Biomolecular Characteristics of Reminder-Focused Positive-Psychiatry

Posttraumatic Stress Disorder Clinical Trial

— RFPP  

Official title:

Clinical and Biomolecular Characteristics of Reminder-Focused Positive-Psychiatry in Adolescent With Posttraumatic Stress Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04529031
• Other study ID #: IRB#20-000444
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: December 28, 2023

Study information

• Verified date: May 2022
• Source: University of California, Los Angeles
• Contact: Naser Ahmadi, MD PhD
• Phone: 424 298 8846
• Email: ahmadi[@]ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 expression biomarkers in response to RFPP, and c) changes in parents' wellbeing and biopsychosocial trait as well as child-parent interactions.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 28, 2023
• Est. primary completion date: December 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 15 Years

Eligibility

Inclusion Criteria:

• Boy/Girl with documented PTSD,

• aged 11- 15 years old,

• able to read/write in English

Exclusion Criteria:

• presence of intellectual disabilities,

• presence of psychotic or self-injurious behavior,

• presence of seizure disorder,

• presence of language disorder,

• presence of eye disorders,

• presence of other neurodevelopmental disorders,

• presence of diagnosis of substance use disorder.

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Reminder Focused Positive Psychiatry
The focus of RFPP is on enhancing contextual discrimination and emotional regulation, and promoting the use of adaptive coping strategies in response to trauma reminders, including recognizing reminders, shifting attention from intrusive memories during exposure to reminders to a focus on positive feelings, thoughts, goals, and choices
• attentional control condition (group process)
This group process will undergo telehealth relaxation therapy twice a week for 6-week. Subjects will receive progressive muscle relaxation and other relaxation techniques as well as education about PTSD and supportive psychotherapy

Locations

Country	Name	City	State
United States	UCLA	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	UCLA Cousins Center for Psychoneuroimmunology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To examine the impact of RFPP intervention on core PTSD symptoms	There will be a change in core PTSD symptoms (% ranged from 0-100) after 6-week RFPP intervention, compared to control group	24 months
Secondary	To assess the impact of RFPP on well-being of adolescents with PTSD and their parents	There will be a change in well-being (% ranged from 0-100), posttraumatic growth (% ranged from 0-100), and parent-child interactions (% ranged from 0-100) in adolescents with PTSD who received RFPP, compared to control group	24 months
Secondary	To examine the impact of RFPP on biologic biomarkers, compared to control group	There will be a change in vascular function ((% ranged from 0-100), stress involved gene expression (% ranged from 0-100), C reactive protein (CRP)(% ranged from 0-100) and homocysteine (% ranged from 0-100) in response to RFPP in adolescents with PTSD	24 months