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IIR 17-201 – HSR&D Study

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IIR 17-201
Combined Transcranial Magnetic Stimulation and Brief Cognitive Therapy to Reduce Suicide Behavior in High-Risk Veterans
Jennifer Marie Primack PhD MA
Providence, RI
Funding Period: May 2019 - April 2023

Abstract

The goal of the proposed study is to test the effect of adding repetitive Transcranial Magnetic Stimulation (TMS) to Brief Cognitive Behavioral Therapy (BCBT) to reduce Veterans' rates of suicide ideation and related behaviors. Over 20 Veterans die each day of suicide and rates have not appreciably decreased in the last ten years. [BCBT is a well-established and efficacious treatment that is an extension of Cognitive Behavioral Therapy, a treatment that is widely implemented across VA health care systems]. However, not all patients respond to BCBT. Thus finding ways to enhance treatment efficacy for reducing suicide is critical. TMS may be an optimal treatment to use in conjunction with psychotherapy. TMS is a noninvasive technique that uses a pulsed magnetic field to induce neuronal depolarization in a targeted brain region, typically the left dorsolateral prefrontal cortex. TMS can reduce psychiatric symptoms associated with suicide risk in Veterans, including depression and PTSD. Furthermore, TMS is not associated with the systemic and costly side effects associated with medications used for these disorders (e.g., weight gain, diabetes, sexual side effects). The Aim of this study is to conduct a fully powered randomized controlled trial evaluating the effect of adding a standard TMS course of treatment to BCBT to reduce suicide behaviors in a sample of Veterans hospitalized for suicide behavior. One hundred and thirty (130) Veterans admitted to the psychiatric unit for suicide ideation or attempts will be randomized to active TMS plus BCBT or to sham TMS plus BCBT. Participants will be assessed at baseline, post-treatment, six, and 12 months post hospital discharge. Efficacy of the program will be determined by examining a primary suicide composite outcome and several secondary outcomes including [suicide attempt, time to first attempt, number of re-hospitalizations and severity and severity of suicidal ideation]. Secondary analyses will be conducted to help identify the types of patients who will receive the most benefit from the addition of TMS to BCBT Brief Cognitive Behavioral Therapy for suicide. If successful, this study would result in a combined treatment to decrease suicide ideation and related behaviors. The proposal addresses HSRD post-deployment health priority, specifically suicide prevention and is innovative in that it will be the first study to examine efficacy of combined treatment specifically for suicide prevention. [If successful, next steps include dissemination and implementation throughout the VA in coordination with our local VISN and VA operations. Results will be used to work with partners to implement the intervention in multiple VAMC centers and target SAIL metrics such as re-admission rates and patient mortality. Consultation with VISN, VACO, and the suicide prevention MIRECC will be utilized to implement the treatment program across the VA. A partnered QUERI application will be submitted if results demonstrate promise.]

NIH Reporter Project Information: https://projectreporter.nih.gov/project_info_description.cfm?aid=9718531

PUBLICATIONS:
None at this time.

DRA: Mental, Cognitive and Behavioral Disorders
DRE: Treatment - Efficacy/Effectiveness Clinical Trial, TRL - Applied/Translational
Keywords: Suicide
MeSH Terms: None at this time.