Treatment Outcomes of ReACT for PNES

  • STATUS
    Recruiting
  • days left to enroll
    4
  • participants needed
    84
  • sponsor
    University of Alabama at Birmingham
Updated on 8 September 2021

Summary

This research study is examining the effects of Retraining and Control Therapy (ReACT; an intervention focused on changing behaviors and thoughts) for psychogenic non-epileptic seizures (PNES, episodes resembling epileptic seizures but with no medical explanation). Participants engage in 8 individual therapy sessions consisting of either cognitive behavioral therapy or supportive therapy. Healthy control participants also complete pre-questionnaires and two computer tasks.

Description

Participants come to our laboratory for a total of 11 sessions. During the initial visit, participants complete several questionnaires assessing demographics, personality style, relationships with friends and family, as well as past and current PNES symptoms. They also completed two computer tasks: the magic and turbulence task and a modified Stroop task. Participants must provide EEG results indicating a diagnosis of psychogenic non-epileptic seizures.

Participants receive a PNES diary to record all episodes during the course of the study. They are randomly assigned to either receive ReACT for PNES or supportive therapy, and they return 8 times over the next 8 weeks for therapy sessions. If randomized to ReACT, participants and a family member learn how to change behaviors and thoughts to address PNES. If randomized to supportive therapy, they discuss stressors and how they relate to the PNES.

Procedures are the same for each therapy group. The first therapy session lasts approximately 90 minutes. All subsequent sessions last about one hour. After completing the 8 therapy sessions participants return one week later for a follow-up visit lasting approximately one hour. This visit consists of answering several questionnaires and an interview about current PNES symptoms. Participants return two months later for a final follow-up visit similar to the one week follow up visit. Lastly, participants and their parent are called 1 year after completing treatment and are asked to report PNES frequency over the last 30 days. They are also asked if they think ReACT was helpful, and if so, what the most helpful part of ReACT was.

Healthy controls are matched to participants with PNES based on age (+ or - 1 year), gender, race and family income. They come for 1 laboratory visit to complete the initial visit questionnaires and computer tasks.

Details
Condition Seizure
Treatment Supportive Therapy, CBT for PNES, ReACT
Clinical Study IdentifierNCT02801136
SponsorUniversity of Alabama at Birmingham
Last Modified on8 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

-18 years old
Diagnosis of psychogenic non-epileptic seizures by a medical doctor using video/EEG
Family member (parent if a minor) willing to participate and that the subject with PNES chooses

Exclusion Criteria

Substance use
Psychosis
Severe intellectual disability
Diagnosis of epilepsy is acceptable as long as patient's neurologist confirms that epileptic seizures are currently under control
Healthy controls are matched on age (+ or - 1 year), sex, race and family
income and can have no psychiatric or medical diagnosis
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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