NCT06007053Recruiting
Retraining and Control Therapy (ReACT) R33 Phase
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
Source: ClinicalTrials.gov · Last updated 17 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- First submitted
- 11 Aug 2023
- Start date
- 9 Mar 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- University of Alabama at Birmingham
- Diseases
- Epilepsy
- NCT number
- NCT06007053
What you commit to
- Study type: Interventional
- Planned participants: 160
- From 9 Mar 2024 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in other therapy during the study
Other illness
- Comorbid Epilepsy
- Other paroxysmal nonepileptic events (e.g. episodes related to hypoxic-ischemic phenomena, sleep disorders or migraine-associated disorders)
- Severe mental illness (delusions/hallucinations)
- Exclusion for CPT:
Age
- 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
Other
- Less than 4 PNES per month
- Severe intellectual disability
Who the study is looking for
- 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.
Age in the registry: 11 years to 18 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.