Retraining and Control Therapy (ReACT) R33 Phase
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ReACT, Supportive Therapy.
- Who it may be relevant to
- Registry conditions: Convulsion, Non-Epileptic. Basic parameters: 11 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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) - R33 Phase
Overview
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.
Detailed description
Participants with PNES and their parent come to our laboratory for a baseline visit and 4 follow-up visits. After the baseline visit, participants are randomized to 12 sessions of either Retraining and Control Therapy (ReACT) or supportive therapy. The first therapy session is in-person, and the following 11 sessions are completed via telehealth.
During the baseline visit, participants and their parent complete several questionnaires assessing demographics, mood and suicidality, relationships with friends and family, as well as past and current PNES symptoms. They also complete the childhood trauma questionnaire. The treatment targets (sense of control and catastrophic symptom expectations) are measured by the magic and turbulence computer task and pain tolerance, PCS-C and cortisol response to the CPT, respectively. PNES diaries are completed to assess PNES frequency over the previous 30 days. The baseline lab visit lasts about 2.5 hours. Saliva is collected over 1 time point before and 3 time points after the CPT to measure cortisol response to the CPT. Participants also collect 2 saliva samples 24 hours later to serve as a baseline outside of the laboratory setting. Participants will also be given a Respironics Actiwatch Spectrum Pro to track sleep and PNES episode severity and frequency for the 1 week between the baseline visit and first therapy session.
After the baseline visit, participants are scheduled to return in one week for their first of 12 intervention sessions of either ReACT or supportive therapy. This first session lasts a maximum of two hours, and the following 11 sessions are scheduled weekly and last one hour. The following 11 sessions are conducted as telehealth visits via HIPAA-compliant Zoom. Before beginning the first ReACT session, participants will complete the Flanker Inhibitory Control and Attention, List Sorting Working Memory, Pattern Comparison Processing Speed, Dimensional Change Card Sort, and Picture Sequence Memory subtests. Participants will be mailed another Respironics Actiwatch Spectrum Pro before the 11th therapy session to track sleep and PNES episode severity and frequency for the 2 weeks between the 11th therapy session and the lab visit one week after the 12th treatment session.
Follow-up at 7 days after treatment and 2 months after treatment also is conducted to perform tasks and complete follow-up assessment of the targets (sense of control and catastrophic symptom expectations), PNES frequency, and questionnaires. Each of these sessions last 2 hours. Participants will complete the Flanker Inhibitory Control and Attention, List Sorting Working Memory, Pattern Comparison Processing Speed, Dimensional Change Card Sort, and Picture Sequence Memory subtests at the lab visit at each of these visits. Participants will be mailed and asked to collect 2 saliva samples 1 day before they come in for their follow-up lab visit occuring 7 days after treatment. Participcants will complete 2 Zoom visits at 6 months and 12 months after treatment to assess long-term PNES outcomes and questionnaire data. These appointments will last 1 hour. PNES frequency will be measured from 30 days before treatment to 12 months after treatment through PNES diaries completed by the parent and the participant.
Participants will be offered the treatment to which they were not randomized after the 2-month follow-up when the study is completed.
After treatment, booster therapy sessions will be offered as needed.
Healthy controls will be recruited. Healthy controls and their parent come for a baseline laboratory visit and a follow up visit 13 weeks after the baseline visit. The baseline and follow-up appointments for healthy controls will be identical to the visits for children with PNES.
Interventions
- Behavioral ReACT
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 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 behavior - Behavioral Supportive Therapy
The 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.
Primary outcome measures
- Magic and turbulence task [Time frame: 7 months]
- Pain catastrophizing scale for children- situation specific [Time frame: 7 months]
- Pain tolerance (time) [Time frame: 7 months]
- Salivary Cortisol [Time frame: 7 months]
- Pain Rating Scale [Time frame: 7 months]
- Stroop task [Time frame: 7 months]
Secondary outcome measures (12)
- PNES Frequency [Time frame: 16 months]
- Pain Catastrophizing Scale for Children (PCS-C)- General [Time frame: 7 months]
- Children's Somatic Symptoms Inventory (CSSI-24) [Time frame: 16 months]
- Anxiety Sensitivity Index (ASI) [Time frame: 16 months]
- Shipley [Time frame: At Baseline]
- Quality of Life in Epilepsy for Adolescents (QOLIE-AD-48) [Time frame: 16 months]
- Sense of Agency Question [Time frame: 16 months]
- LEVEL 2-Somatic Symptom report adapted from the Participant Health Questionnaire [Time frame: 16 months]
- Functional Disability Inventory (FDI) [Time frame: 16 months]
- The Impact on Family Scale [Time frame: 16 months]
- Childhood Trauma Questionnaire [Time frame: At baseline]
- The Revised Children's Anxiety and Depression Scale (RCADS) [Time frame: 16 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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)
Exclusion for CPT:
- Blood pressure >130/80 mmHg for adolescents greater than or equal to 13 years old
- Either systolic and/or diastolic blood pressure greater than or equal to 95% based on sex and age for children less than 13 years old
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Alabama at Birmingham — Birmingham
Identifiers
NCT: NCT06007053 · IRB-151001004 · R33MH127155-03