Retraining and Control Therapy (ReACT): Sense of Control and Symptom Expectations as Targets of a Treatment for PNES

Convulsion, Non-Epileptic Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05096273
• Other study ID #: F151001004-2
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 28, 2021
• Est. completion date: July 31, 2026

Study information

• Verified date: May 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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, 7 days after 12th treatment session, 6 months and 12 months after the 12th treatment session. PNES frequency will be measured from 30 days before to 12 months after treatment.

Description:

PNES participants and their parent come to our laboratory for a baseline visit, 4 follow-up visits and 12 therapy sessions. Half of the participants will be randomized to receive 2 booster therapy sessions. 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 PENS 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 perform tasks and complete follow-up assessment of the targets (sense of control and catastrophic symptom expectations), 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 and 6- and 12-month long-term follow-up visits. Each of these sessions will last 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 68
• Est. completion date: July 31, 2026
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 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:

• 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

Related Conditions & MeSH terms

• Convulsion, Non-Epileptic
• Seizures

Intervention

Behavioral:
• ReACT
ReACT is a novel cognitive behavioral treatment and is a PNES intervention that targets sense of control and catastrophic symptom expectations

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	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, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).	16 months
Primary	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, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).	16 months
Primary	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, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).	16 months
Primary	Salivary cortisol response to Cold Pressor Test	Measures catastrophic symptom expectations. Measured before and after the cold pressor test. Increased cortisol response indicate increased perceived pain severity. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).	16 months
Primary	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, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).	16 months
Primary	Stroop task	Measure of cognitive inhibition and selective attention, higher scores means poorer cognitive inhibition and selective attention. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).	16 months
Secondary	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).; Frequency and severity also measured by Respironics Actiwatch Spectrum Pro. 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).	16 months
Secondary	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, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).	16 months
Secondary	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, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).	16 months
Secondary	Anxiety Sensitivity Index (ASI)	Assesses catastrophic symptom expectations; higher scores indicate greater anxiety. Completed by participant and parent. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).	16 months
Secondary	Shipley	Assesses verbal IQ; higher scores indicate greater verbal IQ. Completed by participant at the baseline visit.	At baseline
Secondary	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, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).	16 months
Secondary	Sense of Agency Scale	Single question which asks "How much control do you believe you have over your PNES?". Completed by participant. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).	16 months
Secondary	LEVEL 2-Somatic Symptom report adapted from the Participant Health Questionnaire Physical Symptoms	Measures symptom severity in children; higher scores indicate greater symptom severity. Completed by participant and parent. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).	16 months
Secondary	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, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).	16 months
Secondary	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, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).	16 months
Secondary	Childhood Trauma Questionnaire	History of physical, sexual and/or emotional abuse and physical and emotional neglect, higher scores indicate greater abuse/neglect. Completed by participant at baseline visit.	At Baseline
Secondary	The Revised Children's Anxiety and Depression Scale (RCADS)	Measures anxiety and depression symptoms in children; higher scores indicate increased symptom severity. Completed by participant and parent. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).	16 months
Secondary	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. Completed by trained research study coordinator. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).	16 months
Secondary	Healthcare Related Stigma Questionnaire	Measures stigma in patients and their parents related to their interaction with health care providers; higher scores indicate greater stigma. Completed by participant and parent. Assessed at baseline visit.	At Baseline
Secondary	COVID-19 Functional Neurological Disorders (FND) Questionnaire	Assesses the effect of COVID-19 diagnosis in FND patients. Completed by Children. Assessed at baseline visit	At Baseline
Secondary	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 after 12th therapy session (about 4 months total).	4 months
Secondary	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 after 12th therapy session (about 4 months total).	4 months
Secondary	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 after 12th therapy session (about 4 months total).	4 months
Secondary	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 after 12th therapy session (about 4 months total).	4 months
Secondary	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 after 12th therapy session (about 4 months total).	4 months
Secondary	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).	4 months
Secondary	PNES Episode Severity	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).	4 months