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New treatment option for PTSD - Post Traumatic Stress Disorder
Official title The New Empowerment After eXposure to Trauma (NEXT) Study
ClinicalTrials.gov ID: NCT07175025
What this study is testing
- What it's testing
- The NEXT Study is a randomized controlled pilot examining the feasibility and acceptability of a revised perinatal PTSD protocol. This study will randomize perinatal participants with PTSD to receive NET (n=45); treatment group) and will be compared to perinatal women randomized to usual care (n=45; comparator group).
- Which group you join is decided by chance.
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 50, women only
You may be able to join if
- 18 years of age or older
- able to read and speak English
- diagnosis of probable PTSD as determined by the PTSD Checklist for DSM-5 (PCL-5)
- pregnant or postpartum (delivered within 12 weeks) at the time of the eligibility screen
You likely can't join if
- current severe suicide risk as determined by the Columbia Suicide Severity Rating Scale Screener (C-SSRS)
- current psychotic or manic symptoms as determined by the DIAMOND screener and the Mood Disorder Questionnaire for Bipolar Disorder
- cognitive impairment
- concurrent trauma-focused psychotherapy
- medical advice limiting participation in exposure therapy
- current legal actions related to trauma
See the full eligibility criteria
- 18 years of age or older
- able to read and speak English
- diagnosis of probable PTSD as determined by the PTSD Checklist for DSM-5 (PCL-5)
- pregnant or postpartum (delivered within 12 weeks) at the time of the eligibility screen
- current severe suicide risk as determined by the Columbia Suicide Severity Rating Scale Screener (C-SSRS)
- current psychotic or manic symptoms as determined by the DIAMOND screener and the Mood Disorder Questionnaire for Bipolar Disorder
- cognitive impairment
- concurrent trauma-focused psychotherapy
- medical advice limiting participation in exposure therapy
- current legal actions related to trauma
- does not meet criteria for PTSD
- not pregnant or delivered more than 12 weeks after timing of eligibility screening
The study team makes the final eligibility decision.
Where it's taking place
- Indianapolis, Indiana, 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 - 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 female, 18 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Indianapolis, Indiana, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.