Recruiting

ReACT

Sponsor:

University of Alabama at Birmingham

Code:

NCT06007053

Conditions

Convulsion, Non-Epileptic

Eligibility Criteria

Sex: All

Age: 11 - 18

Healthy Volunteers: Accepted

Interventions

ReACT

Supportive Therapy

Study Details

Brief 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.

Conditions

Convulsion, Non-Epileptic

Study ID

NCT06007053

Start date

Mar 9, 2024

Status verified date

Mar, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 11 - 18

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

ReACT

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.

Supportive 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.

Primary outcome measure

  • Magic and turbulence task [ Time Frame: 7 months ]
  • Pain catastrophizing scale for children- situation specific [ Time Frame: 7 months ]
  • Pain tolerance (time) [ Time Frame: 7 months ]
  • Salivary Cortisol [ Time Frame: 7 months ]
  • Pain Rating Scale [ Time Frame: 7 months ]
  • Stroop task [ Time Frame: 7 months ]

Central Contacts and Locations

Central contacts

Aaron Fobian, PhD

205-934-2241afobian@uabmc.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Badhma Valaiyapathi, MBBS, MPH

205-975-4205drbadhma@uab.edu

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Mar 17, 2026

Last verified

Mar, 2026

Keywords

  • Supportive therapy
  • ReACT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-03-17.