Biomolecular Characteristics of Reminder-Focused Positive-Psychiatry

NCT04529031 | Recruiting DMC

• 1 other identifier: IRB#20-000444
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Posttraumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• To assess the impact of RFPP on well-being of adolescents with PTSD and their parents

  24 months

• To examine the impact of RFPP on biologic biomarkers, compared to control group

  24 months

Study Arms (2)

RFPP group intervention

ACTIVE COMPARATOR

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.

Behavioral: Reminder Focused Positive Psychiatry

attentional control condition (group process)

SHAM COMPARATOR

Subjects will receive progressive muscle relaxation and other relaxation techniques as well as education about PTSD and supportive psychotherapy. Parents will receive 4 sessions of relaxation techniques.

Behavioral: attentional control condition (group process)

Interventions

Reminder Focused Positive Psychiatry BEHAVIORAL

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

Also known as: Subjects will receive progressive muscle relaxation and other relaxation techniques as well as education about PTSD and supportive psychotherapy

RFPP group intervention

attentional control condition (group process) BEHAVIORAL

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

Also known as: focused relaxation intervention

attentional control condition (group process)

Eligibility Criteria

• Age: 11 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Boy/Girl with documented PTSD,
• aged 11- 15 years old,
• able to read/write in English

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA

Los Angeles, California, 90024, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Central Study Contacts

Naser Ahmadi, MD PhD

CONTACT

424 298 8846; ahmadi@ucla.edu

Naser Ahmadi, MD PhD

CONTACT

4242988846; nahmadi@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Study Record Dates

• First Submitted: August 20, 2020
• First Posted: August 27, 2020
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 28, 2027
• Study Completion (Estimated): December 28, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)