Therapy to improve control and reduce symptoms in children with non-epileptic seizures
Retraining and Control Therapy (ReACT): Sense of Control and Catastrophic Symptom Expectations as Targets of a Cognitive Behavioral Treatment for Pediatric Psychogenic Non-epileptic Seizures (PNES) - R33 Phase
This study is testing a new therapy called ReACT to see if it can help children aged 11-18 with non-epileptic seizures feel more in control and reduce their symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 11 Years to 18 Years |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT06007053 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Retraining and Control Therapy (ReACT) in treating pediatric patients aged 11-18 diagnosed with psychogenic non-epileptic seizures (PNES). Participants will be randomly assigned to either ReACT or supportive therapy, engaging in twelve sessions, with the first session conducted in-person and the remaining via telehealth. The study aims to measure changes in sense of control and catastrophic symptom expectations through various assessments, including pain tolerance and cortisol response. Data will be collected through questionnaires, PNES diaries, and physiological measures to assess treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are children aged 11-18 diagnosed with psychogenic non-epileptic seizures who have a supportive family member willing to participate.
Not a fit: Patients with comorbid epilepsy, severe intellectual disabilities, or severe mental illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve the management of non-epileptic seizures in children by enhancing their sense of control and reducing anxiety related to symptoms.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in using behavioral therapies for managing non-epileptic seizures.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 11-18 years old. * Diagnosis of psychogenic non-epileptic seizures by a medical doctor using video-EEG. * Family member (parent/guardian 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 during the study * 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
Where this trial is running
Birmingham, Alabama
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Principal investigator: Aaron Fobian, PhD — University of Alabama at Birmingham
- Study coordinator: Aaron Fobian, PhD
- Email: afobian@uabmc.edu
- Phone: 205-934-2241
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.