Combined Transcranial Magnetic Stimulation and Brief Cognitive Therapy to Reduce Veteran Suicide
Combined Transcranial Magnetic Stimulation and Brief Cognitive Therapy to Reduce Veteran Suicide
批准号:
10209958
负责人:
Noah Stephen Philip
金额:
$0.0万
依托单位国家:
美国
项目类别:
财政年份:
2019
资助国家:
美国
项目状态:
已结题
起止时间:
2019-05-01 至 2024-04-30
关键词:
AddressAdmission activityAftercareBehaviorBlindedBrain regionCessation of lifeClinicalCognitive TherapyCombined Modality TherapyConduct Clinical TrialsConsultationsCountryDiabetes MellitusDiagnosisDiseaseDissemination and ImplementationEffect Modifiers (Epidemiology)EffectivenessEnrollmentFeeling suicidalGenderGoalsGrowthHealth PrioritiesHealthcare SystemsHospitalizationHospitalsInpatientsInterventionLeftMajor Depressive DisorderMediatingMediatorMedical centerMental DepressionMilitary PersonnelModalityModelingNeuronsOutcomeParticipantPatientsPharmaceutical PreparationsPhysiologic pulsePost-Traumatic Stress DisordersPrefrontal CortexPsychotherapyRandomizedRandomized, Controlled TrialsSamplingSeveritiesSuicideSuicide attemptSuicide preventionSystemTechniquesTestingTimeTranscranial magnetic stimulationTreatment EfficacyTreatment outcomeUnited States Department of Veterans AffairsVeteransVisitWeight GainWorkassociated symptombrief interventioncomorbiditycostefficacious treatmentefficacy evaluationfollow-uphigh riskhospital readmissionimprovedinnovationmagnetic fieldmortalitynoveloperationoptimal treatmentsprogramspsychiatric symptompsychosocialreadmission ratesreduce symptomsreducing suiciderepetitive transcranial magnetic stimulationsecondary analysissecondary outcomeside effectstatisticssuicidalsuicidal behaviorsuicidal individualsuicidal risksuicide attemptersuicide ratetreatment program
中文摘要
这项拟议的研究的目标是测试增加重复的经颅磁场的效果
刺激(TMS)以简化认知行为疗法(BCBT)以降低退伍军人的自杀意念率
以及相关的行为。每年有20多名退伍军人自杀身亡,自杀率并没有明显下降
在过去十年里。[BCBT是一种成熟而有效的治疗方法,是认知的延伸
行为疗法,一种在退伍军人管理局卫生保健系统中广泛实施的治疗方法]。然而,并不是所有的
患者对BCBT有反应。因此,找到提高治疗效果以减少自杀的方法是至关重要的。
TMS可能是与心理治疗相结合的最佳治疗方法。TMS是一种非侵入性技术
它使用脉冲磁场在目标大脑区域(通常是左侧)诱导神经元去极化
背外侧前额叶皮质。TMS可以减少退伍军人与自杀风险相关的精神症状,
包括抑郁症和创伤后应激障碍。此外,TMS与系统性和代价高昂的副作用无关
与用于治疗这些疾病的药物(例如,体重增加、糖尿病、性副作用)有关。
本研究的目的是进行一项完全有效的随机对照试验,以评估
在BCBT基础上增加标准TMS疗程以减少退伍军人样本中的自杀行为
因自杀行为入院治疗。130名退伍军人住进精神病科
自杀意念或企图将随机分为积极TMS加BCBT组或假TMS加BCBT组。
参与者将在基线、治疗后、出院后6个月和12个月进行评估。功效
将通过检查初级自杀复合结局和几个继发性自杀综合结局来确定
结果包括[自杀未遂、首次自杀未遂的时间、再次住院的次数和严重程度
自杀意念的严重性]。将进行二次分析,以帮助确定哪些患者
将从将TMS添加到BCBT简明自杀认知行为疗法中受益最大。
如果成功,这项研究将导致一种联合治疗,以减少自杀意念和相关
行为。该提案涉及HSRD部署后的健康优先事项,特别是自杀预防和
创新之处在于,这将是第一个研究专门针对自杀的综合治疗效果的研究
预防。
[如果成功,下一步包括在整个退伍军人事务部协调传播和执行
与我们当地的VISN和退伍军人事务部合作。结果将用于与合作伙伴合作实施干预
在多个VAMC中心和目标SAIL指标,如再住院率和患者死亡率。
将利用与VISN、VACO和自杀预防MIRECC的协商来实施治疗
整个退伍军人事务部的项目。如果结果显示前景看好,将提交合作伙伴QUERI申请。]
英文摘要
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.]
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