NCT05096273 Retraining and Control Therapy (ReACT): Sense of Control and Symptom Expectations as Targets of a Treatment for PNES
| NCT ID | NCT05096273 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Alabama at Birmingham |
| Condition | Convulsion, Non-Epileptic |
| Study Type | INTERVENTIONAL |
| Enrollment | 68 participants |
| Start Date | 2021-10-28 |
| Primary Completion | 2026-05-31 |
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 68 participants in total. It began in 2021-10-28 with a primary completion date of 2026-05-31.
⚠ 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 pediatric psychogenic non-epileptic seizures (PNES, episodes resembling epileptic seizures but with no medical explanation). 11-18-year-olds diagnosed with PNES will engage in twelve sessions of ReACT. 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 for Children (PCS-C) pain tolerance (time with hand in water) and cortisol response. Target assessments will occur 7 days before treatment, 7 days after 8th treatment session and 7 days after 12th treatment session. Participants will also complete long term follow-up visits via HIPAA-compliant Zoom at 6 months and 12 months after the 12th treatment session where participants will complete questionnaires. PNES frequency will be measured from 30 days before to 12 months after treatment.
Eligibility Criteria
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: * 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 * Severe intellectual disability * Severe mental illness (delusions/hallucinations) Exclusion for CPT: * Blood pressure \>130/80 mmHg for adolescents greater than or equal to 13 years old * Either systolic and/or diastolic blood pressure greater than or equal to 95% based on sex and age for children less than 13 years old
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05096273 clinical trial?
This trial is open to participants of all sexes, aged 11 Years or older, up to 18 Years, 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 NCT05096273 currently recruiting?
Yes, NCT05096273 is actively recruiting participants. Contact the research team at afobian@uabmc.edu for enrollment information.
Where is the NCT05096273 trial being conducted?
This trial is being conducted at Birmingham, United States.
Who is sponsoring the NCT05096273 clinical trial?
NCT05096273 is sponsored by University of Alabama at Birmingham. The trial plans to enroll 68 participants.