NCT06570954 Retraining and Control Therapy (ReACT)- Adults
| NCT ID | NCT06570954 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Alabama at Birmingham |
| Condition | Convulsion, Non-Epileptic |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-04-10 |
| Primary Completion | 2027-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-04-10 with a primary completion date of 2027-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to assess sense of control and catastrophic symptom expectations as targets for Retraining and Control Therapy (ReACT- an intervention focused on changing behaviors and thoughts) for treatment of adult psychogenic non-epileptic seizures (PNES, episodes resembling epileptic seizures but with no correlated epileptiform activity). 19 years and older participants diagnosed with PNES who are treated at UAB FND clinic will engage in twelve sessions of ReACT. Participants will be randomly assigned to one of three conditions: no wait, 3-month waiting period, 6-month waiting period. Sense of control over actions will be measured by the magic and turbulence task, a well-validated measure of sense of control. Participants will complete the cold pressor test (CPT) in which participants hold their hand in cool water for as long as possible up to 3 minutes. Catastrophic symptom expectations in response to the CPT will be measured by Pain Catastrophizing Scale (PCS), pain tolerance (time with hand in water) and cortisol response. Target assessments occur 7 days before treatment and 7 days after the 12th treatment session. Participants randomized to the 3-month and 6-month waiting period will also complete these measures one additional time immediately before the beginning of their waiting period. Long term follow-up assessments will occur at 2 months, 6 months and 12 months after the 12th treatment session. PNES frequency will be measured from 30 days before to 12 months after treatment. Participants randomized to the 3-month or 6-month waiting period conditions will log weekly PNES episodes until the start of therapy.
Eligibility Criteria
Inclusion Criteria: * 19 years and older. * Diagnosis of psychogenic non-epileptic seizures by a medical doctor using video-EEG. Exclusion Criteria: * Comorbid Epilepsy * Less than 4 PNES per month * Other paroxysmal nonepileptic events (e.g. episodes related to hypoxic-ischemic phenomena, sleep disorders or migraine-associated disorders) * Participation in other therapy during the study * Severe intellectual disability * Severe mental illness (delusions/hallucinations) Exclusion for CPT: • Blood pressure \>130/80 mmHg
Contact & Investigator
Aaron Fobian, PhD
PRINCIPAL INVESTIGATOR
University of Alabama at Birmingham
Frequently Asked Questions
Who can join the NCT06570954 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Convulsion, Non-Epileptic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06570954 currently recruiting?
Yes, NCT06570954 is actively recruiting participants. Contact the research team at afobian@uabmc.edu for enrollment information.
Where is the NCT06570954 trial being conducted?
This trial is being conducted at Birmingham, United States.
Who is sponsoring the NCT06570954 clinical trial?
NCT06570954 is sponsored by University of Alabama at Birmingham. The principal investigator is Aaron Fobian, PhD at University of Alabama at Birmingham. The trial plans to enroll 50 participants.