ReACT for Functional Seizures
Recruiting in Palo Alto (17 mi)
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Alabama at Birmingham
Disqualifiers: Epilepsy, Intellectual disability, Severe mental illness, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial tests two treatments for young people aged 11-18 who experience seizures. One treatment involves therapy sessions to manage seizures, while the other uses online lessons and coaching to change behaviors. The goal is to see which method works better for these patients.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, it does exclude participants who are currently in other therapy, which might suggest some restrictions on concurrent treatments.
What data supports the effectiveness of the treatment CATCH-IT, Competent Adulthood Transition with Cognitive Behavioral, Humanistic, and Interpersonal Training, ReACT, Retraining and Control Therapy for functional seizures?
ReACT has been shown to be effective in improving pediatric functional seizures, with 82% of patients experiencing complete symptom remission at 60 days after treatment. Additionally, a study confirmed long-term maintenance of seizure reduction one year after ReACT, with children and parents reporting it as beneficial.
12345Is Retraining and Control Therapy (ReACT) safe for treating functional seizures?
The available research on Retraining and Control Therapy (ReACT) for pediatric functional seizures does not report any safety concerns, and both children and parents found the treatment beneficial.
13456How is the ReACT treatment for functional seizures different from other treatments?
ReACT is unique because it focuses on improving a patient's sense of control, cognitive inhibition (the ability to ignore distractions), and selective attention, which are not typically targeted in other treatments for functional seizures. This approach has shown promising results, with a high rate of symptom remission in pediatric patients.
23567Eligibility Criteria
This trial is for boys and girls aged 11-18 with a diagnosis of functional seizures. They must have internet access for telehealth sessions. Those with comorbid epilepsy, less than four seizures per month, severe intellectual disability, involvement in other therapies or severe mental illness are excluded.Inclusion Criteria
Internet access for telehealth sessions and CATCH-IT
I have been diagnosed with functional seizures.
I am between 11 and 18 years old.
Exclusion Criteria
I have a severe intellectual disability.
You are currently receiving other treatment.
You have severe mental illness with active delusions or hallucinations.
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
1 visit (phone call)
Baseline
Participants and their family member/caregiver complete questionnaires and receive a functional seizure diary
1 day
1 visit (in-person)
Treatment
Participants undergo 12 therapy sessions of either ReACT or CATCH-IT, with the first session in-person and the rest via telehealth
12 weeks
1 visit (in-person), 11 visits (virtual)
Follow-up
Participants are monitored for safety and effectiveness after treatment with follow-up visits
2 months
2 visits (virtual)
Long-term Follow-up
Participants have additional follow-up visits to assess long-term outcomes
12 months
2 visits (virtual)
Participant Groups
The study compares two treatments: Retraining and Control Therapy (ReACT) and CATCH-IT to see which helps manage pediatric functional seizures better. Participants will be randomly assigned to one of the treatments at three different sites over an 18-month period.
2Treatment groups
Experimental Treatment
Active Control
Group I: ReACT InterventionExperimental Treatment1 Intervention
During the initial visit participant will be randomized to either Retraining and Control Therapy (ReACT) or Competent Adulthood Transition with Cognitive Behavioral, Humanistic, and Interpersonal Training (CATCH-IT) intervention.
ReACT includes 12 sessions with a therapist that will discuss a plan for managing FS.
Participants will have 12 therapy sessions. The first session will be in-person which will last 2 hours and the subsequent 11 sessions will be conducted via video telehealth and each session will last 1 hour.
Group II: CATCH-IT InterventionActive Control1 Intervention
During the initial visit participant will be randomized to either Retraining and Control Therapy (ReACT) or Competent Adulthood Transition with Cognitive Behavioral, Humanistic, and Interpersonal Training (CATCH-IT) intervention.
CATCH-IT involves the parent and child completing CBT modules on the web-based CATCH-IT platform, and they will meet with a CATCH-IT coach 12 times to discuss the modules and plan how to apply this to their life and their FS.
Participants will have 12 therapy sessions. The first session will be in-person which will last 2 hours and the subsequent 11 sessions will be conducted via video telehealth and each session will last 1 hour.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Alabama at BirminghamBirmingham, AL
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Who Is Running the Clinical Trial?
University of Alabama at BirminghamLead Sponsor
Yale UniversityCollaborator
Baylor College of MedicineCollaborator
References
One-year follow-up of treatment outcomes and patient opinions of Retraining and Control Therapy (ReACT) for pediatric functional seizures. [2022]Retraining and Control Therapy (ReACT), a short-term treatment for pediatric functional seizures (FS), has been demonstrated to improve FS in children compared to supportive therapy. However, long-term maintenance of FS-reduction after ReACT is unclear. This study aims to assess seizure frequency 1 year after ReACT and determine patient and parents' opinions of ReACT. Children with functional seizures who previously completed ReACT and their parents were asked to report 30-day FS frequency 1 year after completing ReACT. They also reported if ReACT was helpful. Paired samples t-tests were used to compare FS frequency before ReACT to 1 year after and to compare FS frequency in 30 days after ReACT to 1 year after. Fourteen children (Meanage = 15.43) and their parents participated. Seven-day FS frequency for patients at 1-year follow-up (Mean = 0.15) was significantly lower than 7-day FS frequency pre-ReACT (Mean = 5.62; p = 0.005). No differences were found when comparing FS frequency during 30 days post-ReACT (Mean = 0.29) and in 30 days before 1-year follow-up (Mean = 0.71). This study confirms long-term maintenance of FS-reduction after ReACT and supports the efficacy of targeting FS directly as opposed to mood or stress for reducing FS. Additionally, children and parents believe ReACT is beneficial.
A meta-analytic review of the effectiveness of psychological treatment of functional/dissociative seizures on non-seizure outcomes in adults. [2023]Psychological therapies are considered the treatment of choice for functional/dissociative seizures (FDSs). Although most previous studies have focused on seizure persistence or frequency, it has been argued that well-being or health-related quality of life outcomes may actually be more meaningful. This study contributes by summarizing and meta-analyzing non-seizure outcomes to quantify the effectiveness of psychological treatment in this patient group. A pre-registered systematic search identified treatment studies (e.g., cohort studies, controlled trials) in FDSs. Data from these studies were synthesized using multi-variate random-effects meta-analysis. Moderators of treatment effect were examined using treatment characteristics, sample characteristics, and risk of bias. A total of 171 non-seizure outcomes across 32 studies with a pooled sample size of N = 898 yielded a pooled effect-size of d = .51 (moderate effect size). The outcome domain assessed and the type of psychological treatment were significant moderators of reported outcomes. Greater rates of improvement were demonstrated for outcomes assessing general functioning. Behavioral treatments emerged as particularly effective interventions. Psychological interventions are associated with clinical improvements across a broad array of non-seizure outcomes, over and above seizure frequency, in adults with FDSs.
An evaluation of initial engagement with a virtual group-based psychological treatment for functional seizures. [2021]Functional seizures are a common neurological presentation but access to evidence-based treatments is sporadic and often delayed. Patient engagement is an essential prerequisite to any treatment benefits, but previous research has not investigated engagement with psychological group treatments. In this service evaluation, we compared patients who initially engaged and disengaged from an online CBT-based group treatment on demographic and clinical variables, and illness-related beliefs. A self-report survey was used to explore reasons for disengagement. Of 64 patients invited to the group treatment, 39 (60.1%) disengaged before the first session. Older age was associated with engagement with the functional seizures group. There were no other group differences between demographic, clinical, or belief-based variables. Patients who disengaged reported the timing and format as barriers to joining and had preferences for individual and in-person interventions. These findings have implications for the role of clinicians in providing regular tangible information about referral pathways, and motivating patients to engage with available treatments.
Paediatricians' attitudes to and management of functional seizures in children. [2018]To explore paediatricians' attitudes to and treatment practice for children with functional seizures (FS).
Sense of control, selective attention, cognitive inhibition, and psychosocial outcomes after Retraining and Control Therapy (ReACT) in pediatric functional seizures. [2023]Differences in sense of control, cognitive inhibition, and selective attention in pediatric functional seizures (FS) versus matched controls implicate these as potential novel treatment targets. Retraining and Control Therapy (ReACT), which targets these factors, has been shown in a randomized controlled trial to be effective in improving pediatric FS with 82% of patients having complete symptom remission at 60 days following treatment. However, post-intervention data on sense of control, cognitive inhibition, and selective attention are not yet available. In this study, we assess changes in these and other psychosocial factors after ReACT.
Psychosocial and functional outcomes in young adults with childhood-onset epilepsy: a 10-year follow-up. [2021]To compare long-term psychosocial and functional outcomes of young adults with uncomplicated childhood-onset epilepsy (COE) to population norm controls utilizing a controlled prospective cohort study.
Social aspects of life in patients with functional (psychogenic nonepileptic) seizures: An international study. [2021]To explore various social aspects of life (i.e., employment, education, and driving) in a large sample of patients with functional seizures (FS) living in seven countries from four continents.