Retraining and Control Therapy (ReACT)- Adults
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.
- Who it may be relevant to
- Registry conditions: Convulsion, Non-Epileptic. Basic parameters: from 19 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 →
Unsure about the terms? Read our patient guide →
Official title
Retraining and Control Therapy (ReACT): Sense of Control and Catastrophic Symptom Expectations as Targets of a Cognitive Behavioral Treatment for Adult Functional Seizures (FS)
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 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.
Detailed description
Patients with PNES who are treated at the UAB FND clinic will have the option to complete additional study procedures. Participants will come to our laboratory for a baseline visit and 4 follow-up visits. After the baseline visit, participants are randomly assigned to one of three conditions: no wait, 3-month waiting period, 6-month waiting period. After the assigned waiting period participants will receive 12 sessions of Retraining and Control Therapy (ReACT) as usual in the FND clinic. Therapy sessions are completed via telehealth.
During the baseline visit, participants complete several questionnaires assessing demographics, mood and suicidality, relationships with friends and family, as well as past and current PNES symptoms. They will 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 and cortisol response to the CPT, respectively. PNES diaries are completed to assess PNES frequency over the previous 30 days. Participants randomized to the 3-month or 6-month waiting period conditions will log weekly PNES episodes until the start of therapy. Participants will also complete the Flanker Inhibitory Control and Attention, List Sorting Working Memory, Pattern Comparison Processing Speed, Dimensional Change Card Sort, and Picture Sequence Memory subtests. 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 following the baseline visit. 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.
After the baseline visit, participants are scheduled for the first of their 12 intervention sessions of ReACT depending on the waiting period they are assigned to. This first session lasts a maximum of two hours, and the following 11 sessions are scheduled weekly and last one hour. All 12 therapy sessions are conducted as telehealth visits via HIPAA-compliant platform. Participants will be mailed another Respironics Actiwatch Spectrum Pro before the 12th therapy session to track sleep and PNES episode severity and frequency for the 1 weeks between the 12th therapy session and the lab visit one week after the 12th treatment session.
Follow-up at 7 days after treatment 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. Participcants will complete 3 follow-up visits via Zoom at 2 months, 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 participant.
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 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.
Primary outcome measures
- Magic and turbulence task [Time frame: 6-12 months]
- Pain catastrophizing scale- situation specific [Time frame: 6-12 months]
- Pain tolerance (time) [Time frame: 6-12 months]
- Salivary Cortisol [Time frame: 6-12 months]
- Pain Rating Scale [Time frame: 6-12 months]
- Stroop task [Time frame: 6-12 months]
Secondary outcome measures (12)
- PNES Frequency [Time frame: 16-22 months]
- Pain Catastrophizing Scale (PCS)- General [Time frame: 6-12 months]
- Anxiety Sensitivity Index (ASI) [Time frame: 16-22 months]
- Shipley [Time frame: At Baseline]
- Quality of Life in Epilepsy (QOLIE-31) [Time frame: 16-22 months]
- Sense of Agency Question [Time frame: 16-22 months]
- LEVEL 2-Somatic Symptom report adapted from the Participant Health Questionnaire [Time frame: 16-22 months]
- WHO Disability Assessment Schedule (WHODAS2.0) [Time frame: 16-22 months]
- The Impact on Family Scale [Time frame: 16-22 months]
- Childhood Trauma Questionnaire [Time frame: At baseline]
- Hospital Anxiety and Depression Scale (HADS) [Time frame: 16-22 months]
- The Columbia Suicide Severity Rating Scale (C-SSRS) [Time frame: 16-22 months]
Eligibility criteria
Inclusion criteria
- 19 years and older.
- Diagnosis of psychogenic non-epileptic seizures by a medical doctor using video-EEG.
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
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: NCT06570954 · IRB-300013382 · R61MH127155