Trial Outcomes & Findings for Combined TMS and Brief Cognitive Behavioral Therapy to Reduce Suicide (NCT NCT03952468)
NCT ID: NCT03952468
Last Updated: 2025-09-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
55 participants
Primary outcome timeframe
Baseline, endpoint (end of 12-week BCBT course), 6-month follow-up, and 12 month follow up
Results posted on
2025-09-09
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
15
|
|
Overall Study
Completed TMS+BCBT Phase
|
15
|
12
|
|
Overall Study
Completed BCBT-Only and Endpoint Assessments
|
14
|
12
|
|
Overall Study
Completed 6-month Follow-up
|
12
|
11
|
|
Overall Study
Completed 12-month Follow-up
|
12
|
8
|
|
Overall Study
COMPLETED
|
12
|
8
|
|
Overall Study
NOT COMPLETED
|
6
|
7
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
Combined TMS and Brief Cognitive Behavioral Therapy to Reduce Suicide
Baseline characteristics by cohort
| Measure |
Active TMS + Brief Cognitive Behavioral Therapy
n=18 Participants
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.
|
Sham TMS + Brief Cognitive Behavioral Therapy
n=15 Participants
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.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.8 Years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
50.4 Years
STANDARD_DEVIATION 13.6 • n=7 Participants
|
49.0 Years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
CSSRS ideation severity, past two weeks
|
4.56 units on a scale (0-5)
STANDARD_DEVIATION 0.51 • n=5 Participants
|
4.33 units on a scale (0-5)
STANDARD_DEVIATION 0.62 • n=7 Participants
|
4.45 units on a scale (0-5)
STANDARD_DEVIATION 0.56 • n=5 Participants
|
|
CSSRS past two week attempts
|
0.39 number of attempts
STANDARD_DEVIATION 0.70 • n=5 Participants
|
0.27 number of attempts
STANDARD_DEVIATION 0.80 • n=7 Participants
|
0.33 number of attempts
STANDARD_DEVIATION 0.74 • n=5 Participants
|
|
CSSRS past two week behavior composite
|
0.61 number of suicide behaviors
STANDARD_DEVIATION 0.92 • n=5 Participants
|
0.33 number of suicide behaviors
STANDARD_DEVIATION 0.82 • n=7 Participants
|
0.48 number of suicide behaviors
STANDARD_DEVIATION 0.87 • n=5 Participants
|
|
CSSRS ideation severity, lifetime
|
4.56 units of a scale
STANDARD_DEVIATION 0.51 • n=5 Participants
|
4.4 units of a scale
STANDARD_DEVIATION 0.51 • n=7 Participants
|
4.48 units of a scale
STANDARD_DEVIATION 0.51 • n=5 Participants
|
|
CSSRS (Lifetime number of attempts)
|
2.78 number of attempts
STANDARD_DEVIATION 5.93 • n=5 Participants
|
5.47 number of attempts
STANDARD_DEVIATION 8.33 • n=7 Participants
|
4.00 number of attempts
STANDARD_DEVIATION 7.13 • n=5 Participants
|
|
CSSRS lifetime total number of suicide behaviors composite
|
2.94 number of behaviors
STANDARD_DEVIATION 5.89 • n=5 Participants
|
6.53 number of behaviors
STANDARD_DEVIATION 9.98 • n=7 Participants
|
4.58 number of behaviors
STANDARD_DEVIATION 8.08 • n=5 Participants
|
|
Beck Hopelessness Scale (BHS)
|
11.5 units on a scale
STANDARD_DEVIATION 6.71 • n=5 Participants
|
11.0 units on a scale
STANDARD_DEVIATION 6.46 • n=7 Participants
|
11.27 units on a scale
STANDARD_DEVIATION 6.50 • n=5 Participants
|
|
Brief Symptom Inventory (BSI): Psychiatric Symptoms
|
2.10 Mean score (GSI)
STANDARD_DEVIATION 1.13 • n=5 Participants
|
1.85 Mean score (GSI)
STANDARD_DEVIATION 1.04 • n=7 Participants
|
1.99 Mean score (GSI)
STANDARD_DEVIATION 1.08 • n=5 Participants
|
|
PTSD Checklist
|
49.11 units on a scale
STANDARD_DEVIATION 20.46 • n=5 Participants
|
43.67 units on a scale
STANDARD_DEVIATION 23.79 • n=7 Participants
|
46.64 units on a scale
STANDARD_DEVIATION 21.86 • n=5 Participants
|
|
Inventory of Depressive Symptomatology-Self Report (IDS-SR)
|
44.0 units on a scale
STANDARD_DEVIATION 17.44 • n=5 Participants
|
39.87 units on a scale
STANDARD_DEVIATION 15.71 • n=7 Participants
|
42.12 units on a scale
STANDARD_DEVIATION 26.80 • n=5 Participants
|
|
AUDIT-10 (Alcohol Use Disorders Identification Test)
|
9.83 units on a scale
STANDARD_DEVIATION 11.98 • n=5 Participants
|
9.47 units on a scale
STANDARD_DEVIATION 11.58 • n=7 Participants
|
9.67 units on a scale
STANDARD_DEVIATION 11.62 • n=5 Participants
|
|
DUDIT (Drug Use Disorders Identification Test)
|
4.67 units on a scale
STANDARD_DEVIATION 6.51 • n=5 Participants
|
2.80 units on a scale
STANDARD_DEVIATION 4.00 • n=7 Participants
|
3.82 units on a scale
STANDARD_DEVIATION 5.51 • n=5 Participants
|
|
World Health Organization Disability Assessment Schedule (WHODAS-2.0)
|
50.89 standardized scores
STANDARD_DEVIATION 30.20 • n=5 Participants
|
48.20 standardized scores
STANDARD_DEVIATION 23.03 • n=7 Participants
|
49.67 standardized scores
STANDARD_DEVIATION 26.20 • n=5 Participants
|
|
Beck Scale for suicide ideation (BSSI)
|
15.83 units on a scale
STANDARD_DEVIATION 8.45 • n=5 Participants
|
16.13 units on a scale
STANDARD_DEVIATION 4.42 • n=7 Participants
|
15.97 units on a scale
STANDARD_DEVIATION 6.82 • n=5 Participants
|
|
McLean Borderline Personality screen (MSI-BPD)
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
SCID Module A
Current Major Depressive Episode
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
SCID Module A
Past Major Depressive Episode
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
SCID Module A
Current Hypomanic Episode
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
SCID Module A
Past Hypomanic Episode
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
SCID Module A
Did not meet diagnostic criteria
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, endpoint (end of 12-week BCBT course), 6-month follow-up, and 12 month follow upPopulation: 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.
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.
Outcome measures
| Measure |
TMS + Brief Cognitive Behavioral Therapy
n=18 Participants
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.
|
Sham TMS + Brief Cognitive Behavioral Therapy
n=15 Participants
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.
|
|---|---|---|
|
Columbia Suicide Severity Rating Scale (CSSRS) (Suicide Composite)
Baseline
|
0.61 total number of suicide behaviors
Standard Deviation 0.92
|
0.33 total number of suicide behaviors
Standard Deviation 0.82
|
|
Columbia Suicide Severity Rating Scale (CSSRS) (Suicide Composite)
Endpoint (~12-weeks)
|
0 total number of suicide behaviors
Standard Deviation 0
|
0.17 total number of suicide behaviors
Standard Deviation 0.39
|
|
Columbia Suicide Severity Rating Scale (CSSRS) (Suicide Composite)
6-Month Follow-Up
|
0.08 total number of suicide behaviors
Standard Deviation 0.29
|
0.18 total number of suicide behaviors
Standard Deviation 0.40
|
|
Columbia Suicide Severity Rating Scale (CSSRS) (Suicide Composite)
12-Month Follow-Up
|
0 total number of suicide behaviors
Standard Deviation 0
|
0 total number of suicide behaviors
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Baseline, endpoint (end of 12-week BCBT course), 6-month follow-up, and 12 month follow upPopulation: 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.
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.
Outcome measures
| Measure |
TMS + Brief Cognitive Behavioral Therapy
n=18 Participants
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.
|
Sham TMS + Brief Cognitive Behavioral Therapy
n=15 Participants
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.
|
|---|---|---|
|
Beck Scale for Suicide Ideation (BSSI)
Baseline
|
15.83 units on a scale
Standard Deviation 8.45
|
16.13 units on a scale
Standard Deviation 4.42
|
|
Beck Scale for Suicide Ideation (BSSI)
Endpoint (~12 weeks)
|
5.14 units on a scale
Standard Deviation 6.71
|
7.00 units on a scale
Standard Deviation 5.24
|
|
Beck Scale for Suicide Ideation (BSSI)
6-Month Follow-Up
|
5.17 units on a scale
Standard Deviation 7.88
|
5.82 units on a scale
Standard Deviation 8.81
|
|
Beck Scale for Suicide Ideation (BSSI)
12-Month Follow-Up
|
4.33 units on a scale
Standard Deviation 4.92
|
6.87 units on a scale
Standard Deviation 6.10
|
SECONDARY outcome
Timeframe: Endpoint (end of 12-week BCBT course), 6-month follow-up, and 12 month follow upPopulation: 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.
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).
Outcome measures
| Measure |
TMS + Brief Cognitive Behavioral Therapy
n=14 Participants
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.
|
Sham TMS + Brief Cognitive Behavioral Therapy
n=12 Participants
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.
|
|---|---|---|
|
The Longitudinal Interval Follow-up Evaluation (LIFE): Psychiatric Status Rating Scale for Suicidal Ideation
Endpoint
|
9.21 number of weeks with suicidal ideation
Standard Deviation 5.92
|
11.58 number of weeks with suicidal ideation
Standard Deviation 7.01
|
|
The Longitudinal Interval Follow-up Evaluation (LIFE): Psychiatric Status Rating Scale for Suicidal Ideation
6-Month Follow-Up
|
5.92 number of weeks with suicidal ideation
Standard Deviation 6.23
|
7.73 number of weeks with suicidal ideation
Standard Deviation 7.48
|
|
The Longitudinal Interval Follow-up Evaluation (LIFE): Psychiatric Status Rating Scale for Suicidal Ideation
12-Month Follow-Up
|
11.00 number of weeks with suicidal ideation
Standard Deviation 11.11
|
13.13 number of weeks with suicidal ideation
Standard Deviation 12.00
|
SECONDARY outcome
Timeframe: Baseline, endpoint (end of 12-week BCBT course), 6-month follow-up, and 12 month follow upPopulation: 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.
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.
Outcome measures
| Measure |
TMS + Brief Cognitive Behavioral Therapy
n=18 Participants
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.
|
Sham TMS + Brief Cognitive Behavioral Therapy
n=15 Participants
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.
|
|---|---|---|
|
Change in World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
Baseline
|
50.89 score on a scale
Standard Deviation 30.20
|
48.20 score on a scale
Standard Deviation 23.03
|
|
Change in World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
Endpoint
|
35.36 score on a scale
Standard Deviation 24.58
|
47.75 score on a scale
Standard Deviation 22.63
|
|
Change in World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
6-Month Follow-Up
|
34.92 score on a scale
Standard Deviation 25.69
|
37.82 score on a scale
Standard Deviation 21.03
|
|
Change in World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
12-Month Follow-Up
|
34.83 score on a scale
Standard Deviation 26.37
|
40.50 score on a scale
Standard Deviation 31.87
|
SECONDARY outcome
Timeframe: Endpoint (following a 12-week course of BCBT), 6-month follow-up, 12-month follow-upPopulation: 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.
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.
Outcome measures
| Measure |
TMS + Brief Cognitive Behavioral Therapy
n=14 Participants
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.
|
Sham TMS + Brief Cognitive Behavioral Therapy
n=12 Participants
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.
|
|---|---|---|
|
Treatment History Interview THI: Emergency Services
Endpoint (12-weeks)
|
0.14 number of times used emergency services
Standard Deviation 0.53
|
0.00 number of times used emergency services
Standard Deviation 0.00
|
|
Treatment History Interview THI: Emergency Services
6-Month Follow-Up
|
0.08 number of times used emergency services
Standard Deviation 0.29
|
0.18 number of times used emergency services
Standard Deviation 0.60
|
|
Treatment History Interview THI: Emergency Services
12-Month Follow-Up
|
0.42 number of times used emergency services
Standard Deviation 0.67
|
0.13 number of times used emergency services
Standard Deviation 0.35
|
SECONDARY outcome
Timeframe: Baseline, endpoint (end of 12-week BCBT course), 6-month follow-up, and 12 month follow upPopulation: 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.
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.
Outcome measures
| Measure |
TMS + Brief Cognitive Behavioral Therapy
n=18 Participants
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.
|
Sham TMS + Brief Cognitive Behavioral Therapy
n=15 Participants
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.
|
|---|---|---|
|
Brief Symptom Inventory: Psychiatric Symptoms
12-Month Follow-Up
|
1.06 Mean score (GSI)
Standard Deviation 0.79
|
1.18 Mean score (GSI)
Standard Deviation 0.98
|
|
Brief Symptom Inventory: Psychiatric Symptoms
Baseline
|
2.10 Mean score (GSI)
Standard Deviation 1.13
|
1.85 Mean score (GSI)
Standard Deviation 1.04
|
|
Brief Symptom Inventory: Psychiatric Symptoms
Endpoint (12-weeks)
|
1.10 Mean score (GSI)
Standard Deviation 0.87
|
1.47 Mean score (GSI)
Standard Deviation 1.07
|
|
Brief Symptom Inventory: Psychiatric Symptoms
6-Month Follow-Up
|
1.30 Mean score (GSI)
Standard Deviation 0.99
|
1.27 Mean score (GSI)
Standard Deviation 0.99
|
Adverse Events
TMS + Brief Cognitive Behavioral Therapy
Serious events: 6 serious events
Other events: 11 other events
Deaths: 0 deaths
Sham TMS + Brief Cognitive Behavioral Therapy
Serious events: 5 serious events
Other events: 6 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
TMS + Brief Cognitive Behavioral Therapy
n=18 participants at risk
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.
|
Sham TMS + Brief Cognitive Behavioral Therapy
n=15 participants at risk
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.
|
|---|---|---|
|
Psychiatric disorders
Psychiatric rehospitalization
|
16.7%
3/18 • Number of events 4 • 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.
|
13.3%
2/15 • Number of events 3 • 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.
|
|
Surgical and medical procedures
Medical hospitalization
|
5.6%
1/18 • Number of events 1 • 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.
|
0.00%
0/15 • 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.
|
|
Psychiatric disorders
Psychiatric hospitalization due to worsening mental health symptoms
|
5.6%
1/18 • Number of events 1 • 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.
|
0.00%
0/15 • 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.
|
|
Vascular disorders
Medical hospitalization
|
0.00%
0/18 • 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.
|
6.7%
1/15 • Number of events 1 • 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.
|
|
General disorders
Medical hospitalization
|
0.00%
0/18 • 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.
|
13.3%
2/15 • Number of events 2 • 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.
|
|
Psychiatric disorders
ER visit for psychiatric reasons
|
5.6%
1/18 • Number of events 1 • 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.
|
0.00%
0/15 • 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.
|
Other adverse events
| Measure |
TMS + Brief Cognitive Behavioral Therapy
n=18 participants at risk
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.
|
Sham TMS + Brief Cognitive Behavioral Therapy
n=15 participants at risk
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.
|
|---|---|---|
|
General disorders
Headaches
|
16.7%
3/18 • Number of events 3 • 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.
|
20.0%
3/15 • Number of events 3 • 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.
|
|
General disorders
Treatment site discomfort
|
55.6%
10/18 • Number of events 10 • 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.
|
20.0%
3/15 • Number of events 3 • 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.
|
Additional Information
Dr. Jennifer Primack
VA Providence Health Care system
Phone: (401) 273-7100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place