Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
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.
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).
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
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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