Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 10:19 PM
Study NCT ID:
NCT07344766
Status:
COMPLETED
Last Update Posted:
2026-01-16
First Post:
2026-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment for Psychogenic Nonepileptic Seizures and Post-traumatic Stress Disorder Using Prolonged Exposure Therapy (PE) or Psychoeducation for PNES
Sponsor:
Northeast Regional Epilepsy Group
Organization:
Study Overview
Official Title:
Pilot Prolonged Exposure Teletherapy Treatment Trial for Psychogenic Nonepileptic Seizures (PNES) and Post-traumatic Stress Disorder (PTSD): A Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PNES
Brief Summary:
An outpatient randomized controlled clinical trial conducted at the Northeast Regional Epilepsy Group's PNES Program, involving mental health clinicians certified in PE and trained in administering PsychoEd.
Detailed Description:
A randomized parallel group trial was utilized to compare two therapeutic interventions for PNES, PE or PsychoEd, both delivered remotely via teletherapy. Each psychotherapeutic modality provided 12, 90-minute sessions. Seizure frequency was the primary outcome measure. Secondary outcome measures were depression (Beck Depression Inventory) and post-traumatic stress symptomatology (Post-Traumatic Disorder Diagnostic Scale and PTSD Checklist). Data was collected prospectively, including baseline measures before initiating treatment, upon treatment completion, and at follow-up intervals of 3, 6, and 12-months post-treatment.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: