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Treatment Outcomes of ReACT for PNES

Primary Purpose

Convulsion, Non-Epileptic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ReACT
Supportive Therapy
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Convulsion, Non-Epileptic

Eligibility Criteria

9 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Sparks Center Office of Psychiatric Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

ReACT for PNES

Supportive Therapy

Healthy Control

Arm Description

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 .

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.

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.

Outcomes

Primary Outcome Measures

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).
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).
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).

Secondary Outcome Measures

Coping Skills
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.
Behavior Assessment System for Children, Second Edition
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).
Pediatric Quality of Life Inventory Generic Core
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).
Children's Somatic Symptoms Inventory (CSSI-24)
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).
Childhood Trauma Questionnaire
History of physical, sexual and/or emotional abuse and physical and emotional neglect, higher scores indicate greater abuse/neglect
Multidimensional Assessment of Interoceptive Awareness (MAIA)
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).
Millon Adolescent Clinical Inventory (MACI)
Assesses mental health and behavior concerns in adolescents; higher scores indicate greater presence of subscale
Shipley
Assesses verbal IQ; higher scores indicate greater verbal IQ
Opinion of ReACT
Parents and children are called and asked to independently report if they believed ReACT helpful and if so, what the most helpful part was.

Full Information

First Posted
June 11, 2016
Last Updated
March 4, 2022
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT02801136
Brief Title
Treatment Outcomes of ReACT for PNES
Official Title
Treatment Outcomes of Retraining and Control Therapy (ReACT) for Psychogenic Non-epileptic Seizures (PNES)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
December 2021 (Actual)
Study Completion Date
December 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Convulsion, Non-Epileptic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ReACT for PNES
Arm Type
Experimental
Arm Description
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 .
Arm Title
Supportive Therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Healthy Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
ReACT
Other Intervention Name(s)
Retraining and Control Therapy
Intervention Type
Behavioral
Intervention Name(s)
Supportive Therapy
Primary Outcome Measure Information:
Title
PNES Frequency
Description
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).
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)
Title
Stroop Task
Description
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).
Time Frame
4 months
Title
Magic and turbulence task
Description
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).
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Coping Skills
Description
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.
Time Frame
4 months
Title
Behavior Assessment System for Children, Second Edition
Description
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).
Time Frame
4 months
Title
Pediatric Quality of Life Inventory Generic Core
Description
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).
Time Frame
4 months
Title
Children's Somatic Symptoms Inventory (CSSI-24)
Description
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).
Time Frame
4 months
Title
Childhood Trauma Questionnaire
Description
History of physical, sexual and/or emotional abuse and physical and emotional neglect, higher scores indicate greater abuse/neglect
Time Frame
At baseline
Title
Multidimensional Assessment of Interoceptive Awareness (MAIA)
Description
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).
Time Frame
4 months
Title
Millon Adolescent Clinical Inventory (MACI)
Description
Assesses mental health and behavior concerns in adolescents; higher scores indicate greater presence of subscale
Time Frame
At baseline
Title
Shipley
Description
Assesses verbal IQ; higher scores indicate greater verbal IQ
Time Frame
At baseline
Title
Opinion of ReACT
Description
Parents and children are called and asked to independently report if they believed ReACT helpful and if so, what the most helpful part was.
Time Frame
12 months after the final therapy session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: 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.
Facility Information:
Facility Name
Sparks Center Office of Psychiatric Research
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Treatment Outcomes of ReACT for PNES

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