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NCT04529031 · ClinicalTrials.gov registry record · NA
Biomolecular Characteristics of Reminder-Focused Positive-Psychiatry
A NA study of Posttraumatic Stress Disorder, sponsored by University of California, Los Angeles.
- Recruiting
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT04529031 is a NA study of Posttraumatic Stress Disorder that is actively recruiting participants, run by University of California, Los Angeles. The registered enrollment target is 60 participants, below the 111-participant average among 117 other Posttraumatic Stress Disorder trials with a reported enrollment target (46% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04529031, a NA study of Posttraumatic Stress Disorder, is actively recruiting participants, sponsored by University of California, Los Angeles.
- RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
Objective: Posttraumatic stress disorder (PTSD) is a prevalent neuropsychiatric disorder in children and is associated with increased neurovascular inflammation, suicidality, adulthood mental health disorder, and major adverse events. Reminder focused positive psychiatry (RFPP) has been shown as well tolerated feasible trauma focused intervention that is associated with improved core PTSD symptoms, decreased severity of reactivity to PTSD trauma reminders, and increased vascular function. This study evaluates the clinical and biomolecular characteristics of RFPP in adolescents with PTSD. Research Design/Overall Impact: After obtaining parents' informed consent and adolescent's assent, 60 adolescents aged 11-15 years old with PTSD, and free of known medical and other major psychiatric disorders will be recruited from the pool of eligible adolescents at Olive View UCLA Pediatrics Clinics (\>3000 adolescents with PTSD). Eligible adolescents will be randomized to 1) RFPP group intervention, or 2) an attentional control condition (group process). Thirty subjects in each group will receive twice weekly telehealth intervention of either RFPP or group process, for 6 weeks, and undergo 4 blinded neuropsychiatric assessments at baseline, 3, 6, and 24 weeks. Parents will receive weekly interventions of either positive psychoeducation or group process, for 6 weeks and undergo baseline, 3, 6- and 24-weeks neuropsychiatric assessment. Vascular function, inflammatory biomarkers including CRP, homocysteine, and stress involved gene expression biomarkers (i.e. changes in gene expression of FKBP5, DDX6, B2M, LAIR1, RTN4, NUB1, and a multi-gene Conserved Transcriptional Response to Adversity score (CTRA) will be measured at baseline and 6-week. The primary and secondary endpoints are a) changes in PTSD core and reactivity to trauma reminder severity score in response to RFPP intervention, b) changes in wellbeing, biopsychosocial trait, vascular function, neuroinflammation and gene ex
Conditions Studied
Interventions
- BEHAVIORAL Reminder Focused Positive Psychiatry
- BEHAVIORAL attentional control condition (group process)
Study Locations (1)
California
- UCLA - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2024-09-01 |
| Est. Completion | 2026-12-28 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04529031
The ClinicalTrials.gov registry entry for NCT04529031 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 111-participant average among 117 other Posttraumatic Stress Disorder trials with a reported enrollment target (46% lower). The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Posttraumatic Stress Disorder appearing as the primary indexed condition, and to 2 interventions - of which Reminder Focused Positive Psychiatry is the first listed.
NCT04529031 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT04529031 about?
NCT04529031 is a clinical study titled "Biomolecular Characteristics of Reminder-Focused Positive-Psychiatry". Objective: Posttraumatic stress disorder (PTSD) is a prevalent neuropsychiatric disorder in children and is associated with increased neurovascular inflammation, suicidality, adulthood mental health disorder, and major adverse events. Reminder focused positive psychiatry (RFPP) has been shown as wel...
What is the current status of trial NCT04529031?
This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2024-09-01. Estimated completion is 2026-12-28.
What conditions does trial NCT04529031 study?
This clinical trial studies the following conditions: Posttraumatic Stress Disorder.
What interventions are being tested in trial NCT04529031?
The interventions under investigation include: Reminder Focused Positive Psychiatry (BEHAVIORAL), attentional control condition (group process) (BEHAVIORAL).
Who is sponsoring clinical trial NCT04529031?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04529031 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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