Treatment Outcomes of ReACT for PNES

Convulsion, Non-Epileptic Clinical Trial

Official title:

Treatment Outcomes of Retraining and Control Therapy (ReACT) for Psychogenic Non-epileptic Seizures (PNES)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02801136
• Other study ID #: F151001004
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: December 2021

Study information

• Verified date: March 2022
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Convulsion, Non-Epileptic
• Seizures

Intervention

Behavioral:
• ReACT

• Supportive Therapy

Locations

Country	Name	City	State
United States	Sparks Center Office of Psychiatric Research	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	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)
Primary	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).	4 months
Primary	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).	4 months
Secondary	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.	4 months
Secondary	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).	4 months
Secondary	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).	4 months
Secondary	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).	4 months
Secondary	Childhood Trauma Questionnaire	History of physical, sexual and/or emotional abuse and physical and emotional neglect, higher scores indicate greater abuse/neglect	At baseline
Secondary	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).	4 months
Secondary	Millon Adolescent Clinical Inventory (MACI)	Assesses mental health and behavior concerns in adolescents; higher scores indicate greater presence of subscale	At baseline
Secondary	Shipley	Assesses verbal IQ; higher scores indicate greater verbal IQ	At baseline
Secondary	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.	12 months after the final therapy session