Convulsion, Non-EpilepticReACTNCT06007053
Retraining and Control Therapy (ReACT) R33 Phase
A study testing ReACT and Supportive Therapy in people with Convulsion, Non-Epileptic, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this study is to assess sense of control and catastrophic symptom expectations as targets for Retraining and Control Therapy (ReACT- an intervention focused on changing behaviors and thoughts) for treatment of pediatric psychogenic non-epileptic seizures (PNES, episodes resembling epileptic seizures but… Read more about this study
- Who is it for?
- Ages 11 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Convulsion, Non-Epileptic
- What is being tested?
- ReACT and Supportive Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 11-18 years old.
- Diagnosis of psychogenic non-epileptic seizures by a medical doctor using video-EEG.
- Family member (parent/guardian if a minor) willing to participate and that the subject with PNES chooses.
Who cannot join
- Comorbid Epilepsy
- Less than 4 PNES per month
- Other paroxysmal nonepileptic events (e.g. episodes related to hypoxic-ischemic phenomena, sleep disorders or migraine-associated disorders)
- Participation in other therapy during the study
- Severe intellectual disability
- Severe mental illness (delusions/hallucinations)
- Blood pressure >130/80 mmHg for adolescents greater than or equal to 13 years old
- Either systolic and/or diastolic blood pressure greater than or equal to 95% based on sex and age for children less than 13 years old
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Badhma Valaiyapathi, MBBS, MPH, 205-975-4205, drbadhma@uab.edu
About this study
Official title: Retraining and Control Therapy (ReACT): Sense of Control and Catastrophic Symptom Expectations as Targets of a Cognitive Behavioral Treatment for Pediatric Psychogenic Non-epileptic Seizures (PNES) - R33 Phase
The purpose of this study is to assess sense of control and catastrophic symptom expectations as targets for Retraining and Control Therapy (ReACT- an intervention focused on changing behaviors and thoughts) for treatment of pediatric psychogenic non-epileptic seizures (PNES, episodes resembling epileptic seizures but with no correlated epileptiform activity). 11-18-year-olds diagnosed with PNES will engage in twelve sessions of either ReACT or supportive therapy. Sense of control over actions will be measured by the magic and turbulence task, a well-validated measure of sense of control. Participants will complete the cold pressor test (CPT) in which participants hold their hand in cool water for as long as possible up to 3 minutes. Catastrophic symptom expectations in response to the CPT will be measured by Pain Catastrophizing Scale for Children (PCS-C), pain tolerance (time with hand in water) and cortisol response. Target assessments occur 7 days before treatment, 7 days after 12th treatment session, and 2 months after the 12th treatment session. Long term follow-up assessments will occur 6 months and 12 months after the 12th treatment session. PNES frequency will be measured from 30 days before to 12 months after treatment.
Read the detailed description
Participants with PNES and their parent come to our laboratory for a baseline visit and 4 follow-up visits. After the baseline visit, participants are randomized to 12 sessions of either Retraining and Control Therapy (ReACT) or supportive therapy. The first therapy session is in-person, and the following 11 sessions are completed via telehealth.
During the baseline visit, participants and their parent complete several questionnaires assessing demographics, mood and suicidality, relationships with friends and family, as well as past and current PNES symptoms. They also complete the childhood trauma questionnaire. The treatment targets (sense of control and catastrophic symptom expectations) are measured by the magic and turbulence computer task and pain tolerance, PCS-C and cortisol response to the CPT, respectively. PNES diaries are completed to assess PNES frequency over the previous 30 days. The baseline lab visit lasts about 2.5 hours. Saliva is collected over 1 time point before and 3 time points after the CPT to measure cortisol response to the CPT. Participants also collect 2 saliva samples 24 hours later to serve as a baseline outside of the laboratory setting. Participants will also be given a Respironics Actiwatch Spectrum Pro to track sleep and PNES episode severity and frequency for the 1 week between the baseline visit and first therapy session.
After the baseline visit, participants are scheduled to return in one week for their first of 12 intervention sessions of either ReACT or supportive therapy. This first session lasts a maximum of two hours, and the following 11 sessions are scheduled weekly and last one hour. The following 11 sessions are conducted as telehealth visits via HIPAA-compliant Zoom. Before beginning the first ReACT session, participants will complete the Flanker Inhibitory Control and Attention, List Sorting Working Memory, Pattern Comparison Processing Speed, Dimensional Change Card Sort, and Picture Sequence Memory subtests. Participants will be mailed another Respironics Actiwatch Spectrum Pro before the 11th therapy session to track sleep and PNES episode severity and frequency for the 2 weeks between the 11th therapy session and the lab visit one week after the 12th treatment session.
Follow-up at 7 days after treatment and 2 months after treatment also is conducted to perform tasks and complete follow-up assessment of the targets (sense of control and catastrophic symptom expectations), PNES frequency, and questionnaires. Each of these sessions last 2 hours. Participants will complete the Flanker Inhibitory Control and Attention, List Sorting Working Memory, Pattern Comparison Processing Speed, Dimensional Change Card Sort, and Picture Sequence Memory subtests at the lab visit at each of these visits. Participants will be mailed and asked to collect 2 saliva samples 1 day before they come in for their follow-up lab visit occuring 7 days after treatment. Participcants will complete 2 Zoom visits at 6 months and 12 months after treatment to assess long-term PNES outcomes and questionnaire data. These appointments will last 1 hour. PNES frequency will be measured from 30 days before treatment to 12 months after treatment through PNES diaries completed by the parent and the participant.
Participants will be offered the treatment to which they were not randomized after the 2-month follow-up when the study is completed.
After treatment, booster therapy sessions will be offered as needed.
Healthy controls will be recruited. Healthy controls and their parent come for a baseline laboratory visit and a follow up visit 13 weeks after the baseline visit. The baseline and follow-up appointments for healthy controls will be identical to the visits for children with PNES.
- Conditions
- Convulsion, Non-Epileptic
- Being tested
- ReACT, Supportive Therapy
- Keywords
- Supportive therapy, ReACT
- Medical subject headings
- Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReACTBehavioural
Also called Retraining and Control Therapy
ReACT is a novel cognitive behavioral treatment and is a PNES intervention that targets sense of control and catastrophic symptom expectations. ReACT consists of 12 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 TherapyBehavioural
The supportive therapy treatment consists of 12 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.
| Study group | Role | What they receive |
|---|---|---|
| ReACT Intervention | Experimental | At the end of the baseline visit, half of the participants will be randomized to receive Retraining and Control Therapy (ReACT) Receives: Behavioral: ReACT |
| Supportive Therapy | Active comparator | At the end of the baseline visit, half of the participants will be randomized to receive supportive therapy Receives: Behavioral: Supportive Therapy |
| Healthy Control | No intervention | Healthy controls are ages 12-18 with no significant comorbid medical or mental health conditions. Healthy controls and their parent come for 1 baseline laboratory visit and a follow up visit 13 weeks after the baseline visit. These visits will be identical to baseline and follow-up visits of children with PNES. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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, and 1 week and 2 months after the final therapy sessions (about 7 months total).
Measured: 7 months
Pain catastrophizing scale for children- situation specific
Measures catastrophic symptom expectations; score ranges from 0-52, higher scores indicate greater levels of pain-related anxiety. Assessment done after performing Cold Pressor Test. Assessed at baseline visit, and 1 week and 2 months after the final therapy sessions (about 7 months total).
Measured: 7 months
Pain tolerance (time)
Measures catastrophic symptom expectations. Measured by the total time the participant can keep their hand in cool water during the Cold Pressor Test. Shorter time indicates less pain tolerance. Assessed at baseline visit, and 1 week and 2 months after the final therapy sessions (about 7 months total).
Measured: 7 months
Salivary Cortisol
Measures catastrophic symptom expectations. Measured before and after the cold pressor test. Increased cortisol response indicate increased perceived pain severity. Assessed at baseline visit, and 1 week and 2 months after the final therapy sessions (about 7 months total).
Measured: 7 months
Pain Rating Scale
Measures perceived pain severity after the CPT; score ranges from 0-100. Higher scores indicate greater perceived pain severity. Assessed at baseline visit, and 1 week and 2 months after the final therapy sessions (about 7 months total).
Measured: 7 months
Stroop task
Measure of cognitive inhibition and selective attention, higher scores means poorer cognitive inhibition and selective attention. Assessed at baseline visit, and 1 week and 2 months after the final therapy sessions (about 7 months total).
Measured: 7 months
Secondary outcomes (39)
PNES Frequency
Measured by Psychogenic Non-epileptic Seizures (PNES) diary, including frequency, premonitory symptoms, description of PNES symptoms and duration. Assessed 30 days before treatment to 12 months after the 12th treatment session (about 16 months total).
Measured: 16 months
Pain Catastrophizing Scale for Children (PCS-C)- General
Measures catastrophic symptom expectations; score ranges from 0-52, higher scores indicate greater levels of pain-related anxiety. Assessment done before performing Cold Pressor Test. Assessed at baseline visit, and 1 week and 2 months after the final therapy sessions (about 7 months total).
Measured: 7 months
Children's Somatic Symptoms Inventory (CSSI-24)
General somatic symptom complaints, higher scores indicate greater somatic complaints. Scores range from 0-140. Completed by participant and parent. Assessed at baseline visit, and 1 week, 2 months, 6 months and 12 months after the final therapy sessions (about 16 months total).
Measured: 16 months
Anxiety Sensitivity Index (ASI)
Assesses catastrophic symptom expectations; scores ranges from 0-64, higher scores indicate greater anxiety. Completed by participant and parent. Assessed at baseline visit, and 1 week, 2 months, 6 months and 12 months after the final therapy sessions (about 16 months total).
Measured: 16 months
Shipley
Assesses verbal IQ; higher scores indicate greater verbal IQ. Completed by participant. Assessed at baseline visit.
Measured: At Baseline
Quality of Life in Epilepsy for Adolescents (QOLIE-AD-48)
Assesses health-related quality of life for children with epilepsy (used in PNES participants by instructing them to consider their PNES when asked about "seizures"); score ranges from 0-100, higher scores indicate better functioning and well-being. Completed by participant. Assessed at baseline visit, and 1 week, 2 months, 6 months and 12 months after the final therapy sessions (about 16 months total).
Measured: 16 months
Sense of Agency Question
Single question which asks "How much control do you believe you have over your PNES?", scored using a 4-point Likert scale. Lower score indicates better control over PNES. Completed by participant. Assessed at baseline visit, and 1 week, 2 months, 6 months and 12 months after the final therapy sessions (about 16 months total).
Measured: 16 months
LEVEL 2-Somatic Symptom report adapted from the Participant Health Questionnaire
Measures symptom severity in children; scores ranges from 0-26, higher scores indicate greater symptom severity. Completed by participant and parent. Assessed at baseline visit, and 1 week, 2 months, 6 months and 12 months after the final therapy sessions (about 16 months total).
Measured: 16 months
Functional Disability Inventory (FDI)
Completed by child and parent to measure physical functioning and disability in children with chronic pain; score ranges from 0-60, higher scores indicate greater perceived functional disability. Completed by participant and parent. Assessed at baseline visit, and 1 week, 2 months, 6 months and 12 months after the final therapy sessions (about 16 months total).
Measured: 16 months
The Impact on Family Scale
Assesses parental perceptions of the impact of a child's medical condition on the family; higher scores indicate greater financial burden on the family. Assessed at baseline visit, and 1 week, 2 months, 6 months and 12 months after the final therapy sessions (about 16 months total).
Measured: 16 months
Childhood Trauma Questionnaire
History of physical, sexual and/or emotional abuse and physical and emotional neglect. All clinical subscales have a score range of 5-25, higher scores indicate greater abuse/neglect. Completed by participant. Assessed at baseline visit.
Measured: At baseline
The Revised Children's Anxiety and Depression Scale (RCADS)
Measures anxiety and depression symptoms in children; total score ranges from 0-141, higher scores indicate increased symptom severity. Completed by participant and parent. Assessed at baseline visit, and 1 week, 2 months, 6 months and 12 months after the final therapy sessions (about 16 months total).
Measured: 16 months
The Columbia Suicide Severity Rating Scale (C-SSRS)
Measure that addresses the full range of suicidal thoughts and behaviors that suggest a person is at heightened risk of committing suicide; score ranges from 0-25, higher score indicates greater suicidal ideation intensity. Completed by trained research study coordinator.Assessed at baseline visit, and 1 week, 2 months, 6 months and 12 months after the final therapy sessions (about 16 months total).
Measured: 16 months
Healthcare Related Stigma Questionnaire
Measures stigma in patients and their parents related to their interaction with health care; scores ranges from 0-64, higher scores indicate greater stigma. Completed by participant and parent. Assessed at baseline visit.
Measured: At Baseline
COVID-19 Functional Neurological Disorders (FND) Questionnaire
Assesses the effect of COVID-19 diagnosis in FND patients (not on a rating scale). Completed by children. Assessed at baseline visit.
Measured: At Baseline
Flanker Inhibitory Control and Attention Subtest
Subtest of the National Institute of Health Toolbox Cognition Battery. Measures executive function and attention; higher scores indicate better performance. Completed by children. Assessed at 1st therapy session, and 1 week and 2 months after 12th therapy session (about 7 months total).
Measured: 7 months
List Sorting Working Memory Subtest
Subtest of the National Institute of Health Toolbox Cognition Battery. Measures working memory; higher scores indicate better performance. Completed by children. Assessed at 1st therapy session, and 1 week and 2 months after 12th therapy session (about 7 months total).
Measured: 7 months
Pattern Comparison Processing Speed Subtest
Subtest of the National Institute of Health Toolbox Cognition Battery. Measures processing speed; higher scores indicate better performance. Completed by children. Assessed at 1st therapy session, and 1 week and 2 months after 12th therapy session (about 7 months total).
Measured: 7 months
Dimensional Change Card Sort Subtest
Subtest of the National Institute of Health Toolbox Cognition Battery. Measures executive function; higher scores indicate better performance. Completed by children. Assessed at 1st therapy session, and 1 week and 2 months after 12th therapy session (about 7 months total).
Measured: 7 months
Picture Sequence Memory Subtest
Subtest of the National Institute of Health Toolbox Cognition Battery. Measures episodic memory; higher scores indicate better performance. Completed by children. Assessed at 1st therapy session, and 1 week and 2 months after 12th therapy session (about 7 months total).
Measured: 7 months
Sleep Duration
Measures total sleep duration in a 24-hour day. Objectively measured using Respironics Actiwatch Spectrum Pro and subjectively measured using sleep diaries. Worn/completed by children. Assessed for 1 week between baseline visit and 1st therapy session and 2 weeks between 11th therapy session and 1 week after 12th therapy session (about 4 months total).
Measured: 4 months
Sleep Efficiency
Measures quality of sleep. Objectively measured using Respironics Actiwatch Spectrum Pro and subjectively measured using sleep diaries. Worn/completed by children. Assessed for 1 week between baseline visit and 1st therapy session and 2 weeks between 11th therapy session and 1 week after 12th therapy session (about 4 months total).
Measured: 4 months
Sleep Onset Latency
Refers to the time it took the child to fall asleep after lying down in bed. Objectively measured using Respironics Actiwatch Spectrum Pro and subjectively measured using sleep diaries. Worn/completed by children. Assessed for 1 week between baseline visit and 1st therapy session and 2 weeks between 11th therapy session and 1 week after 12th therapy session (about 4 months total).
Measured: 4 months
Sleep - Bed Time
Measures total time in bed in a 24-hour day. Objectively measured using Respironics Actiwatch Spectrum Pro and subjectively measured using sleep diaries. Worn/completed by children. Assessed for 1 week between baseline visit and 1st therapy session and 2 weeks between 11th therapy session and 1 week after 12th therapy session (about 5 months total).
Measured: 5 months
Sleep - Wake Time
Measures total awake time in a 24-hour day. Objectively measured using Respironics Actiwatch Spectrum Pro and subjectively measured using sleep diaries. Worn/completed by children. Assessed for 1 week between baseline visit and 1st therapy session and 2 weeks between 11th therapy session and 1 week after 12th therapy session (about 4 months total).
Measured: 4 months
PNES Episode Frequency
Measures the total number of PNES episodes the child had in a day. Objectively measured using Respironics Actiwatch Spectrum Pro. Worn by children. Assessed for 1 week between baseline visit and 1st therapy session and 2 weeks between 11th therapy session and 1 week after 12th therapy session (about 4 months total).
Measured: 4 months
PNES Episode Duration
Measures the duration of a PNES episode. Objectively measured using Respironics Actiwatch Spectrum Pro. Worn by children. Assessed for 1 week between baseline visit and 1st therapy session and 2 weeks between 11th therapy session and 1 week after 12th therapy session (about 4 months total).
Measured: 4 months
Rosenberg Self-esteem scale
This is a 10-item scale measuring self esteem. Score ranges from 0-30 with low scores indicating low self-esteem. Completed by participant at baseline visit and follow-up visits.
Measured: 16 months
Beaver's Self-Report Family Inventory
This is a 36 item scale which assesses a family member's view of overall family competence. Completed by participant at baseline visit. Completed by parent at baseline and follow-up visits.
Measured: 16 months
FND Locus of Control: Multidimensional Health Locus of Control (MHLC) Scales
Measures an individual's belief in his/her ability to control health outcomes. Form C of MHLC scale will be completed by participant and Form A of MHLC scale will be completed by parent. Assessed at baseline visit and follow-up visits.
Measured: 16 months
Dysfunctional Attitude Scale (DAS-9)
Participant will complete this 9-item self-report measure that aims to determine stable negative attitudes that people with depression hold about themselves, the world, and their future. Assessed at baseline visit and follow-up visits.
Measured: 16 months
Mishel Uncertainty in Illness Questionnaire-Community Form (MUIS-C)
Participant will complete this 23-item scale which measures uncertainty about their diagnosis. Assessed at baseline visit and follow-up visits.
Measured: 16 months
Parenting Style and Dimensions Questionnaire (PSDQ Short Version)
This is a 32-item scale assessing parenting style (self and spouse). Completed by parent at baseline visit and 7-day follow-up visit.
Measured: 5 to 7 months
Revised Helping Alliance Questionnaire- II
Revised Helping Alliance Questionnaire-II is a 19-item scale will assess the therapist, children and parents' perception of the therapeutic alliance at follow-ups. Scores ranges from 19-114 with a higher score indicating better therapeutic alliance. Completed at baseline and follow-up visits.
Measured: 16 months
The Credibility/Expectancy Questionnaire
The Credibility/Expectancy Questionnaire will be used to compare treatment expectancy between conditions. It measures how much the patient believes the therapy they are receiving will help to reduce their FS. This will be completed initially after being randomized, after the first session, fourth session, eighth session, and at the follow-up visits.
Measured: 16 months
Session Summary Sheet (SSS)
Assesses parent and participant's therapeutic relationship, mastery of skill and involvement in therapy session. Completed by therapist at each intervention visit.
Measured: 5 to 7 months
Illness Cognitions Scale
Participant will complete this 17-item scale measuring the degree to which they align with the sick role. Assessed at baseline visit and follow-up visits.
Measured: 16 months
Other FND Symptoms Questionnaire
Assesses if participant has other functional symptoms (independent from their PNES), and evaluates the intensity and frequency of these symptoms. Completed by parent at Baseline and follow-up visits
Measured: 16 months
Clinical Global Impression
Assesses the participant's improvement in FS/FND symptoms due to treatment intervention. Completed by therapist at every treatment session.
Measured: 5 to 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start9 Mar 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Convulsion, Non-EpilepticStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Children with PNES and matched controls will be prospectively enrolled. PNES participants will be randomized to either supportive therapy or Retraining and Control Therapy (ReACT).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Aaron Fobian, University of Alabama at Birmingham
- Investigators
- Aaron Fobian, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06007053
- Sponsor's protocol ID
- IRB-151001004
- Other IDs
- R33MH127155-03
- Acronym
- ReACT
- Status last verified
- Mar 2026
- First submitted
- 11 Aug 2023
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retraining and Control Therapy (ReACT): Sense of Control and Catastrophic Symptom Expectations as Targets of a Cognitive Behavioral Treatment for Pediatric Psychogenic Non-epileptic Seizures (PNES) - R33 Phase
- ClinicalTrials.gov ID
- NCT06007053
- Acronym / sponsor ID
- ReACT / IRB-151001004
- Conditions
- Convulsion, Non-Epileptic
- Keywords
- Supportive therapy, ReACT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 9 Mar 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess sense of control and catastrophic symptom expectations as targets for Retraining and Control Therapy (ReACT- an intervention focused on changing behaviors and thoughts) for treatment of pediatric psychogenic non-epileptic seizures (PNES, episodes resembling epileptic seizures but with no correlated epileptiform activity). 11-18-year-olds diagnosed with PNES will engage in twelve sessions of either ReACT or supportive therapy. Sense of control over actions will be measured by the magic and turbulence task, a well-validated measure of sense of control. Participants will complete the cold pressor test (CPT) in which participants hold their hand in cool water for as long as possible up to 3 minutes. Catastrophic symptom expectations in response to the CPT will be measured by Pain Catastrophizing Scale for Children (PCS-C), pain tolerance (time with hand in water) and cortisol response. Target assessments occur 7 days before treatment, 7 days after 12th treatment session, and 2 months after the 12th treatment session. Long term follow-up assessments will occur 6 months and 12 months after the 12th treatment session. PNES frequency will be measured from 30 days before to 12 months after treatment.
Detailed description
Participants with PNES and their parent come to our laboratory for a baseline visit and 4 follow-up visits. After the baseline visit, participants are randomized to 12 sessions of either Retraining and Control Therapy (ReACT) or supportive therapy. The first therapy session is in-person, and the following 11 sessions are completed via telehealth.
During the baseline visit, participants and their parent complete several questionnaires assessing demographics, mood and suicidality, relationships with friends and family, as well as past and current PNES symptoms. They also complete the childhood trauma questionnaire. The treatment targets (sense of control and catastrophic symptom expectations) are measured by the magic and turbulence computer task and pain tolerance, PCS-C and cortisol response to the CPT, respectively. PNES diaries are completed to assess PNES frequency over the previous 30 days. The baseline lab visit lasts about 2.5 hours. Saliva is collected over 1 time point before and 3 time points after the CPT to measure cortisol response to the CPT. Participants also collect 2 saliva samples 24 hours later to serve as a baseline outside of the laboratory setting. Participants will also be given a Respironics Actiwatch Spectrum Pro to track sleep and PNES episode severity and frequency for the 1 week between the baseline visit and first therapy session.
After the baseline visit, participants are scheduled to return in one week for their first of 12 intervention sessions of either ReACT or supportive therapy. This first session lasts a maximum of two hours, and the following 11 sessions are scheduled weekly and last one hour. The following 11 sessions are conducted as telehealth visits via HIPAA-compliant Zoom. Before beginning the first ReACT session, participants will complete the Flanker Inhibitory Control and Attention, List Sorting Working Memory, Pattern Comparison Processing Speed, Dimensional Change Card Sort, and Picture Sequence Memory subtests. Participants will be mailed another Respironics Actiwatch Spectrum Pro before the 11th therapy session to track sleep and PNES episode severity and frequency for the 2 weeks between the 11th therapy session and the lab visit one week after the 12th treatment session.
Follow-up at 7 days after treatment and 2 months after treatment also is conducted to perform tasks and complete follow-up assessment of the targets (sense of control and catastrophic symptom expectations), PNES frequency, and questionnaires. Each of these sessions last 2 hours. Participants will complete the Flanker Inhibitory Control and Attention, List Sorting Working Memory, Pattern Comparison Processing Speed, Dimensional Change Card Sort, and Picture Sequence Memory subtests at the lab visit at each of these visits. Participants will be mailed and asked to collect 2 saliva samples 1 day before they come in for their follow-up lab visit occuring 7 days after treatment. Participcants will complete 2 Zoom visits at 6 months and 12 months after treatment to assess long-term PNES outcomes and questionnaire data. These appointments will last 1 hour. PNES frequency will be measured from 30 days before treatment to 12 months after treatment through PNES diaries completed by the parent and the participant.
Participants will be offered the treatment to which they were not randomized after the 2-month follow-up when the study is completed.
After treatment, booster therapy sessions will be offered as needed.
Healthy controls will be recruited. Healthy controls and their parent come for a baseline laboratory visit and a follow up visit 13 weeks after the baseline visit. The baseline and follow-up appointments for healthy controls will be identical to the visits for children with PNES.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Children with PNES and matched controls will be prospectively enrolled. PNES participants will be randomized to either supportive therapy or Retraining and Control Therapy (ReACT).
| Arm | Type | Receives |
|---|---|---|
| ReACT Intervention | Experimental | Behavioral: ReACTAt the end of the baseline visit, half of the participants will be randomized to receive Retraining and Control Therapy (ReACT) |
| Supportive Therapy | Active comparator | Behavioral: Supportive TherapyAt the end of the baseline visit, half of the participants will be randomized to receive supportive therapy |
| Healthy Control | No intervention | –Healthy controls are ages 12-18 with no significant comorbid medical or mental health conditions. Healthy controls and their parent come for 1 baseline laboratory visit and a follow up visit 13 weeks after the baseline visit. These visits will be identical to baseline and follow-up visits of children with PNES. |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 11-18 years old.
- Diagnosis of psychogenic non-epileptic seizures by a medical doctor using video-EEG.
- Family member (parent/guardian if a minor) willing to participate and that the subject with PNES chooses.
Key exclusion criteria (8 listed)
- Comorbid Epilepsy
- Less than 4 PNES per month
- Other paroxysmal nonepileptic events (e.g. episodes related to hypoxic-ischemic phenomena, sleep disorders or migraine-associated disorders)
- Participation in other therapy during the study
- Severe intellectual disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReACTAlso: Retraining and Control TherapyReACT is a novel cognitive behavioral treatment and is a PNES intervention that targets sense of control and catastrophic symptom expectations. ReACT consists of 12 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. | Behavioural | ReACT Intervention |
| Supportive TherapyThe supportive therapy treatment consists of 12 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. | Behavioural | Supportive Therapy |
Primary outcome
Magic and turbulence task
Time frame: 7 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, and 1 week and 2 months after the final therapy sessions (about 7 months total).
Pain catastrophizing scale for children- situation specific
Time frame: 7 months
Measures catastrophic symptom expectations; score ranges from 0-52, higher scores indicate greater levels of pain-related anxiety. Assessment done after performing Cold Pressor Test. Assessed at baseline visit, and 1 week and 2 months after the final therapy sessions (about 7 months total).
Pain tolerance (time)
Time frame: 7 months
Measures catastrophic symptom expectations. Measured by the total time the participant can keep their hand in cool water during the Cold Pressor Test. Shorter time indicates less pain tolerance. Assessed at baseline visit, and 1 week and 2 months after the final therapy sessions (about 7 months total).
Salivary Cortisol
Time frame: 7 months
Measures catastrophic symptom expectations. Measured before and after the cold pressor test. Increased cortisol response indicate increased perceived pain severity. Assessed at baseline visit, and 1 week and 2 months after the final therapy sessions (about 7 months total).
Pain Rating Scale
Time frame: 7 months
Measures perceived pain severity after the CPT; score ranges from 0-100. Higher scores indicate greater perceived pain severity. Assessed at baseline visit, and 1 week and 2 months after the final therapy sessions (about 7 months total).
Stroop task
Time frame: 7 months
Measure of cognitive inhibition and selective attention, higher scores means poorer cognitive inhibition and selective attention. Assessed at baseline visit, and 1 week and 2 months after the final therapy sessions (about 7 months total).
39 secondary outcomes
PNES Frequency
Time frame: 16 months
Pain Catastrophizing Scale for Children (PCS-C)- General
Time frame: 7 months
Children's Somatic Symptoms Inventory (CSSI-24)
Time frame: 16 months
Anxiety Sensitivity Index (ASI)
Time frame: 16 months
Shipley
Time frame: At Baseline
Quality of Life in Epilepsy for Adolescents (QOLIE-AD-48)
Time frame: 16 months
Sense of Agency Question
Time frame: 16 months
LEVEL 2-Somatic Symptom report adapted from the Participant Health Questionnaire
Time frame: 16 months
Functional Disability Inventory (FDI)
Time frame: 16 months
The Impact on Family Scale
Time frame: 16 months
Childhood Trauma Questionnaire
Time frame: At baseline
The Revised Children's Anxiety and Depression Scale (RCADS)
Time frame: 16 months
The Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: 16 months
Healthcare Related Stigma Questionnaire
Time frame: At Baseline
COVID-19 Functional Neurological Disorders (FND) Questionnaire
Time frame: At Baseline
Flanker Inhibitory Control and Attention Subtest
Time frame: 7 months
List Sorting Working Memory Subtest
Time frame: 7 months
Pattern Comparison Processing Speed Subtest
Time frame: 7 months
Dimensional Change Card Sort Subtest
Time frame: 7 months
Picture Sequence Memory Subtest
Time frame: 7 months
Sleep Duration
Time frame: 4 months
Sleep Efficiency
Time frame: 4 months
Sleep Onset Latency
Time frame: 4 months
Sleep - Bed Time
Time frame: 5 months
Sleep - Wake Time
Time frame: 4 months
PNES Episode Frequency
Time frame: 4 months
PNES Episode Duration
Time frame: 4 months
Rosenberg Self-esteem scale
Time frame: 16 months
Beaver's Self-Report Family Inventory
Time frame: 16 months
FND Locus of Control: Multidimensional Health Locus of Control (MHLC) Scales
Time frame: 16 months
Dysfunctional Attitude Scale (DAS-9)
Time frame: 16 months
Mishel Uncertainty in Illness Questionnaire-Community Form (MUIS-C)
Time frame: 16 months
Parenting Style and Dimensions Questionnaire (PSDQ Short Version)
Time frame: 5 to 7 months
Revised Helping Alliance Questionnaire- II
Time frame: 16 months
The Credibility/Expectancy Questionnaire
Time frame: 16 months
Session Summary Sheet (SSS)
Time frame: 5 to 7 months
Illness Cognitions Scale
Time frame: 16 months
Other FND Symptoms Questionnaire
Time frame: 16 months
Clinical Global Impression
Time frame: 5 to 7 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aaron Fobian, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ReACT and Supportive Therapy in people with Convulsion, Non-Epileptic, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aaron Fobian, PhD (205-934-2241, afobian@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magic and turbulence task (time frame: 7 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.