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Completed

NCT Number: NCT07344766

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

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.

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Key information

Conditions

Psychogenic Nonepileptic Seizures (PNESs) Combat Disorders Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Post Traumatic Stress Disorder PTSD Psychogenic Nonepileptic Seizures Seizures Signs and Symptoms Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northeast Regional Epilepsy Group

New York, 10017, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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Treatment and study plan

imaginal and in vivo exposure

Behavioral

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

psychoeducation for psychogenic nonepileptic seizures

Behavioral

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

Other names: PsychoEd for PNES

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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

Sponsors and collaborators

Lead sponsor

Northeast Regional Epilepsy Group

Other

Registry information

Official study title

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

Acronym: PNES

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Jan 15, 2026
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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