled for treatment allocation. Feasibility analyses demonstrated high rates of acceptance, tolerability, and safety. Paired t-tests revealed large posttreatment reductions in suicidal ideation (CSSRS, p&lt;.001), in addition to secondary outcomes of sleep disturbance (ISI, p&lt;.001; DDNSI, p&lt;.001) and depression (QIDS-SR, p&lt;.001). Effects were large and sustained through study follow up.

Conclusion
A non-pharmacological insomnia intervention (iSleep Treatment) resulted in antisuicidal symptom response and posttreatment improvements in sleep and overall well-being. Effects were large and observed across primary, secondary, and exploratory outcomes. This is the first known report testing use of a newly-developed, multicomponent insomnia treatment within an open label suicide prevention clinical trial, demonstrating excellent feasibility, safety, and therapeutic impact to suicidal risk.

Support (if any)
Work was supported by NIH (K23MH093490) and DOD/MOMRP/MSRC funding (W81XWH-10-2-0178)