Recruiting

ReACT

Sponsor:

University of Alabama at Birmingham

Code:

NCT05096273

Conditions

Convulsion, Non-Epileptic

Eligibility Criteria

Sex: All

Age: 11 - 18

Healthy Volunteers: Accepted

Interventions

ReACT

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 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.

Conditions

Convulsion, Non-Epileptic

Study ID

NCT05096273

Start date

Oct 28, 2021

Status verified date

Aug, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 11 - 18

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 9-18 years old.
  • Diagnosis of psychogenic non-epileptic seizures by a medical doctor using video-EEG.
  • Family member (parent 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
  • 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

68 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CPT- Pain relief lotion

During the initial visit participant will do the cold pressor test twice to assess catastrophic symptom expectations. After completing the 1st CPT, participants will be randomized to receive a pain relief lotion or pain sensitivity lotion. Participants will then repeat the CPT with the lotion applied to their hand.

experimental: CPT- Pain sensitivity lotion

During the initial visit participant will do the cold pressor test twice to assess catastrophic symptom expectation. After completing the 1st CPT, participants will be randomized to receive a pain relief lotion or pain sensitivity lotion. Participants will then repeat the CPT with the lotion applied to their hand.

active comparator: ReACT for PNES- Booster therapy sessions

After completing the 12 therapy sessions, half of the participants will be randomized to receive 2 booster therapy sessions, 3 months and 9 months after the 12th ReACT treatment session.

experimental: ReACT for PNES- No Booster therapy sessions

After completing the 12 ReACT treatment sessions, half of the participants will be randomized to not receive the 2 booster therapy sessions.

no intervention: Healthy Control

Healthy controls are matched to participants with PNES based on age (+ or - 1 year), gender, race and family income. 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

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 response to Cold Pressor Test [ 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

Sparks Center Office of Psychiatric Research

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Badhma Valaiyapathi, MD

2059754205bvalaiyapathi@uabmc.edu

Aaron Fobian, PhD

2059342241afobian@uab.edu

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-20. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-08-26.