Status:
RECRUITING
Retraining and Control Therapy (ReACT) R33 Phase
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Convulsion, Non-Epileptic
Eligibility:
All Genders
11-18 years
Phase:
NA
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 th...
Detailed Description
Participants with PNES and their parent come to our laboratory for a baseline visit and 4 follow-up visits. After the baseline visit, participants are randomized to 12 sessions of either Retraining an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT06007053
Start Date
March 9 2024
End Date
August 31 2026
Last Update
March 13 2025
Active Locations (1)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294