Psychogenic Nonepileptic Seizures (PNESs)PNESNCT07344766
Treatment for Psychogenic Nonepileptic Seizures and Post-traumatic Stress Disorder Using Prolonged Exposure Therapy (PE) or Psychoeducation for PNES
A study testing imaginal and in vivo exposure and psychoeducation for psychogenic nonepileptic seizures in people with Psychogenic Nonepileptic Seizures (PNESs) and Post Traumatic Stress Disorder PTSD, run by Northeast Regional Epilepsy Group at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychogenic Nonepileptic Seizures (PNESs), Post Traumatic Stress Disorder PTSD
- What is being tested?
- imaginal and in vivo exposure and psychoeducation for psychogenic nonepileptic seizures
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2020to 30 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Northeast Regional Epilepsy Group
New York, New York, 10017
About this study
Official title: 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.
Read the 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.
- Being tested
- imaginal and in vivo exposure, psychoeducation for psychogenic nonepileptic seizures
- Keywords
- Psychotherapy, functional dissociative seizures, nonepileptic seizures, psychogenic nonepileptic seizures
- Medical subject headings
- Psychogenic Nonepileptic Seizures, Combat Disorders, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imaginal and in vivo exposureBehavioural
Prolonged exposure is a form of cognitive behavioral treatment that uses exposure to avoided memories and reminders
psychoeducation for psychogenic nonepileptic seizuresBehavioural
Also called PsychoEd for PNES
A combination of psychoeducation about PNES and skills for emotional regulation and relaxation.
| Study group | Role | What they receive |
|---|---|---|
| Prolonged exposure | Active comparator | Not described Receives: Behavioral: imaginal and in vivo exposure |
| Psychoeducational Intervention for PNES | Active comparator | This psychoeducational treatment was based on a similar intervention reported in 2004 Receives: Behavioral: psychoeducation for psychogenic nonepileptic seizures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nonepileptic seizure frequency
frequency of nonepileptic seizures (PNES) per month
Measured: From enrollment until session 12 and at 3, 6 and 12month follow up
Secondary outcomes (4)
Beck Depression Inventory (BDI)
Self-report inventory of depressive symptoms 0-13: minimal depression, 14-19: mild, 20-28: moderate, 29-63: severe
Measured: From enrollment to session 12 and at 3, 6 and 12 months follow up
Posttraumatic Stress Disorder Checklist (PCL) for DSM 5
Post traumatic stress symptom checklist scores range from 0-80, higher score means worse outcome
Measured: From enrollment until session 12 of treatment and at 3, 6 and 12 months follow up
Posttraumatic Diagnostic Scale
post traumatic diagnostic scale 0: No symptoms, 1-10: Mild symptoms, 11-20: Moderate symptoms, 21-35: Moderate to severe symptoms, >36: Severe symptoms.
Measured: From enrollment until session 12 of treatment and at 3, 6 and 12 months follow up
Clinician Administered PTSD Scale for DSM 5 (CAPS)
Clinician-Administered PTSD Scale for DSM 5. Severity rating: 0: absent, 1: mild, 2: moderate, 3: severe, 4: extreme
Measured: From enrollment through session 12 of treatment and at 3, 6 and 12 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start16 Nov 2020
- Primary completion12 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Psychogenic Nonepileptic Seizures (PNESs)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northeast Regional Epilepsy Group
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Lorna Myers, Northeast Regional Epilepsy Group
- Investigators
- Lorna Myers, Ph.D., Principal investigator, NEREG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07344766
- Sponsor's protocol ID
- WCGIRB 1280734
- Acronym
- PNES
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2026
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Protocol and data collected over the duration of the study.
Publications
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.
PubMed 28038392Zaroff 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.
PubMed 15256198
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Prolonged Exposure Teletherapy Treatment Trial for Psychogenic Nonepileptic Seizures (PNES) and Post-traumatic Stress Disorder (PTSD): A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07344766
- Acronym / sponsor ID
- PNES / WCGIRB 1280734
- Keywords
- Psychotherapy, functional dissociative seizures, nonepileptic seizures, psychogenic nonepileptic seizures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Northeast Regional Epilepsy GroupUniversity, hospital or other
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 12 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prolonged exposure | Active comparator | Behavioral: imaginal and in vivo exposure |
| Psychoeducational Intervention for PNES | Active comparator | Behavioral: psychoeducation for psychogenic nonepileptic seizuresThis psychoeducational treatment was based on a similar intervention reported in 2004 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| imaginal and in vivo exposureProlonged exposure is a form of cognitive behavioral treatment that uses exposure to avoided memories and reminders | Behavioural | Prolonged exposure |
| psychoeducation for psychogenic nonepileptic seizuresAlso: PsychoEd for PNESA combination of psychoeducation about PNES and skills for emotional regulation and relaxation. | Behavioural | Psychoeducational Intervention for PNES |
Primary outcome
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
4 secondary outcomes
Beck Depression Inventory (BDI)
Time frame: 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
Posttraumatic Diagnostic Scale
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Background: PubMed 28038392Myers 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.
- Background: PubMed 15256198Zaroff 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.
- Individual participant dataSharing planned: Yes. Protocol and data collected over the duration of the study.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorna Myers, Ph.D. principal investigator
NEREG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing imaginal and in vivo exposure and psychoeducation for psychogenic nonepileptic seizures in people with Psychogenic Nonepileptic Seizures (PNESs) and Post Traumatic Stress Disorder PTSD, run by Northeast Regional Epilepsy Group at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nonepileptic seizure frequency (time frame: From enrollment until session 12 and at 3, 6 and 12month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07344766, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.