N/A
N=33
Combined TMS and Brief Cognitive Behavioral Therapy to Reduce Suicide
Suicide
Bottom Line
View on ClinicalTrials.gov: NCT03952468 ↗Enrolled (actual)
33
Serious AEs
33.3%
Results posted
Sep 2025
Primary outcome: Primary: Columbia Suicide Severity Rating Scale (CSSRS) (Suicide Composite) — 0.61; 0.33; 0; 0.17 total number of suicide behaviors
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transcranial Magnetic Stimulation (Device); Brief Cognitive Behavioral Therapy (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Columbia Suicide Severity Rating Scale (CSSRS) (Suicide Composite) |
0.61; 0.33; 0; 0.17; 0.08; 0.18 | — |
| SECONDARY Beck Scale for Suicide Ideation (BSSI) |
15.83; 16.13; 5.14; 7.00; 5.17; 5.82 | — |
| SECONDARY The Longitudinal Interval Follow-up Evaluation (LIFE): Psychiatric Status Rating Scale for Suicidal Ideation |
9.21; 11.58; 5.92; 7.73; 11.00; 13.13 | — |
| SECONDARY Change in World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) |
50.89; 48.20; 35.36; 47.75; 34.92; 37.82 | — |
| SECONDARY Treatment History Interview THI: Emergency Services |
0.14; 0.00; 0.08; 0.18; 0.42; 0.13 | — |
| SECONDARY Brief Symptom Inventory: Psychiatric Symptoms |
2.10; 1.85; 1.10; 1.47; 1.30; 1.27 | — |
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.
Eligibility Criteria
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
- 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
Data sourced from ClinicalTrials.gov (NCT03952468). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.