Retraining and Control Therapy (ReACT) R33 Phase

NCT ID: NCT06007053

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-09
• Study Completion Date: 2026-08-31

Brief Summary

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.

Conditions

Convulsion, Non-Epileptic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ReACT Intervention

At the end of the baseline visit, half of the participants will be randomized to receive Retraining and Control Therapy (ReACT)

Group Type: EXPERIMENTAL

ReACT

Intervention Type: BEHAVIORAL

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 behaviors learned through classical and operant conditioning.

Supportive Therapy

At the end of the baseline visit, half of the participants will be randomized to receive supportive therapy

Group Type: ACTIVE_COMPARATOR

Supportive Therapy

Intervention Type: BEHAVIORAL

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.

Healthy Control

Healthy controls are ages 12-18 with no significant comorbid medical or mental health conditions. Healthy controls and their parent come for 1 baseline laboratory visit and a follow up visit 13 weeks after the baseline visit. These visits will be identical to baseline and follow-up visits of children with PNES.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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 behaviors learned through classical and operant conditioning.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Retraining and Control Therapy

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

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Aaron Fobian

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aaron Fobian, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Aaron Fobian, PhD

Role: CONTACT

afobian@uabmc.edu

205-934-2241

Facility Contacts

Badhma Valaiyapathi, MBBS, MPH

Role: primary

drbadhma@uab.edu

205-975-4205

Other Identifiers

IRB-151001004

Identifier Type: -

Identifier Source: org_study_id