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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prolonged exposure | Active Comparator |
| |
| Psychoeducational Intervention for PNES | Active Comparator | This psychoeducational treatment was based on a similar intervention reported in 2004 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| imaginal and in vivo exposure | Behavioral | Prolonged exposure is a form of cognitive behavioral treatment that uses exposure to avoided memories and reminders |
|
| Measure | Description | Time Frame |
|---|---|---|
| Nonepileptic seizure frequency | frequency of nonepileptic seizures (PNES) per month | From enrollment until session 12 and at 3, 6 and 12month follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Beck Depression Inventory (BDI) | 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 |
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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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| Name | Affiliation | Role |
|---|---|---|
| Lorna Myers, Ph.D. | NEREG | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northeast Regional Epilepsy Group | New York | New York | 10017 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28038392 | Background | 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. | |
| 15256198 | Background | 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. |
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Protocol and data collected over the duration of the study.
upon completion of final data analysis until indefinitely.
Qualified researchers will have access to de-identified IPD, protocol, informed consent) via online data repository
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| psychoeducation for psychogenic nonepileptic seizures | Behavioral | A combination of psychoeducation about PNES and skills for emotional regulation and relaxation. |
|
|
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 | 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) | 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 |
| ID | Term |
|---|---|
| D000091323 | Psychogenic Nonepileptic Seizures |
| D003130 | Combat Disorders |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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