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Recruiting NCT05096273

Retraining and Control Therapy (ReACT): Sense of Control and Symptom Expectations as Targets of a Treatment for PNES

Trial Parameters

Condition Convulsion, Non-Epileptic
Sponsor University of Alabama at Birmingham
Study Type INTERVENTIONAL
Phase N/A
Enrollment 68
Sex ALL
Min Age 11 Years
Max Age 18 Years
Start Date 2021-10-28
Completion 2026-05-31
Interventions
ReACT

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

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