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NCT05096273 · ClinicalTrials.gov registry record · NA
Retraining and Control Therapy (ReACT): Sense of Control and Symptom Expectations as Targets of a Treatment for PNES
A NA study of Convulsion, Non-Epileptic, sponsored by University of Alabama at Birmingham.
- Recruiting
- Registry status
- NA
- Development phase
- 68
- Enrollment target
- 1
- Study location
NCT05096273: Recruiting NA study of Convulsion, Non-Epileptic, sponsored by University of Alabama at Birmingham.
NCT05096273 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 68 participants, below the 355-participant average among 4 other Convulsion, Non-Epileptic trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05096273, a NA study of Convulsion, Non-Epileptic, is actively recruiting participants, sponsored by University of Alabama at Birmingham.
- RECRUITING
- Registry status
- NA
- Development phase
- 68 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 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.
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, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).
Conditions Studied
Interventions
- BEHAVIORAL ReACT
Study Locations (1)
Alabama
- Sparks Center Office of Psychiatric Research - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2021-10-28 |
| Est. Completion | 2026-12-31 |
| Phase | NA |
What NCT05096273 shows while recruiting
NCT05096273 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 355-participant average among 4 other Convulsion, Non-Epileptic trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Convulsion, Non-Epileptic appearing as the primary indexed condition, and to 1 intervention - of which ReACT is the first listed.
NCT05096273 reports a single indexed study location in Alabama.
Frequently Asked Questions
What is clinical trial NCT05096273 about?
NCT05096273 is a clinical study titled "Retraining and Control Therapy (ReACT): Sense of Control and Symptom Expectations as Targets of a Treatment for PNES". 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 NCT05096273?
This trial is currently recruiting. It is a NA study. The enrollment target is 68 participants. The study started on 2021-10-28. Estimated completion is 2026-12-31.
What conditions does trial NCT05096273 study?
This clinical trial studies the following conditions: Convulsion, Non-Epileptic.
What interventions are being tested in trial NCT05096273?
The interventions under investigation include: ReACT (BEHAVIORAL).
Who is sponsoring clinical trial NCT05096273?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05096273 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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