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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TMS + Brief Cognitive Behavioral Therapy | Active Comparator | Combined transcranial magnetic stimulation and brief cognitive behavioral therapy for suicide |
|
| Sham TMS + Brief cognitive behavioral therapy | Sham Comparator | Sham Transcranial magnetic stimulation and brief cognitive behavioral therapy for suicide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Magnetic Stimulation | Device | Administration of rapidly fluctuating magnetic field, delivered over the dorsolateral prefrontal cortex. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Beck Scale for Suicide Ideation (BSSI) | 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. |
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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):
TMS-specific exclusions are:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer M Primack, PhD MA | Providence VA Medical Center, Providence, RI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence VA Medical Center, Providence, RI | Providence | Rhode Island | 02908-4734 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32251917 | Result | 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. | |
| 33820628 | 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. |
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Following enrollment, 22 Veterans were not randomized. Of these 22 Veterans, 7 were ineligible, 6 were lost to contact, and 9 requested to withdraw participation due to starting residential treatment or work/scheduling concerns.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active TMS + Brief Cognitive Behavioral Therapy | Combined transcranial magnetic stimulation and brief cognitive behavioral therapy for suicide Transcranial Magnetic Stimulation: Administration of rapidly fluctuating magnetic field, delivered over the dorsolateral prefrontal cortex. Brief Cognitive Behavioral Therapy: 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. |
| FG001 | Sham TMS + Brief Cognitive Behavioral Therapy | Sham Transcranial magnetic stimulation and brief cognitive behavioral therapy for suicide Transcranial Magnetic Stimulation: Administration of rapidly fluctuating magnetic field, delivered over the dorsolateral prefrontal cortex. Brief Cognitive Behavioral Therapy: 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Active TMS + Brief Cognitive Behavioral Therapy | Combined transcranial magnetic stimulation and brief cognitive behavioral therapy for suicide Transcranial Magnetic Stimulation: Administration of rapidly fluctuating magnetic field, delivered over the dorsolateral prefrontal cortex. Brief Cognitive Behavioral Therapy: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Demographics self-report. Text box |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Due to study attrition, the number of participants at follow-up differs from the number of participants at baseline. See participant flow for more details. | Posted | Mean | Standard Deviation | total number of suicide behaviors | Baseline, endpoint (end of 12-week BCBT course), 6-month follow-up, and 12 month follow up |
Up to one year.
Adverse events as defined in our study were identical to clinicaltrials.gov definitions.
Adverse events were collected in several ways: 1) events spontaneously reported by participants, 2) review of medical records preceding each follow up period, 3) systematically assessed through a side effects questionnaire that was administered before and after each TMS or sham TMS session, and 4) systematically assessed through the Treatment History Questionnaire.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TMS + Brief Cognitive Behavioral Therapy | Combined transcranial magnetic stimulation and brief cognitive behavioral therapy for suicide Transcranial Magnetic Stimulation: Administration of rapidly fluctuating magnetic field, delivered over the dorsolateral prefrontal cortex. Brief Cognitive Behavioral Therapy: 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psychiatric rehospitalization | Psychiatric disorders | Systematic Assessment | Psychiatric rehospitalization due to suicide ideation or behaviors |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headaches | General disorders | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jennifer Primack | VA Providence Health Care system | (401) 273-7100 | 16295 | Jennifer.Primack@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 23, 2022 | Apr 29, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 13, 2024 | Jul 31, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D013405 | Suicide |
| D000092864 | Suicide Prevention |
| ID | Term |
|---|---|
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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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.
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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.
|
| 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. |
|
| 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 | 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) | 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 | 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 | 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 |
| 35464651 | 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. |
| 33183345 | Derived | 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. |
| Physician Decision |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| BG001 | Sham TMS + Brief Cognitive Behavioral Therapy | Sham Transcranial magnetic stimulation and brief cognitive behavioral therapy for suicide Transcranial Magnetic Stimulation: Administration of rapidly fluctuating magnetic field, delivered over the dorsolateral prefrontal cortex. Brief Cognitive Behavioral Therapy: 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. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| CSSRS ideation severity, past two weeks | Columbia Suicide Severity Rating Scale, ideation subscale for past two weeks. Scores range from 0-5 with higher scores representing more severe ideation. | Mean | Standard Deviation | units on a scale (0-5) |
|
| CSSRS past two week attempts | Past two weeks number of reported suicide attempts collected via interview using the CSSRS suicide attempt item. | Mean | Standard Deviation | number of attempts |
|
| CSSRS past two week behavior composite | Past two week report on CSSRS interview. Count of number of suicide attempts, aborted attempts, and interrupted attempts. | Mean | Standard Deviation | number of suicide behaviors |
|
| CSSRS ideation severity, lifetime | Columbia Suicide Severity rating scale - Ideation subscale interview for lifetime most severe ideation on a scale of 0-5 with higher scores representing more severe ideation type. | Mean | Standard Deviation | units of a scale |
|
| CSSRS (Lifetime number of attempts) | Mean | Standard Deviation | number of attempts |
|
| CSSRS lifetime total number of suicide behaviors composite | Total lifetime number of interrupted, aborted, and actual attempts reported on the CSSRS interview. | Mean | Standard Deviation | number of behaviors |
|
| Beck Hopelessness Scale (BHS) | THE BHS is a 20-item self-report measure designed to measure three major aspects of hopelessness: feelings about the future, loss of motivation, and expectation. Items are rated as true/false with true responses scored as 1 point. Scoring ranges from 0-20 with the following scale 0-3: normal, 4-8: mild hopelessness, 9-14: moderate hopelessness, and 15-20: severe hopelessness. Total scores were used for this study with higher scores indicative of greater hopelessness. | Mean | Standard Deviation | units on a scale |
|
| Brief Symptom Inventory (BSI): Psychiatric Symptoms | 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. | Mean | Standard Deviation | Mean score (GSI) |
|
| PTSD Checklist | The PCL-5 is a 20-item self report measure that assesses the DSM-5 symptoms of PTSD on a 5-point Likert scale (0-4). Total symptom severity score is obtained by summing the scores for all 20 items (0-80). Higher scores are indicative of greater severity. | Mean | Standard Deviation | units on a scale |
|
| Inventory of Depressive Symptomatology-Self Report (IDS-SR) | The IDS-SR is a 30-item self report measure designed to assess the severity of depressive symptom over the last week. Items are scored using a 4-point Likert scale ranging from 0-3 with higher scores indicating greater severity. Total scores are calculated by summing responses to 28 items to obtain a total score ranging from 0-84. | Mean | Standard Deviation | units on a scale |
|
| AUDIT-10 (Alcohol Use Disorders Identification Test) | The AUDIT is a 10-item screening tool developed by the World Health organization to assess alcohol consumption, behaviors, and problems associated with alcohol use. Individual items are rated on a 5-point Likert scale ranging from 0-4 with higher scores indicating more severe use. Range of possible scores is 0-40 with higher scores indicating more severe alcohol use/behaviors. | Mean | Standard Deviation | units on a scale |
|
| DUDIT (Drug Use Disorders Identification Test) | the DUDIT is an 11-item self report measure used to assess drug use and behaviors. Items 1-9 are scored on a 0-4 Likert scale and items 10-11 are scored 0, 2, 4. Total scores are the summation of all items and range from 0-44 with higher scores indicating greater severity of drug-use-related problems. | Mean | Standard Deviation | units on a scale |
|
| World Health Organization Disability Assessment Schedule (WHODAS-2.0) | The WHO-DAS 2.0 36-self-version is a 36-item measure that assesses disability across six domains of functioning (cognition, mobility, self-care, getting along, life activities, and participation) in adults. Each item is rated on a 5-point likert scale from 0-4 with higher scores indicating greater disability. 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. | Mean | Standard Deviation | standardized scores |
|
| Beck Scale for suicide ideation (BSSI) | The BSSI is a 19-item measure designed to assess the severity of suicidal thoughts in the week prior to evaluation. 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. | Mean | Standard Deviation | units on a scale |
|
| McLean Borderline Personality screen (MSI-BPD) | The MSI-BPD is a 10-item self-report tool designed to screen for Borderline Personality. Each item is rating on a dichotomous scale (1 for present, 0 for absent) and the total score ranges from 9-10 with higher scores indicative of greater likelihood for the presence of BPD. In this study, count is reported for the number of participants who scored >= 7 (the cutoff indicating presence of BPD symptoms). | Count of Participants | Participants |
|
| SCID Module A | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | TMS + Brief Cognitive Behavioral Therapy | Combined transcranial magnetic stimulation and brief cognitive behavioral therapy for suicide Transcranial Magnetic Stimulation: Administration of rapidly fluctuating magnetic field, delivered over the dorsolateral prefrontal cortex. Brief Cognitive Behavioral Therapy: 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. |
| OG001 | Sham TMS + Brief Cognitive Behavioral Therapy | Sham Transcranial magnetic stimulation and brief cognitive behavioral therapy for suicide Transcranial Magnetic Stimulation: Administration of rapidly fluctuating magnetic field, delivered over the dorsolateral prefrontal cortex. Brief Cognitive Behavioral Therapy: 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. |
|
|
| Secondary | Beck Scale for Suicide Ideation (BSSI) | 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. | Due to study attrition, the number of participants at follow-up differs from the number of participants at baseline. See participant flow for more details. | Posted | Mean | Standard Deviation | units on a scale | Baseline, endpoint (end of 12-week BCBT course), 6-month follow-up, and 12 month follow up |
|
|
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| Secondary | The Longitudinal Interval Follow-up Evaluation (LIFE): Psychiatric Status Rating Scale for Suicidal Ideation | 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). | Due to study attrition, the number of participants at follow-up differs from the number of participants at baseline. See participant flow for more details. | Posted | Mean | Standard Deviation | number of weeks with suicidal ideation | Endpoint (end of 12-week BCBT course), 6-month follow-up, and 12 month follow up |
|
|
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| Secondary | Change in World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) | 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. | Due to study attrition, the number of participants at follow-up differs from the number of participants at baseline. See participant flow for more details. | Posted | Mean | Standard Deviation | score on a scale | Baseline, endpoint (end of 12-week BCBT course), 6-month follow-up, and 12 month follow up |
|
|
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| Secondary | Treatment History Interview THI: Emergency Services | 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. | Due to study attrition, the number of participants at follow-up differs from the number of participants at baseline. See participant flow for more details. | Posted | Mean | Standard Deviation | number of times used emergency services | Endpoint (following a 12-week course of BCBT), 6-month follow-up, 12-month follow-up |
|
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| Secondary | Brief Symptom Inventory: Psychiatric Symptoms | 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. | Due to study attrition, the number of participants at follow-up differs from the number of participants at baseline. See participant flow for more details. | Posted | Mean | Standard Deviation | Mean score (GSI) | Baseline, endpoint (end of 12-week BCBT course), 6-month follow-up, and 12 month follow up |
|
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| 0 |
| 18 |
| 6 |
| 18 |
| 11 |
| 18 |
| EG001 | Sham TMS + Brief Cognitive Behavioral Therapy | Sham Transcranial magnetic stimulation and brief cognitive behavioral therapy for suicide Sham Transcranial Magnetic Stimulation Brief Cognitive Behavioral Therapy: 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. | 1 | 15 | 5 | 15 | 6 | 15 |
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| Medical hospitalization | Surgical and medical procedures | Systematic Assessment | Hospitalization due to surgery or other medical procedures |
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| Psychiatric hospitalization due to worsening mental health symptoms | Psychiatric disorders | Systematic Assessment | Psychiatric admission due to mental health symptoms (not SI/SB) |
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| Medical hospitalization | Vascular disorders | Systematic Assessment |
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| Medical hospitalization | General disorders | Systematic Assessment |
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| ER visit for psychiatric reasons | Psychiatric disorders | Systematic Assessment | Visit to ER for psychiatric symptoms other than SI/SB |
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| Treatment site discomfort | General disorders | Systematic Assessment |
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| Endpoint (~12 weeks) |
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| 6-Month Follow-Up |
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| 12-Month Follow-Up |
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| 6-Month Follow-Up |
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| 12-Month Follow-Up |
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| Endpoint |
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| 6-Month Follow-Up |
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| 12-Month Follow-Up |
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| 6-Month Follow-Up |
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| 12-Month Follow-Up |
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| Endpoint (12-weeks) |
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| 6-Month Follow-Up |
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| 12-Month Follow-Up |
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