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Lo studio clinico NCT06127342 per PTSD è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
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Exercise and Emotional Learning in Posttraumatic Stress Disorder
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La sperimentazione clinica NCT06127342 è uno studio interventistico per PTSD, attualmente in arruolamento. Avviato il 13 maggio 2024, prevede di arruolare 100 partecipanti. Sotto la guida di Christal L Badour, dovrebbe concludersi entro il 30 novembre 2026. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 3 settembre 2025.
Sommario breve
The goal of this clinical trial is to test how exercise affects learning and memory processes relevant to the treatment of PTSD. Participants will complete a baseline intake followed by two experimental sessions. During the first experimental session, participants will undergo an MRI session of imaginal exposure to traumatic memory cues followed by 30-minutes of moderate intensity exercise or low intensity exercise. Participants will complete a second session of imaginal exposure with MRI 24 hours later.
Descrizione dettagliata
The proposed project would build on our published pilot data and animal models to demonstrate that moderate intensity physical exercise delivered after exposure therapy engages fear circuitry and enhances the consolidation of therapeutic safety learning, thereby enabling enhanced symptom reduction for PTSD. Adults with PTSD related to interpersonal violence (IPV) exposure would complete an initial session of imaginal exposure to traumatic memory cues adapted for an MRI setting. This would be followed by 30-mins of moderate intensity exercise or low intensity exercise control. Participants would return 24-hrs later to complete a second session of imaginal exposure with MRI.
Titolo ufficiale
Exercise and Emotional Learning in Posttraumatic Stress Disorder
Condizioni
PTSDAltri ID dello studio
Numero NCT
Data di inizio (effettiva)
2024-05-13
Ultimo aggiornamento pubblicato
2025-09-03
Data di completamento (stimata)
2026-11-30
Arruolamento (previsto)
100
Tipo di studio
Interventistico
FASE
N.D.
Stato
In arruolamento
Parole chiave
Interpersonal Violence
Exercise
Exercise
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Singolo
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
SperimentaleModerate Intensity Exercise Visit 1: Participants will complete study screening, PTSD assessments, and provide written narrative for a traumatic event and a neutral control event.
Visit 2: Participants will complete baseline structural MRI scans before completing 8 trials of imaginal exposure - 4 neutral then 4 trauma narratives - with psychophysiological and fMRI measurement. Following completion of the imaginal exposure task, the participant will perform Moderate-Intensity Exercise (30-min at 70-75% max HR with 5-min warm-up and 5-min cool-down at 40-50% max HR), on a stationary bike.
Visit 3: Participants will complete the same imaginal exposure with measurement of psychophysiology, fMRI, and subjective emotional responding. | Esercizio a intensità moderata Participants will wear a heartrate monitor and cycle on a stationary bike at a slow speed for 5 minutes, then slowly cycle on a stationary bike for 30 minutes, then cycle on the stationary bike at a slow speed for 5 minutes. |
Comparatore attivoLow Intensity Exercise Visit 1: Participants will complete study screening, PTSD assessments, and provide written narrative for a traumatic event and a neutral control event.
Visit 2: Participants will complete baseline structural MRI scans before completing 8 trials of imaginal exposure - 4 neutral then 4 trauma narratives - with psychophysiological and fMRI measurement. Following completion of the imaginal exposure task, the participant will perform Low-Intensity Exercise (control; 40-mins at 40-50% max HR),on a stationary bike.
Visit 3: Participants will complete the same imaginal exposure with measurement of psychophysiology, fMRI, and subjective emotional responding. | Low Intensity Exercise Participants will wear a heartrate monitor and cycle on a stationary bike at a slow speed for 40 minutes. |
Esito primario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Change in participant subjective emotional ratings | Participant anxiety will be measured at baseline and after each imagery trial using a 10-point Likert-type scale with higher scores indicative of more subjective anxiety. | 24 hours |
Change in Heart Rate | Participant heart rate will be measured at baseline and after each imagery trial using a Biopac MP160 system | 24 hours |
Change in Fear Circuit Blood Oxygen Level-Dependent (BOLD) Response | Blood Oxygen Level-Dependent (BOLD) imaging will be measured during each imagery trial | 48 hours |
Criteri di eleggibilità
Età idonea
Adulto
Età minima
18 Years
Sessi idonei
Tutti
- Adults with PTSD related to interpersonal violence
- Active or recent (within the last 3 months) severe substance use disorder(s)
- Active or recent (within the last 3 months) suicidal, psychotic, or manic symptoms/ episodes
- Significant developmental disabilities
- Current daily benzodiazepine or stimulant use with inability to abstain for study sessions
- Recent changes in psychiatric medication or trauma focused cognitive-behavioral therapy (CBT) (past 4-weeks)
- Medical condition(s) that prohibit exercise
- History of traumatic brain injury (TBI) with loss of consciousness > 30 mins
- Magnetic resonance imaging (MRI) contraindication(s)
- Positive pregnancy test
- History of seizure disorder
- Spontaneous seizure(s) within the last 3 months
Christal L Badour- University of Texas at Austin
- National Institute of Mental Health (NIMH)
Parte responsabile dello studio
Christal L Badour, Promotore-investigatore, Associate Professor, University of Kentucky
Contatti principali dello studio
Contatto: Christal G Badour, PhD, 859-323-3817, [email protected]
2 Centri dello studio in 1 paesi
Kentucky
University of Kentucky, Lexington, Kentucky, 40506, United States
Thomas G Adams, PhD, Contatto, [email protected]
In arruolamento
Texas
University of Texas, Austin, Texas, 78712, United States
Josh Cisler, PhD, Contatto, 512-495-5162, [email protected]
In arruolamento