Treatment Outcomes of ReACT for PNES

NCT02801136 | Completed

• 1 other identifier: F151001004
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is examining the effects of Retraining and Control Therapy (ReACT; an intervention focused on changing behaviors and thoughts) for psychogenic non-epileptic seizures (PNES, episodes resembling epileptic seizures but with no medical explanation). Participants engage in 8 individual therapy sessions consisting of either cognitive behavioral therapy or supportive therapy. Healthy control participants also complete pre-questionnaires and two computer tasks.

Conditions

Convulsion, Non-Epileptic

Outcome Measures

Primary Outcomes (3)

• PNES Frequency

  Measured by Psychogenic Non-epileptic Seizures (PNES) diary including frequency, premonitory symptoms, description of PNES symptoms and duration. Assessed at baseline visit, 7 days after final therapy session, and 2 months after final therapy session (about 4 months total).

  14 months (4 months from baseline to 2 months after the final therapy session and then again for 30 days at the 1-year followup)

• Stroop Task

  Measure of cognitive inhibition and selective attention, higher scores means poorer cognitive inhibition and selective attention. Assessed at baseline visit, 7 days after final therapy session, and 2 months after final therapy session (about 4 months total).

  4 months

• 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, 7 days after final therapy session, and 2 months after final therapy session (about 4 months total).

  4 months

Secondary Outcomes (9)

• Coping Skills

  4 months

• Behavior Assessment System for Children, Second Edition

  4 months

• Pediatric Quality of Life Inventory Generic Core

  4 months

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

  4 months

• Childhood Trauma Questionnaire

  At baseline

Study Arms (3)

ReACT for PNES

EXPERIMENTAL

ReACT consists of 8 weekly 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 .

Behavioral: ReACT

Supportive Therapy

ACTIVE COMPARATOR

The supportive therapy treatment consists of 8 weekly 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.

Behavioral: Supportive Therapy

Healthy Control

NO INTERVENTION

Healthy controls are matched to patients with PNES based on age (+ or - 1 year), gender, race and family income. They come to one laboratory visit to complete initial visit questionnaires and computer tasks.

Interventions

ReACT BEHAVIORAL

Also known as: Retraining and Control Therapy

ReACT for PNES

Supportive Therapy BEHAVIORAL

Supportive Therapy

Eligibility Criteria

• Age: 9 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:

• Substance use.
• Psychosis.
• Severe intellectual disability
• Diagnosis of epilepsy is acceptable as long as patient's neurologist confirms that epileptic seizures are currently under control.
• Healthy controls are matched on age (+ or - 1 year), sex, race and family income and can have no psychiatric or medical diagnosis.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

Sparks Center Office of Psychiatric Research

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Seizures

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 11, 2016
• First Posted: June 15, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 7, 2022

Record last verified: 2022-03

Locations

US (1)