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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Pain tolerance (time)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Researchers who conduct baseline and follow-up visits will be blinded to the condition to which the patient has been assigned. The statistician and data manger will be blinded to treatment condition when analyzing data. The PI and therapists will be blinded to participant's baseline target scores.
入排标准
- 年龄范围
- 11 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
ReACT Intervention
At the end of the baseline visit, half of the participants will be randomized to receive Retraining and Control Therapy (ReACT)
干预措施: ReACT (Behavioral)
Supportive Therapy
At the end of the baseline visit, half of the participants will be randomized to receive supportive therapy
干预措施: Supportive Therapy (Behavioral)
Healthy Control
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.
结局指标
主要结局
Pain tolerance (time)
时间窗: 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).
Pain Rating Scale
时间窗: 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
时间窗: 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).
Magic and turbulence task
时间窗: 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
时间窗: 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).
Salivary Cortisol
时间窗: 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).
次要结局
- PNES Frequency(16 months)
- Pain Catastrophizing Scale for Children (PCS-C)- General(7 months)
- Shipley(At Baseline)
- Children's Somatic Symptoms Inventory (CSSI-24)(16 months)
- Anxiety Sensitivity Index (ASI)(16 months)
- Quality of Life in Epilepsy for Adolescents (QOLIE-AD-48)(16 months)
- Sense of Agency Question(16 months)
- LEVEL 2-Somatic Symptom report adapted from the Participant Health Questionnaire(16 months)
- Functional Disability Inventory (FDI)(16 months)
- The Impact on Family Scale(16 months)
- Childhood Trauma Questionnaire(At baseline)
- The Revised Children's Anxiety and Depression Scale (RCADS)(16 months)
- The Columbia Suicide Severity Rating Scale (C-SSRS)(16 months)
- Healthcare Related Stigma Questionnaire(At Baseline)
- COVID-19 Functional Neurological Disorders (FND) Questionnaire(At Baseline)
- Flanker Inhibitory Control and Attention Subtest(7 months)
- List Sorting Working Memory Subtest(7 months)
- Pattern Comparison Processing Speed Subtest(7 months)
- Dimensional Change Card Sort Subtest(7 months)
- Picture Sequence Memory Subtest(7 months)
- Sleep Duration(4 months)
- Sleep Efficiency(4 months)
- Sleep Onset Latency(4 months)
- Sleep - Bed Time(5 months)
- Sleep - Wake Time(4 months)
- PNES Episode Frequency(4 months)
- PNES Episode Duration(4 months)
- Rosenberg Self-esteem scale(16 months)
- Beaver's Self-Report Family Inventory(16 months)
- FND Locus of Control: Multidimensional Health Locus of Control (MHLC) Scales(16 months)
- Dysfunctional Attitude Scale (DAS-9)(16 months)
- Mishel Uncertainty in Illness Questionnaire-Community Form (MUIS-C)(16 months)
- Parenting Style and Dimensions Questionnaire (PSDQ Short Version)(5 to 7 months)
- Revised Helping Alliance Questionnaire- II(16 months)
- The Credibility/Expectancy Questionnaire(16 months)
- Session Summary Sheet (SSS)(5 to 7 months)
- Illness Cognitions Scale(16 months)
- Other FND Symptoms Questionnaire(16 months)
- Clinical Global Impression(5 to 7 months)
研究者
Aaron Fobian
Associate Professor
University of Alabama at Birmingham