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Behavioral Intervention

Cognitive Behavioral Therapy for Nonepileptic Seizures

N/A
Waitlist Available
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
9-18 years old
Diagnosis of psychogenic non-epileptic seizures by a medical doctor using video-EEG
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 months
Awards & highlights

Study Summary

This trial is testing whether a behavioral intervention can help people with a seizure disorder that has no medical explanation.

Who is the study for?
This trial is for young people aged 9-18 with a diagnosis of psychogenic non-epileptic seizures (PNES) confirmed by video-EEG. They must experience at least four PNES per month and have a family member willing to participate. It's not suitable for those with severe mental illness, other nonepileptic events, participation in another therapy, severe intellectual disability, or comorbid epilepsy.Check my eligibility
What is being tested?
The study tests Retraining and Control Therapy (ReACT), which aims to improve the sense of control and reduce catastrophic symptom expectations in children with PNES through twelve sessions. The effectiveness will be measured using tasks like holding a hand in cool water and questionnaires before treatment, after certain sessions, and up to one year later.See study design
What are the potential side effects?
Since ReACT is a behavioral intervention focusing on changing thoughts and behaviors rather than medication, it may not have typical drug side effects. However, participants might experience discomfort during the cold pressor test or stress from confronting their condition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 9 and 18 years old.
Select...
My seizures have been diagnosed as non-epileptic by a doctor using a special video test.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Magic and turbulence task
Pain Rating Scale
Pain catastrophizing scale for children- situation specific
+3 more
Secondary outcome measures
Anxiety Sensitivity Index (ASI)
COVID-19 Functional Neurological Disorders (FND) Questionnaire
Childhood Trauma Questionnaire
+19 more

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: ReACT for PNES- No Booster therapy sessionsExperimental Treatment1 Intervention
After completing the 12 ReACT treatment sessions, half of the participants will be randomized to not receive the 2 booster therapy sessions.
Group II: CPT- Pain sensitivity lotionExperimental Treatment1 Intervention
During the initial visit participant will do the cold pressor test twice to assess catastrophic symptom expectation. After completing the 1st CPT, participants will be randomized to receive a pain relief lotion or pain sensitivity lotion. Participants will then repeat the CPT with the lotion applied to their hand.
Group III: CPT- Pain relief lotionExperimental Treatment1 Intervention
During the initial visit participant will do the cold pressor test twice to assess catastrophic symptom expectations. After completing the 1st CPT, participants will be randomized to receive a pain relief lotion or pain sensitivity lotion. Participants will then repeat the CPT with the lotion applied to their hand.
Group IV: Healthy ControlActive Control1 Intervention
Healthy controls are matched to participants with PNES based on age (+ or - 1 year), gender, race and family income. Healthy controls and their parent come for 1 baseline laboratory visit and a follow up visit 13 weeks after the baseline visit. These visits will be identical to baseline and follow-up visits of children with PNES.
Group V: ReACT for PNES- Booster therapy sessionsActive Control1 Intervention
After completing the 12 therapy sessions, half of the participants will be randomized to receive 2 booster therapy sessions, 3 months and 9 months after the 12th ReACT treatment session.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ReACT
2016
N/A
~100

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,581 Previous Clinical Trials
2,277,961 Total Patients Enrolled
1 Trials studying Nonepileptic Seizures
224 Patients Enrolled for Nonepileptic Seizures

Media Library

ReACT (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05096273 — N/A
Nonepileptic Seizures Research Study Groups: Healthy Control, ReACT for PNES- Booster therapy sessions, ReACT for PNES- No Booster therapy sessions, CPT- Pain relief lotion, CPT- Pain sensitivity lotion
Nonepileptic Seizures Clinical Trial 2023: ReACT Highlights & Side Effects. Trial Name: NCT05096273 — N/A
ReACT (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05096273 — N/A
Nonepileptic Seizures Patient Testimony for trial: Trial Name: NCT05096273 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What aim is this trial attempting to accomplish?

"This 16-month trial has been designed to assess the Stroop task, Anxiety Sensitivity Index (ASI), Quality of Life in Epilepsy for Adolescents (QOLIE-AD-48) and Functional Disability Inventory (FDI). The ASI is a measure of catastrophic symptom expectations with higher scores indicating greater anxiety; QOLIE-AD-48 evaluates health related quality of life while FDI captures physical functioning and disability. Participant's responses will be collected at baseline visit, 1 week after 8th therapy session, 6 months and 12 months post final therapy sessions."

Answered by AI

Are individuals of advanced age eligible to participate in this trial?

"This trial is taking in participants who are between the ages of 11 and 18."

Answered by AI

Are there opportunities available for patients to participate in this trial?

"Indeed, the clinicaltrials.gov website reports that recruitment for this medical study is ongoing. It was initially posted on October 28th 2021 and edited most recently on May 4th 2022, with 68 participants sought from one centre."

Answered by AI

Can I enroll in this clinical trial?

"68 minors aged 11-18 with psychogenic non-epileptic seizures, as diagnosed by a physician and confirmed using video EEG are eligible for enrolment in this trial. Furthermore, the child's family must be willing to participate and the subject themself should choose to take part."

Answered by AI

What is the participant count for this clinical investigation?

"Yes, the evidence presented on clinicaltrials.gov affirms that this particular study is actively recruiting participants. This trial was originally posted on October 28th 2021 and has been recently updated on May 4th 2022. 68 volunteers are needed at a single location."

Answered by AI

Who else is applying?

What state do they live in?
Nebraska
What site did they apply to?
Sparks Center Office of Psychiatric Research
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I’ve tried psychotherapy. It was helpful until my wife needed therapy herself. I am contacting you guys to see what the behavioral changes can reflect in my seizure frequency. Currently I have a non epileptic seizures about once every three months.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

If I’ve had 2-4 months of psychotherapy already, can you offer more behavioral changes that can help my seizures?
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Sparks Center Office of Psychiatric Research: < 24 hours
Average response time
  • < 1 Day
Recent research and studies
clinicaltrials.govStudy
Retraining and Control Therapy (ReACT): Sense of Control and Symptom Expectations as Targets of a Treatment for PNES
Aaron Fobian 2021. "Retraining and Control Therapy (ReACT): Sense of Control and Symptom Expectations as Targets of a Treatment for PNES". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05096273.
~31 spots leftby May 2026
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