Combined TMS and Brief Cognitive Behavioral Therapy to Reduce Suicide
Combined Transcranial Magnetic Stimulation and Brief Cognitive Therapy to Reduce Suicide Behavior in High-Risk Veterans
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02908-4734
- Providence VA Medical Center, Providence, RI
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: TMS + Brief Cognitive Behavioral Therapy
Combined transcranial magnetic stimulation and brief cognitive behavioral therapy for suicide
|
Administration of rapidly fluctuating magnetic field, delivered over the dorsolateral prefrontal cortex.
Other Names:
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 Comparator: Sham TMS + Brief cognitive behavioral therapy
Sham Transcranial magnetic stimulation and brief cognitive behavioral therapy for suicide
|
Administration of rapidly fluctuating magnetic field, delivered over the dorsolateral prefrontal cortex.
Other Names:
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Columbia Suicide Severity Rating Scale (CSSRS) (Suicide Composite)
Time Frame: Baseline, endpoint (end of 12-week BCBT course), 6-month follow-up, and 12 month follow up
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Beck Scale for Suicide Ideation (BSSI)
Time Frame: Baseline, endpoint (end of 12-week BCBT course), 6-month follow-up, and 12 month follow up
|
The BSSI is a 21-item measure designed to assess the severity of suicidal thoughts in the week prior to evaluation. The first 5 items are screeners (wish to live, wish to die, and desire to attempt suicide), followed by 14 items to assess suicidal risk factors. The last 2 items capture previous suicide attempts. Each item is scored based on an ordinal scale from 0-2 and the total score range is 0-38 with higher scores indicating greater severity. The SSI total score is obtained by adding up the ratings (0-2) from the first 19 items. |
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
Time Frame: Endpoint (end of 12-week BCBT course), 6-month follow-up, and 12 month follow up
|
The Longitudinal Interval Follow-up Evaluation (LIFE) is a timeline follow up interview measure that is administered at each of the assessment period.
Participants are asked to describe their weekly suicidal thoughts and interviewers rate them on a 6-point Likert score ranging from 1 (not at all) to 6 (Extreme: has made preparations for a potentially serious suicide attempt).
Data is then converted into the presence/absence of suicidal thoughts for each week of the follow up period.
Data reported includes the mean number of weeks with reported suicidal thoughts (scores above 2).
|
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)
Time Frame: Baseline, endpoint (end of 12-week BCBT course), 6-month follow-up, and 12 month follow up
|
The WHODAS 2.0 is a 36-question, self-administered questionnaire and generic assessment instrument for health and disability that covers six domains: Cognition (items 3 and 6), Mobility (items 1 and 7), Self-care (items 8 and 9), Getting Along (items 10 and 11), Life Activities (items 2 and 12), and Participation (items 4 and 5).
Items are rated from "None," "Mild," "Moderate," "Severe," to "Extreme or cannot do," indicating difficulty over the past month.
Total score is calculated by summing the item scores and then converted into a standardized score ranging from 0-100 with higher scores indicating greater disability.
|
Baseline, endpoint (end of 12-week BCBT course), 6-month follow-up, and 12 month follow up
|
|
Treatment History Interview THI: Emergency Services
Time Frame: Endpoint (following a 12-week course of BCBT), 6-month follow-up, 12-month follow-up
|
The THI is an interview used to collect information about psychotherapy, hospitalizations, medical treatment, pharmacotherapy, and other means of psychologically-related help that a person may use.
For this study we assessed the use of emergency services (emergency room visits for psychiatric reasons and hospitalizations for psychiatric reasons).
Outcome was the number of times a participant used either emergency department or was hospitalized for mental health reasons.
|
Endpoint (following a 12-week course of BCBT), 6-month follow-up, 12-month follow-up
|
|
Brief Symptom Inventory: Psychiatric Symptoms
Time Frame: Baseline, endpoint (end of 12-week BCBT course), 6-month follow-up, and 12 month follow up
|
The BSI is a 53-item self-report questionnaire developed by Derogatis and Melisarotos to measure psychological distress and assess the severity of symptom across the following dimensions: Somatization, Obsession-compulsion, interpersonal sensitivity , depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism.
Items are rated on a 5-point Likert scale from 0-4.
The Global severity index (GSI) was used and reported.
GSI is a mean score for all items across all dimensions.
Higher scores are indicative of greater psychological distress.
|
Baseline, endpoint (end of 12-week BCBT course), 6-month follow-up, and 12 month follow up
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jennifer M Primack, PhD MA, Providence VA Medical Center, Providence, RI
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIR 17-201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.