- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02801136
Treatment Outcomes of ReACT for PNES
Treatment Outcomes of Retraining and Control Therapy (ReACT) for Psychogenic Non-epileptic Seizures (PNES)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35294
- Sparks Center Office of Psychiatric Research
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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 .
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Other Names:
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Active Comparator: 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.
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No Intervention: 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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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).
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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)
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Stroop Task
Time Frame: 4 months
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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).
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4 months
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Magic and turbulence task
Time Frame: 4 months
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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).
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4 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Coping Skills
Time Frame: 4 months
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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.
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4 months
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Behavior Assessment System for Children, Second Edition
Time Frame: 4 months
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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).
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4 months
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Pediatric Quality of Life Inventory Generic Core
Time Frame: 4 months
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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).
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4 months
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Children's Somatic Symptoms Inventory (CSSI-24)
Time Frame: 4 months
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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).
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4 months
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Childhood Trauma Questionnaire
Time Frame: At baseline
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History of physical, sexual and/or emotional abuse and physical and emotional neglect, higher scores indicate greater abuse/neglect
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At baseline
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Multidimensional Assessment of Interoceptive Awareness (MAIA)
Time Frame: 4 months
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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).
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4 months
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Millon Adolescent Clinical Inventory (MACI)
Time Frame: At baseline
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Assesses mental health and behavior concerns in adolescents; higher scores indicate greater presence of subscale
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At baseline
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Shipley
Time Frame: At baseline
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Assesses verbal IQ; higher scores indicate greater verbal IQ
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At baseline
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Opinion of ReACT
Time Frame: 12 months after the final therapy session
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Parents and children are called and asked to independently report if they believed ReACT helpful and if so, what the most helpful part was.
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12 months after the final therapy session
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- F151001004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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