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Completed

NCT Number: NCT02801136

Treatment Outcomes of ReACT for PNES

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.

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Key information

Conditions

Convulsion, Non-Epileptic Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms

Age range

9 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sparks Center Office of Psychiatric Research

Birmingham, Alabama, 35294, United States

About this study

Participants come to our laboratory for a total of 11 sessions. During the initial visit, participants complete several questionnaires assessing demographics, personality style, relationships with friends and family, as well as past and current PNES symptoms. They also completed two computer tasks: the magic and turbulence task and a modified Stroop task. Participants must provide EEG results indicating a diagnosis of psychogenic non-epileptic seizures.

Participants receive a PNES diary to record all episodes during the course of the study. They are randomly assigned to either receive ReACT for PNES or supportive therapy, and they return 8 times over the next 8 weeks for therapy sessions. If randomized to ReACT, participants and a family member learn how to change behaviors and thoughts to address PNES. If randomized to supportive therapy, they discuss stressors and how they relate to the PNES.

Procedures are the same for each therapy group. The first therapy session lasts approximately 90 minutes. All subsequent sessions last about one hour. After completing the 8 therapy sessions participants return one week later for a follow-up visit lasting approximately one hour. This visit consists of answering several questionnaires and an interview about current PNES symptoms. Participants return two months later for a final follow-up visit similar to the one week follow up visit. Lastly, participants and their parent are called 1 year after completing treatment and are asked to report PNES frequency over the last 30 days. They are also asked if they think ReACT was helpful, and if so, what the most helpful part of ReACT was.

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

ReACT

Behavioral

Other names: Retraining and Control Therapy

Supportive Therapy

Behavioral

Primary outcomes

  1. PNES Frequency

    Time frame: 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)

    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).

  2. Stroop Task

    Time frame: 4 months

    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).

  3. Magic and turbulence task

    Time frame: 4 months

    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).

Secondary outcomes

  1. Coping Skills

    Time frame: 4 months

    Adolescent Coping Orientation for Problem Experiences (A-Cope) will be assessed at baseline visit, 7 days after final therapy session, and 2 months after final therapy session (about 4 months total). Scores range from 54-270.

  2. Behavior Assessment System for Children, Second Edition

    Time frame: 4 months

    Anxiety, Depression, Social Stress, Somatization, Relations with Parents higher scores indicate greater anxiety and depression. Scores range from 0-100. Assessed at baseline visit, 7 days after final therapy session, and 2 months after final therapy session (about 4 months total).

  3. Pediatric Quality of Life Inventory Generic Core

    Time frame: 4 months

    Pediatric quality of life, greater scores indicate greater quality of life. Scores range from 0-100. Assessed at baseline visit, 7 days after final therapy session, and 2 months after final therapy session (about 4 months total).

  4. Children's Somatic Symptoms Inventory (CSSI-24)

    Time frame: 4 months

    general somatic symptom complaints, higher scores indicate greater somatic complaints. Scores range from 0-140. Assessed at baseline visit, 7 days after final therapy session, and 2 months after final therapy session (about 4 months total).

  5. Childhood Trauma Questionnaire

    Time frame: At baseline

    History of physical, sexual and/or emotional abuse and physical and emotional neglect, higher scores indicate greater abuse/neglect

  6. Multidimensional Assessment of Interoceptive Awareness (MAIA)

    Time frame: 4 months

    Measure of components of interoceptive awareness; higher scores indicate greater presence of interoceptive awareness. Assessed at baseline visit, 7 days after final therapy session, and 2 months after final therapy session (about 4 months total).

  7. Millon Adolescent Clinical Inventory (MACI)

    Time frame: At baseline

    Assesses mental health and behavior concerns in adolescents; higher scores indicate greater presence of subscale

  8. Shipley

    Time frame: At baseline

    Assesses verbal IQ; higher scores indicate greater verbal IQ

  9. Opinion of ReACT

    Time frame: 12 months after the final therapy session

    Parents and children are called and asked to independently report if they believed ReACT helpful and if so, what the most helpful part was.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

Treatment Outcomes of Retraining and Control Therapy (ReACT) for Psychogenic Non-epileptic Seizures (PNES)

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Jun 15, 2016
Registry last updated
Mar 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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