BridgeMD
New treatment option for Post Traumatic Stress Disorder
Official title Sleep and Emotion Processing in Adolescent Post-traumatic Stress Disorder
ClinicalTrials.gov ID: NCT06341413
What this study is testing
- What it's testing
- The goal of this clinical trial is to characterize the role of sleep, emotion processing, and daily affect in post-traumatic stress disorder (PTSD) and whether improving sleep quality using slow wave activity enhancement will impact next-day affect in youth. Participants will attend 4 study visits: A clinical and trauma assessment visit A testing day that may include cognitive testing, surveys, and an MRI.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 to 18. Healthy volunteers may be eligible.
You may be able to join if
- All participants must meet all of the following criteria:
- Aged 14-18 years old, inclusive
- Must agree to inform the investigators within 48 hours of any emergent medical conditions and procedures
- Able to lie still on their back for up to 1 hour
- Must not be pregnant
You likely can't join if
- Caregiver or adolescent is unwilling or unable to give adequate informed consent.
- Are likely, in the investigator's opinion and via observation during the screening and clinical assessment period, to be re-exposed to their index...
- Any finding(s), based on the screening process, that the PI feels would make the study unsuitable for the participant.
- Participation in the last 30 days in a clinical study involving an investigational drug
- MRI contraindication
- Claustrophobia or inability lie still in the scanner after practice MRI sessions.
See the full eligibility criteria
- All participants must meet all of the following criteria:
- Aged 14-18 years old, inclusive
- Must agree to inform the investigators within 48 hours of any emergent medical conditions and procedures
- Able to lie still on their back for up to 1 hour
- Must not be pregnant
- Must agree not to participate in any other treatment clinical trials during the duration of the study
- Must be willing to comply with all study procedures
- Agree to have study visits video and/or audio recorded, including consent visit, clinical assessments (for staff training) and in-laboratory sleep visits (recording deleted within one month of study visit).
- A primary parent or guardian is willing participate in the study and to provide informed consent
- Are fluent in or predominantly speaking and reading in English In addition, PTSD and TEC youth must satisfy the following criteria: \- Must have a history of at least one traumatic event of any type, as defined by the...
- Caregiver or adolescent is unwilling or unable to give adequate informed consent.
- Are likely, in the investigator's opinion and via observation during the screening and clinical assessment period, to be re-exposed to their index trauma or other significant trauma, lack social support, or lack a...
- Any finding(s), based on the screening process, that the PI feels would make the study unsuitable for the participant.
- Participation in the last 30 days in a clinical study involving an investigational drug
- MRI contraindication
- Claustrophobia or inability lie still in the scanner after practice MRI sessions.
- Any participant presenting current serious suicide risk, as determined through the KSADS, responses to C-SSRS, and/or clinical judgment of the investigator, will be excluded; however, history of suicide attempts is not...
- Neurodevelopmental disorders such as autism spectrum disorder
- Intellectual Disability (IQ less than 70, per self-report)
- Currently impaired by any medical condition that would prevent study participation
- Traumatic brain injury with ongoing symptoms, including headache, visual disturbances, and/or impairments in concentration.
- Neurological disorder(s) such as seizures, epilepsy, or brain tumors (Tourette's disorder, as diagnosed in the KSADS, is not exclusionary for TEC/PTSD youth)
- Current use of medications or other drugs (i.e., alcohol) in a manner that may interfere with sleep.
- Possible pregnancy Exclusions for Typically developing youth:
- No history of or current psychopathology, as defined in the Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS), with exception of past specific phobia and past, resolved episodes of depressive or anxiety...
- The episode is not current (i.e. does not meet current criteria as assessed by the KSADS),
- The participant is not currently receiving psychiatric treatment (medication or psychotherapy) for mood/anxiety, and
- There is no current serious suicide risk (per KSADS/C-SSRS).
- Current diagnosis of a sleep disorder (self-report).
- Any history of any traumatic experience as defined by the DSM-V, including IPV exposure, neglect, or emotional abuse etc. PTSD Youth: \- Current diagnosis of or history of psychotic disorder, bipolar disorder, or autism...
The study team makes the final eligibility decision.
Where it's taking place
- Madison, Wisconsin, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 14 years to 18 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Madison, Wisconsin, 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.