CompletedNot Applicable

Treatment Outcomes of ReACT for PNES

United States94 participantsStarted 2016-06

Plain-language 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.

Who can participate

Age range

9 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 9-18 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

PNES Frequency

Timeframe: 14 months (4 months from baseline to 2 months after the final therapy session and then again for 30 days at the 1-year followup)

Stroop Task

Timeframe: 4 months

Magic and turbulence task

Timeframe: 4 months

Trial details

NCT IDNCT02801136

SponsorUniversity of Alabama at Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12

View on ClinicalTrials.gov More Convulsion, Non-Epileptic trials