Retraining and Control Therapy (ReACT) R33 Phase
Recruiting now · Not applicable
Conditions studied: Convulsion, Non-Epileptic
In brief
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 correlated epileptiform activity). 11-18-year-olds diagnosed with PNES will engage in twelve sessions of either ReACT or supportive therapy. 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 occur 7 days before treatment, 7 days after 12th treatment session, and 2 months after the 12th treatment session. Long term follow-up assessments will occur 6 months and 12 months after the 12th treatment session. PNES frequency will be measured from 30 days before to 12 months after treatment.
Key facts
- Study ID
- NCT06007053
- Run by
- University of Alabama at Birmingham
- People needed
- 160
- Starts
- 2024-03-09
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-03-17
Who can join
Age: 11 and older, up to 18. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
Full record on ClinicalTrials.gov
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