Treatment Trial for Psychogenic Nonepileptic Seizures

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.

Conditions

• Convulsion, Non-Epileptic
• Conversion Disorder
• Depression
• Stress Disorders, Post-Traumatic
• Dissociative Disorders

Interventions

DRUG

sertraline

flexible dose sertraline

BEHAVIORAL

CBT-ip

cognitive behavioral therapy-informed psychotherapy for nonepileptic seizures: 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

Standard Care

community care, treatment as usual: routine follow up with existing providers

Sponsors & Collaborators

• American Epilepsy Society

  collaborator OTHER

• Epilepsy Foundation

  collaborator OTHER

• University of Cincinnati

  collaborator OTHER

• Stanford University

  collaborator OTHER

• Rhode Island Hospital

  lead OTHER

Principal Investigators

• W. Curt LaFrance, Jr., MD, MPH · Rhode Island Hospital / Brown Medical School

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

95 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-09-30

Primary Completion

2012-12-31

Completion

2013-06-30

Countries

• United States

Study Locations