New treatment option for PTSD
Official title The Influence of Aerobic Exercise on Consolidation of Fear Extinction Learning in PTSD
ClinicalTrials.gov ID: NCT06144203
What this study is testing
- What it's testing
- This study aims to test whether aerobic exercise performed after fear extinction learning improves cognitive, physiological, and neural indices of extinction recall in a sample of trauma-exposed men and women with and without posttraumatic stress disorder (PTSD). Participants will complete a clinical intake visit (Day 0), followed by a three-day fear conditioning (day 1), fear extinction + activity (day 2), and fear extinction recall (day 3) protocol.
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 64. Healthy volunteers may be eligible.
You may be able to join if
- for PTSD:
- male or female sex
- right-handed
- age 18-64
- a current diagnosis of PTSD where the index event involves interpersonal violence exposure (e.g., physical/sexual assault). for the trauma-exposed...
You likely can't join if
- for all participants:
- current substance use disorder (other than alcohol, nicotine, or cannabis)
- acute suicidality
- history of bipolar/psychotic disorder
- changes to or addition of psychiatric medication in the past 4 weeks (6 weeks for fluoxetine)
- medications that effect neurovascular properties upon which BOLD fMRI capitalizes (e.g., water pills)
See the full eligibility criteria
- for PTSD:
- male or female sex
- right-handed
- age 18-64
- a current diagnosis of PTSD where the index event involves interpersonal violence exposure (e.g., physical/sexual assault). for the trauma-exposed (without PTSD) control participants includes:
- male or female sex
- right-handed
- age 18-64
- interpersonal violence exposure (e.g., physical/sexual assault).
- for all participants:
- current substance use disorder (other than alcohol, nicotine, or cannabis)
- acute suicidality
- history of bipolar/psychotic disorder
- changes to or addition of psychiatric medication in the past 4 weeks (6 weeks for fluoxetine)
- medications that effect neurovascular properties upon which BOLD fMRI capitalizes (e.g., water pills)
- history of neurological disorders or disease (e.g., traumatic brain injury, epilepsy, seizures)
- loss of consciousness \> 10 minutes
- intellectual disabilities (IQ\<70)
- developmental disorders
- MRI contraindication (e.g., internal ferromagnetic objects such as electronic devices, surgical implants, shrapnel; see phone screen)
- claustrophobia or the inability to lie still in a confined space
- physical disabilities that prohibit task performance (e.g., blindness or deafness)
- positive pregnancy test
- cochlear implant
- an implanted neurostimulator
- physical disabilities that prohibit task performance (e.g., blindness or deafness)
- vulnerable populations (i.e., pregnant women, individuals appearing to lack consent capacity, prisoners, individuals unable to read consent materials, individuals in a relationship with study researchers (e.g., friends...
- having a history of chest pain during physical activity
- having a bone, joint, cardiac, or other medical condition that a doctor has said may be worsened by physical activity
- having asthma
- responding 'Yes' to any of the seven questions on the Physical Activity Readiness Questionnaire (PAR-Q - administered as part of the Exercise Safety Questions of the phone screen), indicating it is unsafe for the...
- Percutaneous Coronary Intervention or acute myocardial infarction in the last 6 weeks
- unstable arrhythmias/implanted cardiac defibrillator shocks in the last 3 months
- any other condition that the PI believes might put the participant at risk.
- Additionally, due to their effects on image quality, interested individuals with the following may be ineligible to participate per PI's judgement: nonremovable dental implants (e.g., braces or upper permanent...
The study team makes the final eligibility decision.
Where it's taking place
- Tuscaloosa, Alabama, 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 all sexes, 18 years to 64 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tuscaloosa, Alabama, 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.