Combined TMS and Brief Cognitive Behavioral Therapy to Reduce Suicide

  • STATUS
    Recruiting
  • End date
    Mar 31, 2023
  • participants needed
    130
  • sponsor
    VA Office of Research and Development
Updated on 1 March 2021
behavior therapy

Summary

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.

Description

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.

Details
Condition Suicide
Treatment transcranial magnetic stimulation, Brief Cognitive Behavioral Therapy
Clinical Study IdentifierNCT03952468
SponsorVA Office of Research and Development
Last Modified on1 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Do you have Suicide??
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

Exclusion Criteria

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
Stroke
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
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