Biomolecular Characteristics of Reminder-Focused Positive-Psychiatry

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age11-15
SponsorUniversity of California, Los Angeles

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Boy/Girl with documented PTSD,

aged 11- 15 years old,

able to read/write in English

Disqualifiers

presence of intellectual disabilities,

presence of psychotic or self-injurious behavior,

presence of seizure disorder,

presence of language disorder,

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • 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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: RFPP group interventionActive comparator 1 intervention
Group B: attentional control condition (group process)Sham comparator 1 intervention

Trial outcomes

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

Time frame
24 months

Secondary outcomes

1

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

Time frame
24 months
2

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

Time frame
24 months

Other outcomes

Sponsors and contacts

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