Treatment Trial for Psychogenic Nonepileptic Seizures
Condition: Convulsion, Non-Epileptic; Conversion Disorder; Depression; Stress Disorders, Post-Traumatic; Dissociative Disorders
MeSH terms: Seizures; Psychogenic Nonepileptic Seizures; Stress Disorders, Post-Traumatic; Conversion Disorder; Hysteria; Dissociative Disorders
Study type: Interventional
Phase: Phase 4

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.
    

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.
    

Intervention name(s): sertraline; CBT-ip; Combined (sertraline + CBT-ip); Standard Care
Intervention type(s): Drug; Behavioral; Other; Other
Intervention description(s): flexible dose sertraline; cognitive behavioral therapy-informed psychotherapy for nonepileptic seizures: 12 individual 1 hour therapy sessions; flexible dose sertraline and cognitive behavioral therapy-informed psychotherapy for nonepileptic seizures: flexible dose sertraline and 12, individual 1 hour therapy sessions; community care, treatment as usual: routine follow up with existing providers
Other intervention name(s): Zoloft; Zoloft; CBT-ip; TAU, standard care
Intervention MeSH terms: Sertraline
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Treatment; Cognitive Behavior Therapy; pharmacotherapy; psychogenic nonepileptic seizures; pseudoseizures; dissociative seizures; conversion disorder