Clinical trial NCT05096273: Retraining and Control Therapy (ReACT): Sense of Control and Symptom Expectations As Targets of a Treatment for PNES
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Convulsion, Non-Epileptic
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2021-10-27
Enrollment: 68
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.
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 medical explanation). 11-18-year-olds diagnosed with PNES will engage in twelve sessions of ReACT. 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 will occur 7 days before treatment, 7 days after 8th treatment session and 7 days after 12th treatment session. Participants will also complete long term follow-up visits via HIPAA-compliant Zoom at 6 months and 12 months after the 12th treatment session where participants will complete questionnaires. PNES frequency will be measured from 30 days before to 12 months after treatment.

Detailed description: PNES participants and their parent come to our laboratory for a baseline visit, 2 follow-up visits and 12 therapy sessions. Participants will complete 2 long-term follow-up visits at 6 months and 12 months after the 12th treatment session via HIPAA-compliant Zoom. Half of the participants will be randomized to receive 2 booster therapy sessions after treatment. Participants must provide EEG results indicating a diagnosis of psychogenic non-epileptic seizures.

During the initial visit, participants and their parent will complete several questionnaires assessing demographics, mood and suicidality, relationships with friends and family, as well as past and current PNES symptoms. They will also complete the childhood trauma questionnaire. The treatment targets (sense of control and catastrophic symptom expectations), will be measured by the magic and turbulence computer task and pain tolerance, PCS-C and cortisol response to the CPT, respectively. After completing the CPT, participants will be randomized to receive a pain relief lotion or a pain sensitivity lotion. Participants will then repeat the CPT with the lotion applied to their hand. PNES diaries will be completed to assess PNES frequency over the previous 30 days. The baseline lab visit will last about 3 hours. Saliva will be collected over 3 time points before and after each CPT to measure cortisol response to the CPT. Participants will 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 ReACT session.

All participants will then be scheduled to return in one week for their first of 12 sessions of ReACT. 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. This first session will last a maximum of two hours, and the following 11 sessions will be scheduled weekly and will each last one hour. The following 11 sessions are currently conducted via telehealth due to COVID-19. Participants will be mailed another Respironics Actiwatch Spectrum Pro before the 11th therapy session to track sleep and PENS episode severity and frequency for the 2 weeks between the 11th therapy session and the lab visit one week after the 12th treatment session.

To assess treatment dose, participants will return for post lab visits one week after the 8th treatment session and 12th treatment sessions to perform tasks and fill out questionnaires completed at baseline. Long-term follow-up at 6 months and 12 months after treatment will also be conducted to assess FS frequency and questionnaires. 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 after the 12th treatment session. Each of these sessions will last about 1 to 2 hours. 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.

After treatment, half of the participants will be randomized to receive 2 booster therapy sessions at 3 months and 9 months after the end of treatment. Each of these sessions will last one hour.

Healthy controls are matched to participants with PNES based on age (+ or - 1 year), gender, race and family income. 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:

* 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:

* 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
* 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 response to Cold Pressor Test
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: 16 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 Scale
timeFrame: 16 months
measure: LEVEL 2-Somatic Symptom report adapted from the Participant Health Questionnaire Physical Symptoms
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: 4 months
measure: List Sorting Working Memory Subtest
timeFrame: 4 months
measure: Pattern Comparison Processing Speed Subtest
timeFrame: 4 months
measure: Dimensional Change Card Sort Subtest
timeFrame: 4 months
measure: Picture Sequence Memory Subtest
timeFrame: 4 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: 4 months
measure: Sleep - Wake Time
timeFrame: 4 months
measure: PNES Episode Frequency
timeFrame: 4 months
measure: PNES Episode Duration
timeFrame: 4 months
measure: Child Self-Report Tic Questionnaire
timeFrame: 16 months
measure: Parent Tic Questionnaire
timeFrame: 16 months
measure: Yale Global Tic Severity Scale
timeFrame: 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Sparks Center Office of Psychiatric Research
state: Alabama
Study officials:
References: