NEST-T_1: Treatment Trial for Psychogenic Nonepileptic Seizures

Sponsor

Rhode Island Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00835627

Collaborator

American Epilepsy Society (Other), Epilepsy Foundation (Other), University of Cincinnati (Other), Stanford University (Other)

Enrollment

Locations

Arms

Duration (Months)

12.7

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators propose that patients who receive targeted pharmacotherapy (sertraline) or focused psychotherapy (cognitive behavioral therapy-informed psychotherapy (CBT-ip) for NES) or combined treatment (CBT-ip + sertraline) will report fewer nonepileptic seizures (NES) compared to patients who receive community care / treatment as usual (TAU). The purpose of this study is to provide pilot testing and data to inform the future multicenter randomized controlled trial based on the hypothesis.

Condition or Disease	Intervention/Treatment	Phase
Convulsion, Non-Epileptic Conversion Disorder Depression Stress Disorders, Post-Traumatic Dissociative Disorders	Drug: sertraline Behavioral: CBT-ip Other: Combined (sertraline + CBT-ip) Other: Standard Care	Phase 4

Detailed Description

This is a pilot, prospective, multi-center, randomized controlled trial, that assesses the number of NES in patients treated with either flexible dose sertraline (Zoloft), cognitive behavioral therapy-informed psychotherapy (CBT-ip), combined therapy (sertraline + CBT-ip) or community care (treatment as usual TAU). This study will provide outcomes data and the effect size necessary for a future R01, multi-center randomized control trial. Secondary objective variables include reduction in depression, anxiety, impulsivity scores, and improvement in psychosocial functioning.

After being diagnosed with NES by video EEG monitoring (vEEG), up to 40 participants will be enrolled and monitored during a two week lead in period for their baseline NES and psychosocial symptoms and functioning. At week 2, they will be randomized to either: flexible dose sertraline (25 to 200mg), CBT, CBT+med, or to the control arm, TAU. Participants randomized to the sertraline arm will be titrated over 6 weeks up to 200mg or to dose limited by side effects. The subjects will stay on their maximum fixed dose for the next 4 weeks. At week 10, the subjects may elect to remain on the sertraline or they can taper off the medication over the final two weeks of the treatment trial. Those randomized to the CBT-ip arm will receive 12 weekly sessions of CBT-ip for NES. Those randomized to the CBT-ip + med arm will receive both treatments. Those randomized to the TAU arm will follow with their treatment providers.

After the treatment trial, the subjects will have follow up phone calls at month 4, 8, and 12 after enrollment to assess seizure status, medication usage, and global functioning.

Upon enrollment, subjects will be evaluated with a structured psychiatric and neurological exam, and with bi-weekly, 30 to 60 minute appointments where they will complete symptom and function scales. They will keep a seizure diary to evaluate their daily seizure activity.

Study Design

Study Type:

Interventional

Actual Enrollment :

38 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Medication and Psychotherapy Treatment Trial for Psychogenic Nonepileptic Seizures

Study Start Date :

Sep 1, 2008

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: sertraline flexible dose sertraline	Drug: sertraline flexible dose sertraline Other Names: Zoloft
Active Comparator: CBT-ip cognitive behavioral therapy-informed psychotherapy for nonepileptic seizures: 12 individual, 1 hour therapy sessions	Behavioral: CBT-ip cognitive behavioral therapy-informed psychotherapy for nonepileptic seizures: 12 individual 1 hour therapy sessions
Active Comparator: Combined (sertraline + CBT-ip) flexible dose sertraline and cognitive behavioral therapy-informed psychotherapy for nonepileptic seizures: flexible dose sertraline and 12 individual, 1 hour therapy sessions	Other: Combined (sertraline + CBT-ip) flexible dose sertraline and cognitive behavioral therapy-informed psychotherapy for nonepileptic seizures: flexible dose sertraline and 12, individual 1 hour therapy sessions Other Names: Zoloft CBT-ip
Active Comparator: Standard care community care / treatment as usual: routine follow up with existing providers	Other: Standard Care community care, treatment as usual: routine follow up with existing providers Other Names: TAU, standard care

Outcome Measures

Primary Outcome Measures

seizure frequency [weekly]

Secondary Outcome Measures

Identify predictors of response from the following 3 groups: clinical diagnoses [baseline]
psychological symptoms [bi-weekly]
socio-demographic variables [bi-weekly]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 95 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Video electroencephalogram (EEG) confirmed diagnosis of NES
Have at least one nonepileptic seizure per month
Able to complete self report symptom scales
Not receiving optimized sertraline

Exclusion Criteria:

Equivocal EEG findings
using monoamine oxidase inhibitors (MAOIs), pimozide, or sumatriptan
allergy/sensitivity to sertraline
current alcohol/drug dependence
serious medical illness requiring current hospitalization

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Stanford	California	United States	94305
2	University of Cincinnati	Cincinnati	Ohio	United States	45267
3	Rhode Island Hospital	Providence	Rhode Island	United States	02903