Recruiting

ReACT

Sponsor:

University of Alabama at Birmingham

Code:

NCT06570954

Conditions

Convulsion, Non-Epileptic

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not 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 adult psychogenic non-epileptic seizures (PNES, episodes resembling epileptic seizures but with no correlated epileptiform activity). 19 years and older participants diagnosed with PNES who are treated at UAB FND clinic will engage in twelve sessions of ReACT. Participants will be randomly assigned to one of three conditions: no wait, 3-month waiting period, 6-month waiting period. 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 (PCS), pain tolerance (time with hand in water) and cortisol response. Target assessments occur 7 days before treatment and 7 days after the 12th treatment session. Participants randomized to the 3-month and 6-month waiting period will also complete these measures one additional time immediately before the beginning of their waiting period. Long term follow-up assessments will occur at 2 months, 6 months and 12 months after the 12th treatment session. PNES frequency will be measured from 30 days before to 12 months after treatment. Participants randomized to the 3-month or 6-month waiting period conditions will log weekly PNES episodes until the start of therapy.

Conditions

Convulsion, Non-Epileptic

Study ID

NCT06570954

Start date

Apr 10, 2025

Status verified date

Jun, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Aug 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 19 years and older.
  • Diagnosis of psychogenic non-epileptic seizures by a medical doctor using video-EEG.

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: No waiting period

At the end of the baseline visit, participants will be randomized to receive Retraining and Control Therapy (ReACT) with no waiting period.

active comparator: 3-month waiting period

At the end of the baseline visit, participants will be randomized to receive Retraining and Control Therapy (ReACT) after a waiting period of 3 months.

active comparator: 6-month waiting period

At the end of the baseline visit, participants will be randomized to receive Retraining and Control Therapy (ReACT) after a waiting period of 6 months.

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 patients to regain control of their body through managing thoughts and behaviors that reinforce the PNES and return to previous activities. The PNES is explained as behaviors learned through classical and operant conditioning.

Primary outcome measure

  • Magic and turbulence task [ Time Frame: 6-12 months ]
  • Pain catastrophizing scale- situation specific [ Time Frame: 6-12 months ]
  • Pain tolerance (time) [ Time Frame: 6-12 months ]
  • Salivary Cortisol [ Time Frame: 6-12 months ]
  • Pain Rating Scale [ Time Frame: 6-12 months ]
  • Stroop task [ Time Frame: 6-12 months ]

Central Contacts and Locations

Central contacts

Stephanie Mueller, PhD

smueller@uabmc.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Jun 11, 2026

Last verified

Jun, 2026

Keywords

  • 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 2026-06-11.