Post Traumatic Stress Disorder study: Active rTMS vs Cognitive Processing Therapy
Official title Multi-site Confirmatory Efficacy Treatment Trial of Combat-related PTSD
ClinicalTrials.gov ID: NCT03932773
What this study is testing
- What it's testing
- This study is testing whether combining brain stimulation and talk therapy helps with PTSD. It also looks at changes in mood and brain activity.
- Who it's for
- You may be able to join if you are a veteran with combat-related PTSD.
- What's involved
- You would get brain stimulation and talk therapy. You would also have brain scans and mood checks.
- Time commitment
- The source text does not say how long the study lasts or how many visits are needed.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- Veterans of Post-9/11 military conflicts
- with diagnosis of PTSD based on CAPS-5 related to Post-9/11 military combat
You likely can't join if
- current enrollment in an acute experimental treatment for PTSD or trauma-focused psychotherapy treatment
- PTSD-inducing trauma exposure occurring within the last 3 months prior to pre-enrollment evaluation
- history of epilepsy or seizure disorder, a history of major head trauma,
- any neurologic condition likely to increase risk of seizures,
- brain tumors,
- moderate to severe substance use disorder in last 3 months or any substance use that puts the participant at increased risk or significant impairment
See the full eligibility criteria
- Veterans of Post-9/11 military conflicts
- with diagnosis of PTSD based on CAPS-5 related to Post-9/11 military combat
- current enrollment in an acute experimental treatment for PTSD or trauma-focused psychotherapy treatment
- PTSD-inducing trauma exposure occurring within the last 3 months prior to pre-enrollment evaluation
- history of epilepsy or seizure disorder, a history of major head trauma,
- any neurologic condition likely to increase risk of seizures,
- brain tumors,
- moderate to severe substance use disorder in last 3 months or any substance use that puts the participant at increased risk or significant impairment
- stroke, and blood vessel abnormalities in the brain,
- dementia,
- Parkinson's disease, Huntington's chorea, or multiple sclerosis
- a high suicide risk
- a lifetime history of psychotic disorder or bipolar disorder
- inability to stop taking any medication that significantly lowers the seizure threshold
- pregnant or nursing
- metal fragments in the head, or any metal objects in or near the head that cannot be safely removed
- We will screen for a history of traumatic brain injury and exclude potential participants from the study if they have a history of severe TBI or are at high risk for seizures.
- history of seizures
- non-English speakers because not all of the screening forms, questionnaires, and tests are available in any language except for English
- cardiac pacemaker, implanted medication pumps of any sort that would increase the risk of rTMS
- any current medical condition that could preclude being able to safely participate in TMS treatment,
- use of prescription medication or illegal substances that lower the seizure threshold
- previous rTMS
The study team makes the final eligibility decision.
Where it is enrolling
- Tallahassee, Florida, United States
- Addison, Texas, United States
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Tallahassee, Florida, United States; Addison, Texas, United States; Dallas, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.