NCT07344766

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 16, 2020

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2025

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 15, 2026

Completed
Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

4.5 years

First QC Date

January 7, 2026

Last Update Submit

January 14, 2026

Conditions

Keywords

Psychotherapyfunctional dissociative seizuresnonepileptic seizurespsychogenic nonepileptic seizures

Outcome Measures

Primary Outcomes (1)

  • Nonepileptic seizure frequency

    frequency of nonepileptic seizures (PNES) per month

    From enrollment until session 12 and at 3, 6 and 12month follow up

Secondary Outcomes (4)

  • Beck Depression Inventory (BDI)

    From enrollment to session 12 and at 3, 6 and 12 months follow up

  • Posttraumatic Stress Disorder Checklist (PCL) for DSM 5

    From enrollment until session 12 of treatment and at 3, 6 and 12 months follow up

  • Posttraumatic Diagnostic Scale

    From enrollment until session 12 of treatment and at 3, 6 and 12 months follow up

  • Clinician Administered PTSD Scale for DSM 5 (CAPS)

    From enrollment through session 12 of treatment and at 3, 6 and 12 months follow up

Study Arms (2)

Prolonged exposure

ACTIVE COMPARATOR
Behavioral: imaginal and in vivo exposure

Psychoeducational Intervention for PNES

ACTIVE COMPARATOR

This psychoeducational treatment was based on a similar intervention reported in 2004

Behavioral: psychoeducation for psychogenic nonepileptic seizures

Interventions

Prolonged exposure is a form of cognitive behavioral treatment that uses exposure to avoided memories and reminders

Prolonged exposure

A combination of psychoeducation about PNES and skills for emotional regulation and relaxation.

Also known as: PsychoEd for PNES
Psychoeducational Intervention for PNES

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northeast Regional Epilepsy Group

New York, New York, 10017, United States

Location

Related Publications (2)

  • Myers L, Vaidya-Mathur U, Lancman M. Prolonged exposure therapy for the treatment of patients diagnosed with psychogenic non-epileptic seizures (PNES) and post-traumatic stress disorder (PTSD). Epilepsy Behav. 2017 Jan;66:86-92. doi: 10.1016/j.yebeh.2016.10.019. Epub 2016 Dec 27.

    PMID: 28038392BACKGROUND
  • Zaroff CM, Myers L, Barr WB, Luciano D, Devinsky O. Group psychoeducation as treatment for psychological nonepileptic seizures. Epilepsy Behav. 2004 Aug;5(4):587-92. doi: 10.1016/j.yebeh.2004.03.005.

    PMID: 15256198BACKGROUND

MeSH Terms

Conditions

Psychogenic Nonepileptic SeizuresCombat DisordersSeizures

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsStress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Lorna Myers, Ph.D.

    NEREG

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, PNES Program

Study Record Dates

First Submitted

January 7, 2026

First Posted

January 15, 2026

Study Start

November 16, 2020

Primary Completion

May 12, 2025

Study Completion

May 30, 2025

Last Updated

January 16, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Protocol and data collected over the duration of the study.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
upon completion of final data analysis until indefinitely.
Access Criteria
Qualified researchers will have access to de-identified IPD, protocol, informed consent) via online data repository
More information

Locations