Retraining and Control Therapy (ReACT): Sense of Control and Symptom Expectations as Targets of a Treatment for PNES

NCT ID: NCT05096273

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-28
• Study Completion Date: 2026-12-31

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 medical explanation). 11-18-year-olds diagnosed with PNES will engage in twelve sessions of ReACT. 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 will occur 7 days before treatment, 7 days after 8th treatment session and 7 days after 12th treatment session. Participants will also complete long term follow-up visits via HIPAA-compliant Zoom at 6 months and 12 months after the 12th treatment session where participants will complete questionnaires. PNES frequency will be measured from 30 days before to 12 months after treatment.

Detailed Description

PNES participants and their parent come to our laboratory for a baseline visit, 2 follow-up visits and 12 therapy sessions. Participants will complete 2 long-term follow-up visits at 6 months and 12 months after the 12th treatment session via HIPAA-compliant Zoom. Half of the participants will be randomized to receive 2 booster therapy sessions after treatment. Participants must provide EEG results indicating a diagnosis of psychogenic non-epileptic seizures.

During the initial visit, participants and their parent will 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), will be measured by the magic and turbulence computer task and pain tolerance, PCS-C and cortisol response to the CPT, respectively. After completing the CPT, participants will be randomized to receive a pain relief lotion or a pain sensitivity lotion. Participants will then repeat the CPT with the lotion applied to their hand. PNES diaries will be completed to assess PNES frequency over the previous 30 days. The baseline lab visit will last about 3 hours. Saliva will be collected over 3 time points before and after each CPT to measure cortisol response to the CPT. Participants will 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 ReACT session.

All participants will then be scheduled to return in one week for their first of 12 sessions of ReACT. 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. This first session will last a maximum of two hours, and the following 11 sessions will be scheduled weekly and will each last one hour. The following 11 sessions are currently conducted via telehealth due to COVID-19. Participants will be mailed another Respironics Actiwatch Spectrum Pro before the 11th therapy session to track sleep and PENS episode severity and frequency for the 2 weeks between the 11th therapy session and the lab visit one week after the 12th treatment session.

To assess treatment dose, participants will return for post lab visits one week after the 8th treatment session and 12th treatment sessions to perform tasks and fill out questionnaires completed at baseline. Long-term follow-up at 6 months and 12 months after treatment will also be conducted to assess FS frequency and questionnaires. 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 after the 12th treatment session. Each of these sessions will last about 1 to 2 hours. 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.

After treatment, half of the participants will be randomized to receive 2 booster therapy sessions at 3 months and 9 months after the end of treatment. Each of these sessions will last one hour.

Healthy controls are matched to participants with PNES based on age (+ or - 1 year), gender, race and family income. 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

CPT- Pain relief lotion

During the initial visit participant will do the cold pressor test twice to assess catastrophic symptom expectations. After completing the 1st CPT, participants will be randomized to receive a pain relief lotion or pain sensitivity lotion. Participants will then repeat the CPT with the lotion applied to their hand.

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

CPT- Pain sensitivity lotion

During the initial visit participant will do the cold pressor test twice to assess catastrophic symptom expectation. After completing the 1st CPT, participants will be randomized to receive a pain relief lotion or pain sensitivity lotion. Participants will then repeat the CPT with the lotion applied to their hand.

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 for PNES- Booster therapy sessions

After completing the 12 therapy sessions, half of the participants will be randomized to receive 2 booster therapy sessions, 3 months and 9 months after the 12th ReACT treatment session.

Group Type: ACTIVE_COMPARATOR

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 for PNES- No Booster therapy sessions

After completing the 12 ReACT treatment sessions, half of the participants will be randomized to not receive the 2 booster therapy sessions.

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

Healthy Control

Healthy controls are matched to participants with PNES based on age (+ or - 1 year), gender, race and family income. 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

Intervention Type: BEHAVIORAL

Other Intervention Names

Retraining and Control Therapy

Eligibility Criteria

Inclusion Criteria

• 9-18 years old.
• Diagnosis of psychogenic non-epileptic seizures by a medical doctor using video-EEG.
• Family member (parent 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
• 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

Locations

Sparks Center Office of Psychiatric Research

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, MD

Role: primary

bvalaiyapathi@uabmc.edu

2059754205

Aaron Fobian, PhD

Role: backup

afobian@uab.edu

2059342241

Other Identifiers

R61MH127155

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-151001004-2

Identifier Type: -

Identifier Source: org_study_id