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APCIPAdolescent BREATHE Primary Care Intervention for PTSD (PCIP) Randomized Feasibility Trial

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What is being tested

Primary Care Intervention for PTSD (PCIP)

+ Treatment As Usual

Behavioral
Who is being recruted

Trauma and Stressor Related Disorders+1

+ Mental Disorders

+ Stress Disorders, Post-Traumatic

From 12 to 22 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: January 2022
See protocol details

Summary

Principal SponsorUniversity of California, Los Angeles
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 3, 2022

Actual date on which the first participant was enrolled.

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.

Official TitleAdolescent BREATHE Primary Care Intervention for PTSD (PCIP) Randomized Feasibility Trial
NCT05088915
Principal SponsorUniversity of California, Los Angeles
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

44 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 12 to 22 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Trauma and Stressor Related DisordersMental DisordersStress Disorders, Post-TraumaticStress Disorders, Traumatic

Criteria

5 inclusion criteria required to participate
Patient referred to the SHARK Program

Patients must be at least 12 years old

Screened for probable PTSD on UCLA RI, or at provider discretion of clinical relevancy.

If patient is under 18 years old, the patient's legal guardian is able and willing to provide informed consent for the patient to participate in the study;

Show More Criteria

2 exclusion criteria prevent from participating
Suicidal ideation with a plan within the last two weeks or a suicide attempt within the past 30 days;

Inability to provide informed consent or assent, and/or complete procedures in English.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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).

Group II

Active Comparator
Receive standard care treatment and provided information on free or low cost mental health care referrals in the Los Angeles Area.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of California Los Angeles

Los Angeles, United StatesOpen University of California Los Angeles in Google Maps
SuspendedOne Study Center