Treatment Trial for Psychogenic Nonepileptic Seizures (NEST-T_1)

Lifespan

Status and phase: Completed; Phase 4

Conditions: Dissociative Disorders; Convulsion, Non-Epileptic; Stress Disorders, Post-Traumatic; Depression; Conversion Disorder

Treatments: Other: Standard Care; Drug: sertraline; Behavioral: CBT-ip; Other: Combined (sertraline + CBT-ip)

Study type: Interventional

Funder types: Other

Identifiers

NCT00835627

EF122982

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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38 participants in 4 patient groups

sertraline

Active Comparator group

Description:

flexible dose sertraline

Treatment:

Drug: sertraline

CBT-ip

Active Comparator group

Description:

cognitive behavioral therapy-informed psychotherapy for nonepileptic seizures: 12 individual, 1 hour therapy sessions

Treatment:

Behavioral: CBT-ip

Combined (sertraline + CBT-ip)

Active Comparator group

Description:

flexible dose sertraline and cognitive behavioral therapy-informed psychotherapy for nonepileptic seizures: flexible dose sertraline and 12 individual, 1 hour therapy sessions

Treatment:

Other: Combined (sertraline + CBT-ip)

Standard care

Active Comparator group

Description:

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

Treatment:

Other: Standard Care