Clinical trial NCT06007053: Retraining and Control Therapy (ReACT) R33 Phase
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Convulsion, Non-Epileptic
Keywords: Supportive therapy
ReACT
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-08-23
Enrollment: 160
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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)

Exclusion for CPT:

* 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

Primary outcomes:
measure: Magic and turbulence task
timeFrame: 7 months
measure: Pain catastrophizing scale for children- situation specific
timeFrame: 7 months
measure: Pain tolerance (time)
timeFrame: 7 months
measure: Salivary Cortisol
timeFrame: 7 months
measure: Pain Rating Scale
timeFrame: 7 months
measure: Stroop task
timeFrame: 7 months
Secondary outcomes:
measure: PNES Frequency
timeFrame: 16 months
measure: Pain Catastrophizing Scale for Children (PCS-C)- General
timeFrame: 7 months
measure: Children's Somatic Symptoms Inventory (CSSI-24)
timeFrame: 16 months
measure: Anxiety Sensitivity Index (ASI)
timeFrame: 16 months
measure: Shipley
timeFrame: At Baseline
measure: Quality of Life in Epilepsy for Adolescents (QOLIE-AD-48)
timeFrame: 16 months
measure: Sense of Agency Question
timeFrame: 16 months
measure: LEVEL 2-Somatic Symptom report adapted from the Participant Health Questionnaire
timeFrame: 16 months
measure: Functional Disability Inventory (FDI)
timeFrame: 16 months
measure: The Impact on Family Scale
timeFrame: 16 months
measure: Childhood Trauma Questionnaire
timeFrame: At baseline
measure: The Revised Children's Anxiety and Depression Scale (RCADS)
timeFrame: 16 months
measure: The Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: 16 months
measure: Healthcare Related Stigma Questionnaire
timeFrame: At Baseline
measure: COVID-19 Functional Neurological Disorders (FND) Questionnaire
timeFrame: At Baseline
measure: Flanker Inhibitory Control and Attention Subtest
timeFrame: 7 months
measure: List Sorting Working Memory Subtest
timeFrame: 7 months
measure: Pattern Comparison Processing Speed Subtest
timeFrame: 7 months
measure: Dimensional Change Card Sort Subtest
timeFrame: 7 months
measure: Picture Sequence Memory Subtest
timeFrame: 7 months
measure: Sleep Duration
timeFrame: 4 months
measure: Sleep Efficiency
timeFrame: 4 months
measure: Sleep Onset Latency
timeFrame: 4 months
measure: Sleep - Bed Time
timeFrame: 5 months
measure: Sleep - Wake Time
timeFrame: 4 months
measure: PNES Episode Frequency
timeFrame: 4 months
measure: PNES Episode Duration
timeFrame: 4 months
measure: Rosenberg Self-esteem scale
timeFrame: 16 months
measure: Beaver's Self-Report Family Inventory
timeFrame: 16 months
measure: FND Locus of Control: Multidimensional Health Locus of Control (MHLC) Scales
timeFrame: 16 months
measure: Dysfunctional Attitude Scale (DAS-9)
timeFrame: 16 months
measure: Mishel Uncertainty in Illness Questionnaire-Community Form (MUIS-C)
timeFrame: 16 months
measure: Parenting Style and Dimensions Questionnaire (PSDQ Short Version)
timeFrame: 5 to 7 months
measure: Revised Helping Alliance Questionnaire- II
timeFrame: 16 months
measure: The Credibility/Expectancy Questionnaire
timeFrame: 16 months
measure: Session Summary Sheet (SSS)
timeFrame: 5 to 7 months
measure: Illness Cognitions Scale
timeFrame: 16 months
measure: Other FND Symptoms Questionnaire
timeFrame: 16 months
measure: Clinical Global Impression
timeFrame: 5 to 7 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Aaron Fobian, PhD
role: PRINCIPAL_INVESTIGATOR
References: