Combined Transcranial Magnetic Stimulation and Brief Cognitive Therapy to Reduce Suicide Behavior in High-Risk Veterans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Columbia Suicide Severity Rating Scale (CSSRS) (Suicide Composite)
研究概览
简要总结
High rates of Veteran suicide remain a tragedy. Rates of Veteran suicide have not decreased for 10 years, despite the best efforts of the field. Those interventions that do exist have only modest effects, which are simply insufficient for the magnitude of the problem. This proposal will combine two treatments - brief cognitive behavioral therapy (BCBT) and repetitive transcranial magnetic stimulation (TMS). Both of these interventions can reduce suicide and are available at Veterans Affairs Medical Centers across the country, yet to date no one has combined these therapies. This proposal will test the effect of this combination, and, if successful, will lead to a novel yet implementable new treatment to reduce Veteran suicide.
详细描述
The goal of the proposed study is to test the effect of adding 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. Transcranial Magnetic Stimulation (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 primary objective 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 randomly assigned to either 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Prior to each TMS session, un-blinded study staff will attach the appropriate (i.e., active or sham) coil according to the participants' randomization code (obtained from the urn randomization computer program). This will facilitate "triple blind" stimulation, where the participant, TMS provider, and outcome rater are blind to group assignation.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suicide attempt or suicidal ideation with intent to make a suicide attempt within 48 hours of hospitalization as indicated on the hospital chart and confirmed by administration of the C-SSRS.
排除标准
- •Primary psychotic disorder
- •Bipolar disorder
- •Cognitive impairment which would interfere with adequate participation in the project (MMSE < 20).
- •For safety, participants must meet established screening criteria safety during MRI, which is implemented as a conservative measure given the application of TMS in this population, since MRI involves magnetic fields at similar intensity to those emitted from the stimulation coil. These measures require a patient not having the following (unless MRI-safe):
- •Cardiac pacemaker
- •Implanted device (deep brain stimulation) or metal in the brain, cervical spinal cord, or upper thoracic spinal cord.
- •TMS-specific exclusions are:
- •pregnancy/lactation, or planning to become pregnant during the study
- •lifetime history of moderate or severe traumatic brain injury (TBI)
- •Current unstable medical conditions
- •Current (or past if appropriate) significant neurological disorder
- •Lifetime history seizure disorder
- •Primary or secondary CNS tumors
- •Cerebral aneurysm.
- •Other exclusions are conditions that would like to be worsened by TMS, such as bipolar disorder
- •Place Veterans at greater risk of seizures from TMS, such as severe and uncontrolled substance use disorder
- •Inability to participate in CBT
- •Other conditions or circumstance that, in the opinion of the investigator team, has the potential to prevent study completion and/or to have a confounding effect on outcome assessments
结局指标
主要结局
Columbia Suicide Severity Rating Scale (CSSRS) (Suicide Composite)
时间窗: Baseline, endpoint (end of 12-week BCBT course), 6-month follow-up, and 12 month follow up
The Columbia suicide severity rating scale is an interview-administered assessment of suicide ideation and behavior. The full CSSRS interview consists of two subscales, an ideation and behavior subscale. The primary outcome measure for this study utilized the behavior subscale. A study-created composite score was calculated by adding the total number of: 1) suicide attempts, 2) interrupted attempts, and 3) aborted attempts in the specified time frame. At baseline total number of behaviors covered lifetime number of total behaviors prior to baseline. Each subsequent assessment period assesses total number of behaviors since time of last assessment (e.g., endpoint = total number of behaviors from baseline to end of 12-week BCBT course, 6-month follow up = total number of behaviors from endpoint to 6 months post-baseline, 12 months = total number of behaviors from 6 month follow up to 12 month follow up.
次要结局
- Beck Scale for Suicide Ideation (BSSI)(Baseline, endpoint (end of 12-week BCBT course), 6-month follow-up, and 12 month follow up)
- The Longitudinal Interval Follow-up Evaluation (LIFE): Psychiatric Status Rating Scale for Suicidal Ideation(Endpoint (end of 12-week BCBT course), 6-month follow-up, and 12 month follow up)
- Change in World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)(Baseline, endpoint (end of 12-week BCBT course), 6-month follow-up, and 12 month follow up)
- Treatment History Interview THI: Emergency Services(Endpoint (following a 12-week course of BCBT), 6-month follow-up, 12-month follow-up)
- Brief Symptom Inventory: Psychiatric Symptoms(Baseline, endpoint (end of 12-week BCBT course), 6-month follow-up, and 12 month follow up)