Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- 19 years and older
- Diagnosis of psychogenic non-epileptic seizures by a medical doctor using video-EEG
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
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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)
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
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
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
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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