RECRUITING

Retraining and Control Therapy (ReACT): Sense of Control and Symptom Expectations As Targets of a Treatment for PNES

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 medical explanation). 11-18-year-olds diagnosed with PNES will engage in twelve sessions of ReACT. 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 will occur 7 days before treatment, 7 days after 8th treatment session and 7 days after 12th treatment session. Participants will also complete long term follow-up visits via HIPAA-compliant Zoom at 6 months and 12 months after the 12th treatment session where participants will complete questionnaires. PNES frequency will be measured from 30 days before to 12 months after treatment.

Official Title

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)

Quick Facts

Study Start:2021-10-28
Study Completion:2026-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05096273

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:11 Years to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * 9-18 years old.
  2. * Diagnosis of psychogenic non-epileptic seizures by a medical doctor using video-EEG.
  3. * Family member (parent if a minor) willing to participate and that the subject with PNES chooses.
  1. * Comorbid Epilepsy
  2. * Less than 4 PNES per month
  3. * Other paroxysmal nonepileptic events (e.g. episodes related to hypoxic-ischemic phenomena, sleep disorders or migraine-associated disorders)
  4. * Participation in other therapy
  5. * Severe intellectual disability
  6. * Severe mental illness (delusions/hallucinations)
  7. * Blood pressure \>130/80 mmHg for adolescents greater than or equal to 13 years old
  8. * 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

Contacts and Locations

Study Contact

Aaron Fobian, PhD
CONTACT
205-934-2241
afobian@uabmc.edu

Study Locations (Sites)

Sparks Center Office of Psychiatric Research
Birmingham, Alabama, 35294
United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-28
Study Completion Date2026-07-31

Study Record Updates

Study Start Date2021-10-28
Study Completion Date2026-07-31

Terms related to this study

Additional Relevant MeSH Terms

  • Convulsion, Non-Epileptic