- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07344766
Treatment for Psychogenic Nonepileptic Seizures and Post-traumatic Stress Disorder Using Prolonged Exposure Therapy (PE) or Psychoeducation for PNES (PNES)
Pilot Prolonged Exposure Teletherapy Treatment Trial for Psychogenic Nonepileptic Seizures (PNES) and Post-traumatic Stress Disorder (PTSD): A Randomized Clinical Trial
Study Overview
Status
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10017
- Northeast Regional Epilepsy Group
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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Study Plan
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 |
|---|---|
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Active Comparator: Prolonged exposure
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Prolonged exposure is a form of cognitive behavioral treatment that uses exposure to avoided memories and reminders
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Active Comparator: Psychoeducational Intervention for PNES
This psychoeducational treatment was based on a similar intervention reported in 2004
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A combination of psychoeducation about PNES and skills for emotional regulation and relaxation.
Other Names:
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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
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frequency of nonepileptic seizures (PNES) per month
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From enrollment until session 12 and at 3, 6 and 12month follow up
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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
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From enrollment to session 12 and at 3, 6 and 12 months follow up
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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
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Post traumatic stress symptom checklist scores range from 0-80, higher score means worse outcome
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From enrollment until session 12 of treatment and at 3, 6 and 12 months follow up
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Posttraumatic Diagnostic Scale
Time Frame: From enrollment until session 12 of treatment and at 3, 6 and 12 months follow up
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post traumatic diagnostic scale 0: No symptoms, 1-10: Mild symptoms, 11-20: Moderate symptoms, 21-35: Moderate to severe symptoms, >36: Severe symptoms.
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From enrollment until session 12 of treatment and at 3, 6 and 12 months follow up
|
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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
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Clinician-Administered PTSD Scale for DSM 5. Severity rating: 0: absent, 1: mild, 2: moderate, 3: severe, 4: extreme
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From enrollment through session 12 of treatment and at 3, 6 and 12 months follow up
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Collaborators and Investigators
Investigators
- Principal Investigator: Lorna Myers, Ph.D., NEREG
Publications and helpful links
General 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- WCGIRB 1280734
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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