There are three research questions: (1) whether the Primary Care Intervention for PTSD (PCIP) improves health outcomes; (2) whether and how the PCIP can be sustainably delivered via telehealth; and (3) how PCIP compares to treatment as usual (TAU) participants. The mixed methods randomized feasibility trial of the protocol will be measured by the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, Maintenance) (n=44 patients and their care givers). We will collect data on patient, caregiver, and clinic staff participation, retention, and satisfaction (Reach and Adoption), change in hypothesized treatment mechanisms and symptoms (Effectiveness), and facilitators and barriers to intervention delivery and fidelity (Implementation). We will, 1. Assess the reach and adoption of the protocol by analyzing quantitative data on patient and clinic staff participation, retention, and satisfaction; 2. Explore the effectiveness of the protocol through medical record review, quantitative assessments at baseline and post-treatment, and semi-structured qualitative interviews at baseline and post-treatment to: 3. Evaluate the implementation of the screening and intervention protocol with post-intervention semi-structured qualitative interviews to assess facilitators and barriers to intervention delivery, quantitative fidelity scales, observation of screening, and review of intervention audio recordings to assess fidelity to the protocol and intervention process.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
This program is adapted from the "B.R.E.A.T.H.E. - Brief Relaxation, Education and Trauma Healing: A Brief Intervention for Persons with PTSD and Co- Occurring Serious Mental Health Conditions. Treatment Program Manual and Patient Handouts (Version 3) by Kim T. Mueser, Rachael Fite, Stanley D. Rosenberg, and Jennifer D. Gottlieb.
Receive standard care treatment and are provided information on free or low cost mental health care referrals in the Los Angeles Area.
University of California Los Angeles
Los Angeles, California, United States
Change in PTSD Knowledge
Changes in levels of PTSD Knowledge measured by the PTSD Knowledge Test (0-14, higher scores indicating more PTSD knowledge)
Time frame: Day 0 baseline, 10 months
Change in Trauma-Related Cognitions
Changes in post-traumatic cognitions measured by the Post-Traumatic Cognitions Inventory (1-7, Higher scores indicating more post traumatic cognitions)
Time frame: Day 0 baseline, 10 months
Change in Self-Reported Arousal
Changes in PTSD related arousal levels measured by the Composite Autonomic Symptom Score (COMPASS-31; 0-100 total, Higher scores indicating higher arousal)
Time frame: Day 0 baseline, 10 months
Change in Stress Management Skill Use
Changes in PTSD related arousal levels measured Measure of Adolescent Coping Strategies (MACS; Total 0-102, higher scores indicate higher use of specified coping), and use of the breathing retraining techniques as measured by self-reports during in-session review.
Time frame: Day 0 baseline, 10 months
Intervention Implementation and Acceptability
Qualitative interviews will include questions regarding acceptability of treatment including treatment via telehealth. Additionally, data will be collected regarding participant completion of therapy, no show rates, barriers to treatment, and attendance. Additionally, study therapists will complete qualitative and quantitative measures regarding intervention delivery feasibility and study protocols.
Time frame: Day 0 baseline, 10 months
Change in PTSD Symptoms
Changes in PTSD related symptoms measured by the UCLA Child/Adolescent PTSD Reaction Index for DSM-5 Brief Screen (total 0-44; Higher scores indicate higher likelihood of PTSD and symptom-related distress and impairment)
Time frame: Day 0 baseline, 10 months
Change in Trauma Symptoms
Changes in trauma related symptoms measured by The Child PTSD Symptom Scale (CPSS-5-SR) Self Report (total 0-80, Higher scores indicated greater symptom severity).
Time frame: Day 0 baseline, 10 months
Change in Adverse Childhood Experiences
Changes in Adverse Childhood Experiences measured by the Pediatric ACEs and Related Life Events Screener (PEARLS; 0-19, higher scores indicate higher risk of traumatic stress.
Time frame: Day 0 baseline, 10 months
Change in Depression Symptoms
Changes in depression symptoms measured by the Center for Epidemiologic Studies Depression Scale (CES-DC) Self Report (total 0-60, Higher scores indicate higher symptom severity).
Time frame: Day 0 baseline, 10 months
Change in Depression Symptoms
Changes in depression symptoms measured by the Patient Health Questionnaire (PHQ-9;0-27; Higher scores indicate higher symptoms and likelihood of depression)
Time frame: Day 0 baseline, 10 months
Change in Anxiety Symptoms
Changes in anxiety symptoms measured by the Revised Children's Anxiety and Depression Scale (RCADS) Self Report (total 0-141, Higher scores indicating higher symptom severity).
Time frame: Day 0 baseline, 10 months
Change in Functional Impairment
Changes in functional impairment measured by The Columbia Impairment Scale (C.I.S.; 0-52, Higher scores indicate greater impairment).
Time frame: Day 0 baseline, 10 months
Change in pro-inflammatory cytokine biomarkers
Changes in pro-inflammatory cytokines including TNF-α, IL-6, IFN-γ and IL-1ß will be analyzed from Dried Blood Spots (DBS)
Time frame: Day 0 baseline, 10 months
Change in pro-inflammatory transcription factor activation
Changes in pro-inflammatory transcription factor activation including NF-κB/Rel will be analyzed from Dried Blood Spots (DBS)
Time frame: Day 0 baseline, 10 months
Change in Substance Use
Changes in substance use and misuse measured by CRAFFT Adolescent Substance Use Screen (0-9, Higher scores indicate higher risk for substance misuse)
Time frame: Day 0 baseline, 10 months
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