Treatment for Psychogenic Nonepileptic Seizures and Post-traumatic Stress Disorder Using Prolonged Exposure Therapy (PE) or Psychoeducation for PNES (PNES)

January 14, 2026 updated by: Dr. Lorna Myers, Northeast Regional Epilepsy Group

Pilot Prolonged Exposure Teletherapy Treatment Trial for Psychogenic Nonepileptic Seizures (PNES) and Post-traumatic Stress Disorder (PTSD): A Randomized Clinical Trial

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • New York, New York, United States, 10017
        • Northeast Regional Epilepsy Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

English-speaking adults (18 years and older) Confirmed diagnosis of PNES through video-EEG monitoring Confirmed diagnosis of current PTSD At least one psychogenic non-epileptic seizure in the month prior to beginning treatment.

Exclusion Criteria:

Concurrent mixed epilepsy and PNES or video EEG findings that cannot clearly distinguish epilepsy and PNES Active suicidality Active psychotic symptoms Active substance or alcohol use or dependence that could interfere with participation in therapy Application for disability

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Prolonged exposure
Prolonged exposure is a form of cognitive behavioral treatment that uses exposure to avoided memories and reminders
Active Comparator: Psychoeducational Intervention for PNES
This psychoeducational treatment was based on a similar intervention reported in 2004
A combination of psychoeducation about PNES and skills for emotional regulation and relaxation.
Other Names:
  • PsychoEd for PNES

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nonepileptic seizure frequency
Time Frame: From enrollment until session 12 and at 3, 6 and 12month follow up
frequency of nonepileptic seizures (PNES) per month
From enrollment until session 12 and at 3, 6 and 12month follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beck Depression Inventory (BDI)
Time Frame: From enrollment to session 12 and at 3, 6 and 12 months follow up
Self-report inventory of depressive symptoms 0-13: minimal depression, 14-19: mild, 20-28: moderate, 29-63: severe
From enrollment to session 12 and at 3, 6 and 12 months follow up
Posttraumatic Stress Disorder Checklist (PCL) for DSM 5
Time Frame: From enrollment until session 12 of treatment and at 3, 6 and 12 months follow up
Post traumatic stress symptom checklist scores range from 0-80, higher score means worse outcome
From enrollment until session 12 of treatment and at 3, 6 and 12 months follow up
Posttraumatic Diagnostic Scale
Time Frame: From enrollment until session 12 of treatment and at 3, 6 and 12 months follow up
post traumatic diagnostic scale 0: No symptoms, 1-10: Mild symptoms, 11-20: Moderate symptoms, 21-35: Moderate to severe symptoms, >36: Severe symptoms.
From enrollment until session 12 of treatment and at 3, 6 and 12 months follow up
Clinician Administered PTSD Scale for DSM 5 (CAPS)
Time Frame: From enrollment through session 12 of treatment and at 3, 6 and 12 months follow up
Clinician-Administered PTSD Scale for DSM 5. Severity rating: 0: absent, 1: mild, 2: moderate, 3: severe, 4: extreme
From enrollment through session 12 of treatment and at 3, 6 and 12 months follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Lorna Myers, Ph.D., NEREG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2020

Primary Completion (Actual)

May 12, 2025

Study Completion (Actual)

May 30, 2025

Study Registration Dates

First Submitted

January 7, 2026

First Submitted That Met QC Criteria

January 7, 2026

First Posted (Estimated)

January 15, 2026

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Protocol and data collected over the duration of the study.

IPD Sharing Time Frame

upon completion of final data analysis until indefinitely.

IPD Sharing Access Criteria

Qualified researchers will have access to de-identified IPD, protocol, informed consent) via online data repository

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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