Retraining and Control Therapy (ReACT)- Adults

NCT06570954 | Recruiting

• 2 other identifiers: IRB-300013382R61MH127155
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

ReACT

Outcome Measures

Primary Outcomes (6)

• Magic and turbulence task

  Measure of perceived sense of control in response to tasks in which control is manipulated; Greater negative numbers indicate improved understanding of control. Assessed at baseline visit, and 1 week and 2 months after the final therapy sessions.

  6-12 months

• Pain catastrophizing scale- situation specific

  Measures catastrophic symptom expectations; score ranges from 0-52, higher scores indicate greater levels of pain-related anxiety. Assessment done after performing Cold Pressor Test. Assessed at baseline visit, and 1 week and 2 months after the final therapy sessions.

  6-12 months

• Pain tolerance (time)

  Measures catastrophic symptom expectations. Measured by the total time the participant can keep their hand in cool water during the Cold Pressor Test. Shorter time indicates less pain tolerance. Assessed at baseline visit, and 1 week and 2 months after the final therapy sessions.

  6-12 months

• Salivary Cortisol

  Measures catastrophic symptom expectations. Measured before and after the cold pressor test. Increased cortisol response indicate increased perceived pain severity. Assessed at baseline visit, and 1 week and 2 months after the final therapy sessions.

  6-12 months

• Pain Rating Scale

  Measures perceived pain severity after the CPT; score ranges from 0-100. Higher scores indicate greater perceived pain severity. Assessed at baseline visit, and 1 week and 2 months after the final therapy sessions.

  6-12 months

• Stroop task

  Measure of cognitive inhibition and selective attention, higher scores means poorer cognitive inhibition and selective attention. Assessed at baseline visit, and 1 week and 2 months after the final therapy sessions.

  6-12 months

Secondary Outcomes (37)

• PNES Frequency

  16-22 months

• Pain Catastrophizing Scale (PCS)- General

  6-12 months

• Anxiety Sensitivity Index (ASI)

  16-22 months

• Shipley

  At Baseline

• Quality of Life in Epilepsy (QOLIE-31)

  16-22 months

Study Arms (3)

No waiting period

ACTIVE COMPARATOR

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

Behavioral: ReACT

3-month waiting period

ACTIVE COMPARATOR

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.

Behavioral: ReACT

6-month waiting period

ACTIVE COMPARATOR

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.

Behavioral: ReACT

Interventions

ReACT BEHAVIORAL

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.

Also known as: Retraining and Control Therapy

3-month waiting period; 6-month waiting period; No waiting period

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)
• Blood pressure \>130/80 mmHg

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

MeSH Terms

Conditions

Seizures

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Aaron Fobian, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aaron Fobian, PhD

CONTACT

205-934-2241; afobian@uabmc.edu

Stephanie Mueller, PhD

CONTACT

smueller@uabmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Researchers who conduct baseline and follow-up visits will be blinded to the condition to which the patient has been assigned. The statistician and data manger will be blinded to waiting period the patient got assigned to when analyzing data. The PI and therapists will be blinded to participant's baseline target scores.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants 19 years and older with PNES will be prospectively enrolled. Participants will be randomly assigned to one of three conditions: no wait, 3-month waiting period, 6-month waiting period after which they will receive 12 sessions of Retraining and Control Therapy (ReACT).

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: August 26, 2024
• Study Start: April 10, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 6, 2025

Record last verified: 2025-06

Locations

US (1)