Retraining and Control Therapy (ReACT)- Adults
ConditionConvulsion, Non-Epileptic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorUniversity of Alabama at Birmingham
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
19 years and older.
Diagnosis of psychogenic non-epileptic seizures by a medical doctor using video-EEG.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
ReACT
BehavioralReACT 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.
Treatment groups
50 Participants
are divided into 3 treatment groupsGroup A: No waiting periodActive comparator 1 intervention
Group B: 3-month waiting periodActive comparator 1 intervention
Group C: 6-month waiting periodActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
6-12 months2
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.
Time frame
6-12 months3
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.
Time frame
6-12 months4
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.
Time frame
6-12 monthsSecondary outcomes
1
PNES Frequency
Measured by Psychogenic Non-epileptic Seizures (PNES) diary, including frequency, premonitory symptoms, description of PNES symptoms and duration. Assessed 30 days before baseline visit to 12 months after the 12th treatment session.
Time frame
16-22 months2
Pain Catastrophizing Scale (PCS)- General
Measures catastrophic symptom expectations; score ranges from 0-52, higher scores indicate greater levels of pain-related anxiety. Assessment done before performing Cold Pressor Test. Assessed at baseline visit, and 1 week and 2 months after the final therapy sessions.
Time frame
6-12 months3
Anxiety Sensitivity Index (ASI)
Assesses catastrophic symptom expectations; scores ranges from 0-64, higher scores indicate greater anxiety. Completed by participant. Assessed at baseline visit, and 1 week, 2 months, 6 months and 12 months after the final therapy sessions.
Time frame
16-22 months4
Shipley
Assesses verbal IQ; higher scores indicate greater verbal IQ. Completed by participant. Assessed at baseline visit.
Time frame
At BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Alabama at Birmingham
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov