Actively Recruiting

Phase Not Applicable
Age: 11Years - 18Years
All Genders
Healthy Volunteers
ID05096273

Retraining and Control Therapy (ReACT): Sense of Control and Catastrophic Symptom Expectations as Targets of a Cognitive Behavioral Treatment for Pediatric Psychogenic Non-epileptic Seizures (PNES)

Led by University of Alabama at Birmingham · Updated on 2025-09-03

68

Participants Needed

1

Research Sites

30 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 sense of control and catastrophic symptom expectations as key targets for Retraining and Control Therapy (ReACT), a cognitive behavioral treatment for children and adolescents aged 11 to 18 diagnosed with pediatric psychogenic non-epileptic seizures (PNES). PNES are episodes that resemble epileptic seizures but have no medical explanation. The study assesses these psychological factors to better understand and treat PNES. Healthy controls matched by age, gender, race, and family income also participate for comparison. Participants undergo a baseline laboratory visit with their parent, completing questionnaires on mood, relationships, trauma, and PNES symptoms. They perform the cold pressor test (CPT) twice, before and after applying either a pain relief or pain sensitivity lotion, to measure catastrophic symptom expectations. Participants then complete 12 weekly ReACT therapy sessions, mostly via telehealth, aimed at improving sense of control. After treatment, half receive two booster sessions at 3 and 9 months. Healthy controls have two similar visits for comparison. Throughout the study, participants complete tasks measuring cognitive functions and symptom tracking, including sleep and PNES frequency monitored by diaries and wearable devices. Follow-up visits occur one week after the 8th and 12th therapy sessions, with long-term follow-ups at 6 and 12 months via secure video calls. The study measures outcomes such as sense of control, pain tolerance, cortisol response, PNES frequency, and quality of life to understand the therapy's impact over time.

CONDITIONS

Brief Title

Retraining and Control Therapy (ReACT): Sense of Control and Symptom Expectations as Targets of a Treatment for PNES

Who Can Participate

Age: 11Years - 18Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 9 to 18 years old
  • Diagnosis of psychogenic non-epileptic seizures confirmed by video-EEG
  • Family member (parent if minor) willing to participate and chosen by the participant
Not Eligible

You will not qualify if you...

  • Diagnosis of comorbid epilepsy
  • Fewer than 4 PNES episodes per month
  • Other paroxysmal nonepileptic events such as hypoxic-ischemic episodes, sleep disorders, or migraine-associated disorders
  • Participation in other therapy
  • Severe intellectual disability
  • Severe mental illness involving delusions or hallucinations
  • Blood pressure over 130/80 mmHg for adolescents 13 years or older
  • Blood pressure greater than or equal to 95% percentile for sex and age in children under 13 years

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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 Visit

Duration - 1 day

Participants and their parent complete questionnaires, cognitive subtests, PNES diaries, saliva sampling for cortisol, and wear an Actiwatch to track sleep and PNES episodes before starting therapy.

1 visit (in-person, approximately 3 hours)

Treatment

Duration - 12 weeks

Participants complete 12 weekly ReACT therapy sessions targeting sense of control and catastrophic symptom expectations. The first session includes cognitive testing and lasts up to two hours; the following 11 sessions last one hour each, mostly conducted via telehealth. Actiwatch tracking occurs before the first session and again before the last session.

12 therapy sessions (1 in-person, 11 via telehealth)

Post-Treatment Assessments

Duration - 2 weeks

Participants return for two lab visits one week after the 8th and 12th therapy sessions to repeat baseline tasks and questionnaires to assess treatment effects.

2 visits (in-person)

Booster Therapy (for half of participants)

Duration - 6 months

Participants randomized to booster therapy receive 2 one-hour booster sessions at 3 months and 9 months after treatment to support maintenance of treatment gains.

2 sessions (timed at 3 and 9 months post-treatment, possibly telehealth)

Long-term Follow-up

Duration - 6 months

Participants complete follow-up visits at 6 and 12 months after treatment via Zoom to assess PNES frequency and questionnaire measures.

2 visits (remote via Zoom)

Trial Site Locations

Total: 1 location

1

Sparks Center Office of Psychiatric Research

Birmingham, Alabama, United States, 35294

Actively Recruiting

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Research Team

A

Aaron Fobian, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

5

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Published Research Related To This Trial

Retraining and control therapy: sense of control and catastrophic symptom expectations as targets of a cognitive behavioral treatment for pediatric functional seizures.

Caroline Watson, Badhma Valaiyapathi, Jerzy P Szaflarski...

https://pubmed.ncbi.nlm.nih.gov/41769205