Actively Recruiting

Phase Not Applicable
Age: 19Years +
All Genders
ID06570954

Retraining and Control Therapy (ReACT) for Adult Functional Seizures: Cognitive Behavioral Treatment Targeting Sense of Control and Symptom Expectations

Led by University of Alabama at Birmingham · Updated on 2025-06-06

50

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

Sponsors

U

University of Alabama at Birmingham

Lead Sponsor

N

National Institute of Mental Health (NIMH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to evaluate Retraining and Control Therapy (ReACT), a cognitive behavioral treatment targeting sense of control and catastrophic symptom expectations in adults with psychogenic non-epileptic seizures (PNES), which are seizure-like episodes not caused by epileptic brain activity. The study involves adults aged 19 and older diagnosed with PNES and treated at the UAB FND clinic. It compares immediate treatment to waiting periods of 3 or 6 months to assess how these factors affect outcomes. Participants will be randomly assigned to one of three groups: no waiting period, a 3-month waiting period, or a 6-month waiting period before starting ReACT. The therapy consists of 12 sessions delivered weekly through telehealth, with the first session lasting up to two hours and the rest lasting one hour each. The study includes baseline and follow-up visits to measure treatment effects before, during, and after therapy, including long-term assessments up to 12 months post-treatment. During the study, participants complete questionnaires about mood, relationships, and PNES symptoms, along with cognitive tests and biological measures like cortisol response to a cold pressor test. They track seizure frequency with diaries and wear devices to monitor sleep and seizure severity. Outcome measures include sense of control, pain catastrophizing, pain tolerance, cortisol levels, and seizure frequency over time. Follow-up visits occur up to a year after treatment to evaluate lasting effects and safety.

CONDITIONS

Brief Title

Retraining and Control Therapy (ReACT)- Adults

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 19 years and older
  • Diagnosis of psychogenic non-epileptic seizures by a medical doctor using video-EEG
Not Eligible

You will not qualify if you...

  • Comorbid epilepsy
  • Fewer than 4 PNES episodes per month
  • Other paroxysmal nonepileptic events such as those related to hypoxic-ischemic phenomena, sleep disorders, or migraine-associated disorders
  • Participation in other therapy during the study
  • Severe intellectual disability
  • Severe mental illness including delusions or hallucinations
  • Blood pressure over 130/80 mmHg (exclusion for cold pressor test)

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Baseline Assessment and Randomization

Duration - 1 day

Participants complete baseline questionnaires, cognitive and symptom assessments, saliva collection, and wear a device to track sleep and seizure severity. Participants are then randomized to one of three groups with different waiting periods before therapy.

1 baseline visit (in-person) lasting about 2.5 hours

Waiting Period (if assigned)

Duration - 3 or 6 months depending on assignment

Participants assigned to the 3-month or 6-month waiting period log weekly seizures and may repeat some baseline measures before starting therapy.

Weekly logging of seizure episodes; 1 additional assessment visit before therapy start (if applicable)

Treatment

Duration - 12 weeks or as scheduled depending on waiting period

Participants receive 12 sessions of Retraining and Control Therapy (ReACT) via telehealth to manage seizures by targeting sense of control and symptom expectations.

12 telehealth therapy sessions; first session up to 2 hours, subsequent sessions 1 hour each

Post-Treatment Assessment

Duration - 1 day

One week after the final therapy session, participants complete follow-up cognitive tasks, questionnaires, and seizure assessments in the lab.

1 in-person visit lasting about 2 hours

Long-term Follow-up

Duration - 12 months

Participants complete three follow-up assessments via telehealth over the following year to monitor long-term seizure outcomes and quality of life.

3 telehealth visits at 2, 6, and 12 months after treatment; each lasting about 1 hour

Trial Site Locations

Total: 1 location

1

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

Actively Recruiting

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Research Team

A

Aaron Fobian, PhD

S

Stephanie Mueller, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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