Treatment Outcomes of ReACT for PNES

Not Applicable

Completed

• Conditions: Convulsion, Non-Epileptic
• Interventions: Behavioral: ReACT; Behavioral: Supportive Therapy

• Registration Number: NCT02801136
• Lead Sponsor: University of Alabama at Birmingham

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.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-11
• Study First Submitted QC: 2016-06-11
• Study First Posted: 2016-06-15
• Primary Completion: 2021-12
• Study Completion: 2021-12
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-04
• Last Update Posted: 2022-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ReACT for PNES	ReACT	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 .
Supportive Therapy	Supportive Therapy	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.

Primary Outcome Measures

Name	Time	Method
PNES Frequency	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).
Stroop Task	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).
Magic and turbulence task	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 Outcome Measures

Name	Time	Method
Shipley	At baseline	Assesses verbal IQ; higher scores indicate greater verbal IQ
Coping Skills	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.
Behavior Assessment System for Children, Second Edition	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).
Pediatric Quality of Life Inventory Generic Core	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).
Children's Somatic Symptoms Inventory (CSSI-24)	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).
Childhood Trauma Questionnaire	At baseline	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)	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).
Millon Adolescent Clinical Inventory (MACI)	At baseline	Assesses mental health and behavior concerns in adolescents; higher scores indicate greater presence of subscale
Opinion of ReACT	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.

Trial Locations

Locations (1)

Sparks Center Office of Psychiatric Research; 🇺🇸 Birmingham, Alabama, United States