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 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.

Is 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. ^{1 2 3 4 5}

How 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. ^{2 3 4 6 7}

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. ^{1 2 4 5 6}

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

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]

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]

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]

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]

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 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. United States 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. [2022]

2. United States 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. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

An evaluation of initial engagement with a virtual group-based psychological treatment for functional seizures. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Paediatricians' attitudes to and management of functional seizures in children. [2018]

5. United States 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. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Psychosocial and functional outcomes in young adults with childhood-onset epilepsy: a 10-year follow-up. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Social aspects of life in patients with functional (psychogenic nonepileptic) seizures: An international study. [2021]