Retraining and Control Therapy (ReACT) R33 Phase
ConditionConvulsion, Non-Epileptic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age11-18
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 pediatric psychogenic non-epileptic seizures (PNES, episodes resembling epileptic seizures but with no correlated epileptiform activity). 11-18-year-olds diagnosed with PNES will engage in twelve sessions of either ReACT or supportive therapy. 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 for Children (PCS-C), pain tolerance (time with hand in water) and cortisol response. Target assessments occur 7 days before treatment, 7 days after 12th treatment session, and 2 months after the 12th treatment session. Long term follow-up assessments will occur 6 months and 12 months after the 12th treatment session. PNES frequency will be measured from 30 days before to 12 months after treatment.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
11-18 years old.
Diagnosis of psychogenic non-epileptic seizures by a medical doctor using video-EEG.
Family member (parent/guardian if a minor) willing to participate and that the subject with PNES chooses.
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 adolescents to regain control of their body through managing thoughts and behaviors that reinforce the PNES and return to previous activities. It teaches parents how to respond to PNES in a manner that encourages the adolescents to regain control of their body. The PNES is explained as behaviors learned through classical and operant conditioning.
Supportive Therapy
BehavioralThe supportive therapy treatment consists of 12 sessions of therapy focused on discussing daily difficulties and/or stressors they experience and identifying stress triggers for PNES. The PNES is explained as physical manifestations of psychological stress.
Treatment groups
160 Participants
are divided into 3 treatment groupsGroup A: ReACT InterventionExperimental treatment 1 intervention
Group B: Supportive TherapyActive comparator 1 intervention
Group C: Healthy ControlNo intervention 0 interventions
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 (about 7 months total).
Time frame
7 months2
Pain catastrophizing scale for children- 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 (about 7 months total).
Time frame
7 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 (about 7 months total).
Time frame
7 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 (about 7 months total).
Time frame
7 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 treatment to 12 months after the 12th treatment session (about 16 months total).
Time frame
16 months2
Pain Catastrophizing Scale for Children (PCS-C)- 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 (about 7 months total).
Time frame
7 months3
Children's Somatic Symptoms Inventory (CSSI-24)
General somatic symptom complaints, higher scores indicate greater somatic complaints. Scores range from 0-140. Completed by participant and parent. Assessed at baseline visit, and 1 week, 2 months, 6 months and 12 months after the final therapy sessions (about 16 months total).
Time frame
16 months4
Anxiety Sensitivity Index (ASI)
Assesses catastrophic symptom expectations; scores ranges from 0-64, higher scores indicate greater anxiety. Completed by participant and parent. Assessed at baseline visit, and 1 week, 2 months, 6 months and 12 months after the final therapy sessions (about 16 months total).
Time frame
16 monthsSponsors 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