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Behavioural Intervention
TMS + Cognitive Behavioral Therapy for Suicide Risk
N/A
Recruiting
Led By Jennifer Marie Primack, PhD MA
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 month follow up
Awards & highlights
Study Summary
This trial will test whether combining two existing treatments, cognitive behavioral therapy and transcranial magnetic stimulation, can reduce suicide rates among veterans, which have remained unchanged for the past 10 years.
Who is the study for?
This trial is for Veterans who have recently attempted suicide or had the intent to, as confirmed by hospital records and assessments. It's not open to those with significant neurological disorders, bipolar disorder, severe cognitive impairment, metal implants incompatible with MRI, pregnancy/lactation plans during the study period, history of moderate/severe TBI, unstable medical conditions, seizure disorders or primary psychotic disorders.Check my eligibility
What is being tested?
The trial tests a combination of brief cognitive behavioral therapy (BCBT) and repetitive transcranial magnetic stimulation (TMS) in reducing Veteran suicides. These treatments are available at VA Medical Centers but haven't been used together before. The study aims to create an effective treatment protocol.See study design
What are the potential side effects?
Potential side effects from TMS may include discomfort at the stimulation site on the head, headache, lightheadedness or seizures in rare cases. BCBT generally does not cause side effects but discussing distressing topics can sometimes temporarily increase emotional discomfort.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 month follow up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 month follow up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Columbia Suicide Severity Rating Scale (CSSRS)
Secondary outcome measures
Change in Beck Scale for Suicide Ideation (SSI)
Change in Treatment History Questionnaire
Change in World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: TMS + Brief Cognitive Behavioral TherapyActive Control2 Interventions
Combined transcranial magnetic stimulation and brief cognitive behavioral therapy for suicide
Group II: Sham TMS + Brief cognitive behavioral therapyPlacebo Group2 Interventions
Sham Transcranial magnetic stimulation and brief cognitive behavioral therapy for suicide
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,610 Previous Clinical Trials
3,305,054 Total Patients Enrolled
39 Trials studying Suicide
6,416 Patients Enrolled for Suicide
Jennifer Marie Primack, PhD MAPrincipal InvestigatorProvidence VA Medical Center, Providence, RI
1 Previous Clinical Trials
107 Total Patients Enrolled
1 Trials studying Suicide
107 Patients Enrolled for Suicide
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a cerebral aneurysm.I have a device or metal in my brain or upper spine.I cannot participate in cognitive behavioral therapy.You have a mental health condition called a primary psychotic disorder.You have a cardiac pacemaker implanted in your heart.I do not have any unstable medical conditions.You have been diagnosed with bipolar disorder.You have a condition, like bipolar disorder, that could become worse if you receive TMS treatment.You have a history of seizures throughout your life.Veterans with severe and uncontrolled substance use disorder may be more likely to have seizures from the TMS procedure.You have other health conditions or circumstances that, according to the research team, could make it difficult for you to finish the study or affect the accuracy of the results.I meet the safety requirements for an MRI scan.I have had a stroke.You have had a serious head injury in the past.I'm sorry, but it seems that the criterion you provided is incomplete. Could you please provide the full text of the criterion so that I can accurately summarize it for you?I have a brain tumor.I have (or had) a serious brain or nerve condition.
Research Study Groups:
This trial has the following groups:- Group 1: Sham TMS + Brief cognitive behavioral therapy
- Group 2: TMS + Brief Cognitive Behavioral Therapy
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people have volunteered to participate in this clinical trial thus far?
"Yes, the information available on clinicaltrials.gov indicates that this trial is still looking for patients to enroll. This particular study was posted on November 4th, 2019 and updated February 4th, 2020. They are hoping to enroll a total of 130 patients from 1 location."
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