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Biomolecular Characteristics of Reminder-Focused Positive-Psychiatry (RFPP)

Primary Purpose

Posttraumatic Stress Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reminder Focused Positive Psychiatry
attentional control condition (group process)
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder

Eligibility Criteria

11 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UCLARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

RFPP group intervention

attentional control condition (group process)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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

Full Information

First Posted
August 20, 2020
Last Updated
May 16, 2022
Sponsor
University of California, Los Angeles
Collaborators
UCLA Cousins Center for Psychoneuroimmunology
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1. Study Identification

Unique Protocol Identification Number
NCT04529031
Brief Title
Biomolecular Characteristics of Reminder-Focused Positive-Psychiatry
Acronym
RFPP
Official Title
Clinical and Biomolecular Characteristics of Reminder-Focused Positive-Psychiatry in Adolescent With Posttraumatic Stress Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
December 28, 2023 (Anticipated)
Study Completion Date
December 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
UCLA Cousins Center for Psychoneuroimmunology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RFPP group intervention
Arm Type
Active Comparator
Arm Description
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.
Arm Title
attentional control condition (group process)
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Reminder Focused Positive Psychiatry
Other Intervention Name(s)
Subjects will receive progressive muscle relaxation and other relaxation techniques as well as education about PTSD and supportive psychotherapy
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
attentional control condition (group process)
Other Intervention Name(s)
focused relaxation intervention
Intervention Description
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
Primary Outcome Measure Information:
Title
To examine the impact of RFPP intervention on core PTSD symptoms
Description
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 Outcome Measure Information:
Title
To assess the impact of RFPP on well-being of adolescents with PTSD and their parents
Description
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
Title
To examine the impact of RFPP on biologic biomarkers, compared to control group
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Naser Ahmadi, MD PhD
Phone
424 298 8846
Email
ahmadi@ucla.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Naser Ahmadi, MD PhD
Phone
4242988846
Email
nahmadi@mednet.ucla.edu
Facility Information:
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naser Ahmadi, MD
Phone
424-442-0585
Email
nahmadi@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Naser Ahmadi, MD PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Biomolecular Characteristics of Reminder-Focused Positive-Psychiatry

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