ReACT for Functional Seizures

Overseen By Aaron Fobian, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Epilepsy, Intellectual disability, Severe mental illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 12 weeks

108 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two therapy approaches to help young people with functional seizures, which resemble epileptic seizures but lack a neurological cause. Participants will receive either Retraining and Control Therapy (ReACT), which focuses on managing seizures through a therapist-guided plan, or the CATCH-IT program (Competent Adulthood Transition with Cognitive Behavioral, Humanistic, and Interpersonal Training), which uses online cognitive behavioral training with family involvement. The trial aims to assess the feasibility of a larger study to determine which treatment is more effective. It seeks participants aged 11-18 who have functional seizures and internet access for telehealth sessions.

As an unphased trial, this study offers participants the chance to contribute to pioneering research that could shape future treatment options for functional seizures.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both the ReACT and CATCH-IT treatments are generally easy for patients to handle. ReACT improves symptoms in children and teens with functional seizures, with no significant reports of serious side effects, suggesting it is a safe option for many patients.

CATCH-IT, an online therapy, has been studied for its effectiveness in mental health issues like depression. These studies also report it as safe, with no major negative effects. Participants usually manage it well, making it a reliable choice.

Overall, various studies have demonstrated that both treatments are safe and well-tolerated, which is encouraging for those considering joining this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ReACT and CATCH-IT interventions for functional seizures because they take a unique approach compared to traditional treatments, which often involve medication. ReACT stands out by providing a structured therapy plan with personalized sessions that focus on retraining the brain to manage seizures differently, using a hands-on approach with a therapist. Meanwhile, CATCH-IT offers an innovative web-based program that incorporates cognitive behavioral therapy (CBT) modules, engaging both the parent and child in the process. This dual approach not only aims to address the psychological aspects of functional seizures but also empowers participants with practical skills to manage their symptoms effectively.

What evidence suggests that this trial's treatments could be effective for functional seizures?

Research has shown that Retraining and Control Therapy (ReACT), one of the treatments in this trial, may help treat functional seizures in children. Specifically, studies found that children who received ReACT experienced fewer seizures. This therapy teaches them new ways to think about and respond to their symptoms, which appears effective.

Regarding the CATCH-IT treatment, another option in this trial, research suggests it can support mental health through online cognitive-behavioral strategies. While it primarily aims to prevent depression, it might also help manage functional seizures by enhancing emotional well-being and coping skills. Both treatments are under study in this trial for their potential to aid young people with functional seizures. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

I have a severe intellectual disability.

You are currently receiving other treatment.

You have severe mental illness with active delusions or hallucinations.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• CATCH-IT
• ReACT

Trial Overview 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.

How Is the Trial Designed?

Group I: ReACT Intervention Experimental Treatment 1 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 Intervention Active Control 1 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.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Yale University

Collaborator

Trials

1,963

Recruited

3,046,000+

Baylor College of Medicine

Collaborator

Trials

1,044

Recruited

6,031,000+

Published Research Related to This Trial

Young adults with uncomplicated childhood-onset epilepsy (COE) show poorer functional outcomes, particularly in cognition and overall disability, compared to population norm controls, despite having similar psychosocial outcomes after 10 years.

Baseline comorbidities such as attention-deficit/hyperactivity disorder (ADHD) and academic problems significantly contribute to these functional limitations, indicating that early identification of these issues is crucial for long-term management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychosocial and functional outcomes in young adults with childhood-onset epilepsy: a 10-year follow-up. Friefeld Kesselmayer, R., McMillan, T., Lee, B., et al.[2021]

In a study of 64 patients with functional seizures, 60.1% disengaged from an online CBT-based group treatment before the first session, highlighting a significant challenge in patient engagement.

Older patients were more likely to engage in the treatment, while those who disengaged cited barriers such as timing and format, preferring individual and in-person interventions, suggesting a need for tailored approaches to improve treatment access.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of initial engagement with a virtual group-based psychological treatment for functional seizures. Jones, A., Esteban-Serna, C., Proctor, BJ., et al.[2021]

A survey of 61 Danish paediatricians revealed that most believe functional seizures (FS) have a psychogenic cause, and many feel confident in diagnosing FS based solely on observation, highlighting a need for better training and understanding of the condition.

There is a strong demand for clinical guidelines among paediatricians, as only 13% find current treatment options adequate, and collaboration with child and adolescent mental health services (CAMHS) is seen as essential for effective management, though only 23% frequently refer patients to CAMHS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paediatricians' attitudes to and management of functional seizures in children. Nielsen, ES., Wichaidit, BT., Østergaard, JR., et al.[2018]

Psychological therapies are effective in improving non-seizure outcomes for adults with functional/dissociative seizures (FDSs), showing a moderate effect size of d = 0.51 based on a meta-analysis of 32 studies involving 898 participants.

Behavioral treatments, in particular, were found to be especially effective, leading to greater improvements in general functioning and overall well-being beyond just reducing seizure frequency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A meta-analytic review of the effectiveness of psychological treatment of functional/dissociative seizures on non-seizure outcomes in adults. Gaskell, C., Power, N., Novakova, B., et al.[2023]

The Retraining and Control Therapy (ReACT) significantly improved the sense of control in children with functional seizures (FS), which correlated with a reduction in seizure frequency, suggesting that enhancing control may be a key mechanism in treating FS.

After 60 days of ReACT, children showed significant improvements in selective attention and cognitive inhibition, along with reduced somatic symptoms, indicating that ReACT not only addresses FS but also positively impacts broader psychosocial factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sense of control, selective attention, cognitive inhibition, and psychosocial outcomes after Retraining and Control Therapy (ReACT) in pediatric functional seizures. Stager, L., Mueller, C., Morriss, S., et al.[2023]

A study involving 14 children with functional seizures showed that one year after completing Retraining and Control Therapy (ReACT), the frequency of seizures significantly decreased from an average of 5.62 seizures per week to 0.15, indicating long-term effectiveness of the treatment.

Both children and their parents reported that ReACT was helpful, supporting the idea that directly targeting functional seizures is more effective than focusing on mood or stress-related factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-year follow-up of treatment outcomes and patient opinions of Retraining and Control Therapy (ReACT) for pediatric functional seizures. Stager, L., Szaflarski, JP., Fobian, AD.[2022]

In a study of 440 patients with functional seizures from seven countries, only 33% were employed and 28% were able to drive, indicating significant social challenges faced by these individuals.

Patients with higher education levels were more likely to report a history of sexual abuse, and those without loss of responsiveness during seizures had better employment outcomes, highlighting the complex interplay between education, social history, and functional seizures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social aspects of life in patients with functional (psychogenic nonepileptic) seizures: An international study. Asadi-Pooya, AA., Alsaadi, T., Gigineishvili, D., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05819268

Study Details | NCT05819268 | A Multi-site Feasibility ... Diagnosis of functional seizures; Internet access for telehealth sessions and CATCH-IT. Exclusion Criteria: Comorbid epilepsy; Less than 4 functional seizures ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6286074/

Effect of Internet-Based Cognitive Behavioral Humanistic and ... CATCH-IT indicates competent adulthood transition with cognitive behavioral humanistic and interpersonal training; CES-D10, Center for ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/24800110/

Pilot Study of Implementation of an Internet-Based Depression ... Objective: To explore the implementation of CATCH-IT (Competent Adulthood Transition with Cognitive-behavioral Humanistic and Interpersonal Training), an ...

4. withpower.com withpower.com/trial/phase-seizures-4-2023-617f0

ReACT for Functional Seizures ... functional/dissociative seizures on non-seizure outcomes in adults. [2023]. 3 ... Cognitive Intervention for Epilepsy · Robotic Exoskeleton Therapy for ...

5. patlynk.com patlynk.com/trial/NCT00152529

C.A.T.C.H.-I.T.Competent Adulthood Transition With ... The purpose of this study is to adapt depression prevention interventions of proven benefit to the primary care setting in a manner that would be acceptable ...

6. trial.medpath.com trial.medpath.com/clinical-trial/da4015824e1c2b0e/nct00152529-catch-it-competent-adulthood-transition

C.A.T.C.H.-I.T.Competent Adulthood Transition With Cognitive ... The purpose of this study is to adapt depression prevention interventions of proven benefit to the primary care setting in a manner that would be...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10839524/

Internet-based cognitive behavioral therapy intervention for ... This study aims to assess the efficacy of Competent Adulthood Transition with Cognitive Humanistic and Interpersonal Teaching (CATCH-IT), an internet-based ...

8. medrxiv.org medrxiv.org/content/10.1101/2024.05.10.24307189v1.full.pdf

Cognitive Behavioural Therapy in Adults with Psychogenic ... functional seizures OR pseudoseizures OR pseudo seizures OR non epileptic attack disorder) and the intervention (psychotherapeutic Treatment ...