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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 11
Maximum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
Contact Information
Primary
Aaron Fobian, PhD
afobian@uabmc.edu
205-934-2241
Time Frame
Start Date: 2024-03-09
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 160
Treatments
Experimental: ReACT Intervention
At the end of the baseline visit, half of the participants will be randomized to receive Retraining and Control Therapy (ReACT)
Active_comparator: Supportive Therapy
At the end of the baseline visit, half of the participants will be randomized to receive supportive therapy
No_intervention: Healthy Control
Healthy controls are ages 12-18 with no significant comorbid medical or mental health conditions. Healthy controls and their parent come for 1 baseline laboratory visit and a follow up visit 13 weeks after the baseline visit. These visits will be identical to baseline and follow-up visits of children with PNES.
Related Therapeutic Areas
Sponsors
Leads: University of Alabama at Birmingham
Collaborators: National Institute of Mental Health (NIMH)

This content was sourced from clinicaltrials.gov