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

NCT05096273 | Recruiting DMC

• 2 other identifiers: IRB-151001004-2R61MH127155
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Convulsion, Non-Epileptic

Outcome Measures

Primary Outcomes (6)

• Magic and turbulence task

  Measure of perceived sense of control in response to tasks in which control is manipulated; Greater negative numbers indicate improved understanding of control. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).

  7 months

• Pain catastrophizing scale for children- situation specific

  Measures catastrophic symptom expectations; score ranges from 0-52, higher scores indicate greater levels of pain-related anxiety. Assessment done after performing Cold Pressor Test. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).

  7 months

• Pain tolerance (time)

  Measures catastrophic symptom expectations. Measured by the total time the participant can keep their hand in cool water during the Cold Pressor Test. Shorter time indicates less pain tolerance. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).

  7 months

• Salivary cortisol response to Cold Pressor Test

  Measures catastrophic symptom expectations. Measured before and after the cold pressor test. Increased cortisol response indicate increased perceived pain severity. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).

  7 months

• Pain Rating Scale

  Measures perceived pain severity after the CPT; score ranges from 0-100. Higher scores indicate greater perceived pain severity. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).

  7 months

• Stroop task

  Measure of cognitive inhibition and selective attention, higher scores means poorer cognitive inhibition and selective attention. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).

  7 months

Secondary Outcomes (30)

• PNES Frequency

  16 months

• Pain Catastrophizing Scale for Children (PCS-C)- General

  16 months

• Children's Somatic Symptoms Inventory (CSSI-24)

  16 months

• Anxiety Sensitivity Index (ASI)

  16 months

• Shipley

  At baseline

Study Arms (5)

CPT- Pain relief lotion

EXPERIMENTAL

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.

Behavioral: ReACT

CPT- Pain sensitivity lotion

EXPERIMENTAL

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.

Behavioral: ReACT

ReACT for PNES- Booster therapy sessions

ACTIVE COMPARATOR

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.

Behavioral: ReACT

ReACT for PNES- No Booster therapy sessions

EXPERIMENTAL

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

Behavioral: ReACT

Healthy Control

NO INTERVENTION

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.

Interventions

ReACT BEHAVIORAL

ReACT is a novel cognitive behavioral treatment and is a PNES intervention that targets sense of control and catastrophic symptom expectations

Also known as: Retraining and Control Therapy

CPT- Pain relief lotion; CPT- Pain sensitivity lotion; ReACT for PNES- Booster therapy sessions; ReACT for PNES- No Booster therapy sessions

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Sparks Center Office of Psychiatric Research

Birmingham, Alabama, 35294, United States

RECRUITING

MeSH Terms

Conditions

Seizures

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Aaron Fobian, PhD

CONTACT

205-934-2241; afobian@uabmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Researchers who conduct baseline and follow-up visits will be blinded to the condition (booster or no booster) to which the patient has been assigned. The statistician and data manger will be blinded to treatment condition when analyzing data. The PI and therapists will be blinded to participant's baseline target scores.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Children with PNES and matched controls will be prospectively enrolled.

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: October 27, 2021
• Study Start: October 28, 2021
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-08

Locations

US (1)