RecruitingNot ApplicableNCT06007053

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


Sponsor

University of Alabama at Birmingham

Enrollment

160 participants

Start Date

Mar 9, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 11 YearsMax Age: 18 Years

Inclusion Criteria3

  • -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 Criteria9

  • 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

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Interventions

BEHAVIORALReACT

ReACT is a novel cognitive behavioral treatment and is a PNES intervention that targets sense of control and catastrophic symptom expectations. ReACT consists of 12 sessions of therapy focused on teaching adolescents to regain control of their body through managing thoughts and behaviors that reinforce the PNES and return to previous activities. It teaches parents how to respond to PNES in a manner that encourages the adolescents to regain control of their body. The PNES is explained as behaviors learned through classical and operant conditioning.

BEHAVIORALSupportive Therapy

The supportive therapy treatment consists of 12 sessions of therapy focused on discussing daily difficulties and/or stressors they experience and identifying stress triggers for PNES. The PNES is explained as physical manifestations of psychological stress.


Locations(1)

University of Alabama at Birmingham

Birmingham, Alabama, United States

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