Combined TMS and Brief Cognitive Behavioral Therapy to Reduce Suicide

NCT03952468 | Completed Results DMC FDA Device

• 1 other identifier: IIR 17-201
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Suicide

Keywords

suicide prevention; Veterans

Outcome Measures

Primary Outcomes (1)

• Columbia Suicide Severity Rating Scale (CSSRS) (Suicide Composite)

  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.

  Baseline, endpoint (end of 12-week BCBT course), 6-month follow-up, and 12 month follow up

Secondary Outcomes (5)

• 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

Study Arms (2)

TMS + Brief Cognitive Behavioral Therapy

ACTIVE COMPARATOR

Combined transcranial magnetic stimulation and brief cognitive behavioral therapy for suicide

Device: Transcranial Magnetic Stimulation; Other: Brief Cognitive Behavioral Therapy

Sham TMS + Brief cognitive behavioral therapy

SHAM COMPARATOR

Sham Transcranial magnetic stimulation and brief cognitive behavioral therapy for suicide

Device: Transcranial Magnetic Stimulation; Other: Brief Cognitive Behavioral Therapy

Interventions

Transcranial Magnetic Stimulation DEVICE

Administration of rapidly fluctuating magnetic field, delivered over the dorsolateral prefrontal cortex.

Also known as: TMS

Sham TMS + Brief cognitive behavioral therapy; TMS + Brief Cognitive Behavioral Therapy

Brief Cognitive Behavioral Therapy OTHER

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.

Sham TMS + Brief cognitive behavioral therapy; TMS + Brief Cognitive Behavioral Therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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.
• Place Veterans at greater risk of seizures from TMS, such as severe and uncontrolled substance use disorder

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Providence VA Medical Center, Providence, RI

Providence, Rhode Island, 02908-4734, United States

Location

Related Publications (4)

• Bozzay ML, Primack J, Barredo J, Philip NS. Transcranial magnetic stimulation to reduce suicidality - A review and naturalistic outcomes. J Psychiatr Res. 2020 Jun;125:106-112. doi: 10.1016/j.jpsychires.2020.03.016. Epub 2020 Mar 28.

  PMID: 32251917 RESULT

• Barredo J, Bozzay ML, Primack JM, Schatten HT, Armey MF, Carpenter LL, Philip NS. Translating Interventional Neuroscience to Suicide: It's About Time. Biol Psychiatry. 2021 Jun 1;89(11):1073-1083. doi: 10.1016/j.biopsych.2021.01.013. Epub 2021 Feb 1.

  PMID: 33820628 RESULT

• Bozzay ML, Jiang L, Zullo AR, Riester MR, Lafo JA, Kunicki ZJ, Rudolph JL, Madrigal C, Clements R, Erqou S, Wu WC, Correia S, Primack JM. Mortality in patients with heart failure and suicidal ideation discharged to skilled nursing facilities. J Geriatr Cardiol. 2022 Mar 28;19(3):198-208. doi: 10.11909/j.issn.1671-5411.2022.03.009. No abstract available.

  PMID: 35464651 RESULT

• Bozzay ML, Primack JM, Swearingen HR, Barredo J, Philip NS. Combined transcranial magnetic stimulation and brief cognitive behavioral therapy for suicide: study protocol for a randomized controlled trial in veterans. Trials. 2020 Nov 12;21(1):924. doi: 10.1186/s13063-020-04870-6.

  PMID: 33183345 DERIVED

MeSH Terms

Conditions

Suicide; Suicide Prevention

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Limitations and Caveats

The COVID-19 pandemic significantly impacted recruitment and retention particularly as inpatient psychiatric units shifted to house chronically ill patients and discharge planning moved to non-local environments. The requirement for daily stimulation visits for 6-8 weeks also impacted outcomes.

Results Point of Contact

• Title: Dr. Jennifer Primack
• Organization: VA Providence Health Care system

Jennifer.Primack@va.gov

(401) 273-7100

Study Officials

• Jennifer M Primack, PhD MA

  Providence VA Medical Center, Providence, RI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 130 Veterans admitted to the Providence VAMC psychiatric inpatient unit due to suicide attempt or ideation with intent to make an attempt will be recruited and randomly assigned to receive: a) active TMS+BCBT or b) sham TMS+BCBT. Both interventions will begin within the week following hospital discharge, and Veterans will be followed for 12 months post-discharge.

Study Record Dates

• First Submitted: May 3, 2019
• First Posted: May 16, 2019
• Study Start: November 4, 2019
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: September 9, 2025
• Results First Posted: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)