Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
94 participants
INTERVENTIONAL
2016-06-30
2021-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ReACT for PNES
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 .
ReACT
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.
Supportive Therapy
Healthy Control
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.
No interventions assigned to this group
Interventions
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ReACT
Supportive Therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
9 Years
18 Years
ALL
Yes
Sponsors
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University of Alabama at Birmingham
OTHER
Responsible Party
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Aaron Fobian
Principal investigator
Locations
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Sparks Center Office of Psychiatric Research
Birmingham, Alabama, United States
Countries
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Other Identifiers
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F151001004
Identifier Type: -
Identifier Source: org_study_id
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