Actively Recruiting

Phase Not Applicable
Age: 11Years - 18Years
All Genders
Healthy Volunteers
ID06007053

Retraining and Control Therapy (ReACT): Cognitive Behavioral Treatment Targeting Sense of Control and Catastrophic Symptom Expectations for Pediatric Psychogenic Non-Epileptic Seizures

Led by University of Alabama at Birmingham · Updated on 2026-03-17

160

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Alabama at Birmingham

Lead Sponsor

N

National Institute of Mental Health (NIMH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating Retraining and Control Therapy (ReACT) and supportive therapy for treating pediatric psychogenic non-epileptic seizures (PNES), which are seizure-like episodes without epileptic brain activity. This study focuses on improving sense of control and reducing catastrophic symptom expectations in children aged 11 to 18 diagnosed with PNES. The trial also includes healthy controls for comparison and is sponsored by the University of Alabama at Birmingham. Participants are randomly assigned to receive 12 therapy sessions: one group receives ReACT, a cognitive behavioral intervention teaching control over symptoms and behaviors, while the other group receives supportive therapy focused on discussing stress and daily difficulties. The first session is in-person, and the following 11 sessions are conducted weekly via telehealth. Healthy controls have baseline and follow-up visits similar to PNES participants. During the study, participants and their parents attend a baseline visit and multiple follow-up visits over a year. Assessments include questionnaires on mood, trauma, and symptoms, computerized tasks measuring sense of control, pain tolerance tests, cortisol levels from saliva samples, and monitoring of sleep and PNES episodes using wearable devices. PNES frequency is tracked through diaries from 30 days before treatment through 12 months after. Long-term follow-up visits occur at 6 and 12 months post-treatment, with additional booster therapy sessions offered as needed.

CONDITIONS

Brief Title

Retraining and Control Therapy (ReACT) R33 Phase

Who Can Participate

Age: 11Years - 18Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 11 and 18 years old
  • Diagnosis of psychogenic non-epileptic seizures confirmed by a doctor using video-EEG
  • A parent or guardian willing to participate alongside the child
Not Eligible

You will not qualify if you...

  • Diagnosis of epilepsy
  • Experiencing fewer than 4 PNES episodes per month
  • Other paroxysmal nonepileptic events such as those related to hypoxic-ischemic events, sleep disorders, or migraine-associated disorders
  • Currently participating in other therapy
  • Severe intellectual disability
  • Severe mental illness involving delusions or hallucinations
  • Blood pressure higher than 130/80 mmHg if 13 years or older
  • Blood pressure at or above the 95th percentile for sex and age if under 13 years old
  • Exclusion from cold pressor test based on blood pressure criteria

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 baseline visit (in-person) lasting about 2.5 hours where questionnaires, computer tasks, saliva samples, and sleep tracking are completed.

Outpatient Treatment

Duration - Approximately 12 weeks

Participants receive 12 therapy sessions, either Retraining and Control Therapy (ReACT) or supportive therapy, focused on managing PNES symptoms and improving sense of control.

1 in-person session (up to 2 hours) and 11 weekly telehealth sessions (1 hour each).

Follow-up Assessments

Duration - 2 months post-treatment with additional assessments at 6 and 12 months

Participants complete follow-up visits to assess treatment effects, including tasks, questionnaires, and saliva sampling to measure PNES frequency and symptom changes.

1 in-person visit (2 hours) at 7 days post-treatment, 1 in-person visit (2 hours) at 2 months post-treatment, and 2 telehealth visits (1 hour each) at 6 and 12 months post-treatment.

Trial Site Locations

Total: 1 location

1

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

Actively Recruiting

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Research Team

A

Aaron Fobian, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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