Clinical trial NCT02801136: 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
Overall status: COMPLETED
Phase: NA
Conditions: Convulsion, Non-Epileptic
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2016-06-15
Enrollment: 94
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: PNES Frequency
timeFrame: 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)
measure: Stroop Task
timeFrame: 4 months
measure: Magic and turbulence task
timeFrame: 4 months
Secondary outcomes:
measure: Coping Skills
timeFrame: 4 months
measure: Behavior Assessment System for Children, Second Edition
timeFrame: 4 months
measure: Pediatric Quality of Life Inventory Generic Core
timeFrame: 4 months
measure: Children's Somatic Symptoms Inventory (CSSI-24)
timeFrame: 4 months
measure: Childhood Trauma Questionnaire
timeFrame: At baseline
measure: Multidimensional Assessment of Interoceptive Awareness (MAIA)
timeFrame: 4 months
measure: Millon Adolescent Clinical Inventory (MACI)
timeFrame: At baseline
measure: Shipley
timeFrame: At baseline
measure: Opinion of ReACT
timeFrame: 12 months after the final therapy session
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Sparks Center Office of Psychiatric Research
state: Alabama
Study officials:
References: