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NCT06007053 · ClinicalTrials.gov registry record · NA
Retraining and Control Therapy (ReACT) R33 Phase
A NA study of Convulsion, Non-Epileptic, sponsored by University of Alabama at Birmingham.
- Recruiting
- Registry status
- NA
- Development phase
- 160
- Enrollment target
- 1
- Study location
NCT06007053: Recruiting NA study of Convulsion, Non-Epileptic, sponsored by University of Alabama at Birmingham.
NCT06007053 is a NA study of Convulsion, Non-Epileptic that is actively recruiting participants, run by University of Alabama at Birmingham. The registered enrollment target is 160 participants, below the 332-participant average among 4 other Convulsion, Non-Epileptic trials with a reported enrollment target (52% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06007053, a NA study of Convulsion, Non-Epileptic, is actively recruiting participants, sponsored by University of Alabama at Birmingham.
- RECRUITING
- Registry status
- NA
- Development phase
- 160 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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).
Conditions Studied
Interventions
- BEHAVIORAL ReACT
- BEHAVIORAL Supportive Therapy
Study Locations (1)
Alabama
- University of Alabama at Birmingham - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2024-03-09 |
| Est. Completion | 2026-12-31 |
| Phase | NA |
What NCT06007053 shows while recruiting
NCT06007053 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, below the 332-participant average among 4 other Convulsion, Non-Epileptic trials with a reported enrollment target (52% lower).
The record links to 1 condition, with Convulsion, Non-Epileptic appearing as the primary indexed condition, and to 2 interventions - of which ReACT is the first listed.
NCT06007053 reports a single indexed study location in Alabama.
Frequently Asked Questions
What is clinical trial NCT06007053 about?
NCT06007053 is a clinical study titled "Retraining and Control Therapy (ReACT) 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 epi...
What is the current status of trial NCT06007053?
This trial is currently recruiting. It is a NA study. The enrollment target is 160 participants. The study started on 2024-03-09. Estimated completion is 2026-12-31.
What conditions does trial NCT06007053 study?
This clinical trial studies the following conditions: Convulsion, Non-Epileptic.
What interventions are being tested in trial NCT06007053?
The interventions under investigation include: ReACT (BEHAVIORAL), Supportive Therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT06007053?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06007053 being conducted?
This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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