Combined TMS and Brief Cognitive Behavioral Therapy to Reduce Suicide
Completed · Not applicable · Has a placebo group
Conditions studied: Suicide
In brief
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.
Key facts
- Study ID
- NCT03952468
- Run by
- VA Office of Research and Development
- People needed
- 55
- Starts
- 2019-11-04
- Expected to finish
- 2024-04-30
- Last updated by the study team
- 2025-09-09
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Providence VA Medical Center, Providence, RI — Providence, Rhode Island, United States
Full record on ClinicalTrials.gov
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