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The study site preferred to conduct a non-randomized QI project
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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,
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BREATHE Primary Care Intervention for PTSD (PCIP) | Experimental | BREATHE PCIP is a treatment for Post-Traumatic Stress Disorder (PTSD) symptoms for use with individuals who have a diagnosis of PTSD or "probable PTSD." The treatment will be considered delivered when patients have learned and practiced breathing retraining and have discussed the symptoms of PTSD (Sessions 1 through 3). |
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| Treatment As Usual | Active Comparator | Receive standard care treatment and provided information on free or low cost mental health care referrals in the Los Angeles Area. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Primary Care Intervention for PTSD (PCIP) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in PTSD Knowledge | Changes in levels of PTSD Knowledge measured by the PTSD Knowledge Test (0-14, higher scores indicating more PTSD knowledge) | 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) | 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) | 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. | 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. | Day 0 baseline, 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Day 0 baseline, 10 months |
| Change in Trauma Symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lauren C Ng, PhD | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Los Angeles | Los Angeles | California | 90095 | United States |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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This study will utilize a hybrid effectiveness-implementation approach to conduct a randomized pilot feasibility trial of the PCIP screening and intervention protocol in adolescent primary care with two treatment arms:
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| Treatment As Usual | Behavioral | Receive standard care treatment and are provided information on free or low cost mental health care referrals in the Los Angeles Area. |
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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). |
| 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. | 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). | 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) | 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). | 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). | 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) | 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) | 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) | Day 0 baseline, 10 months |