Combined TMS and Brief Cognitive Behavioral Therapy to Reduce Suicide

  • End date
    Mar 31, 2023
  • participants needed
  • sponsor
    VA Office of Research and Development
Updated on 12 March 2022
behavior therapy


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.


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.

Condition Suicide
Treatment transcranial magnetic stimulation, Brief Cognitive Behavioral Therapy
Clinical Study IdentifierNCT03952468
SponsorVA Office of Research and Development
Last Modified on12 March 2022


Yes No Not Sure

Inclusion Criteria

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
Cardiac pacemaker
Cognitive impairment which would interfere with adequate participation in the project
(MMSE < 20)
TMS-specific exclusions are
For safety, participants must meet established screening criteria safety during MRI
pregnancy/lactation, or planning to become pregnant during the study
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
lifetime history of moderate or severe traumatic brain injury (TBI)
from the stimulation coil. These measures require a patient not having the following
Current unstable medical conditions
(unless MRI-safe)
Current (or past if appropriate) significant neurological disorder
Lifetime history seizure disorder
Primary or secondary CNS tumors
Implanted device (deep brain stimulation) or metal in the brain, cervical spinal
cord, or upper thoracic spinal cord
Cerebral aneurysm
Inability to participate in CBT
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
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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact



Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note