CA RCT Investigator Resource Page

Welcome to the RCT Investigator Resource Page. This page contains the resources and information that you will need as an investigator. If you need anything not provided on this page, please contact Tyler or Chris. Tyler is available to support you as an investigator and offer consultation about any issues that may arise during the study. Chris is available to assist with questions about participant scheduling and data collection.

• Tyler Orr

  • tyler@tylerorr.com

  • 423-284-3518

• Chris Cheung

  • research@constructedawareness.com

  • 954-536-9052

Purpose of the Study
The purpose of this randomized controlled trial (RCT) is to evaluate the effectiveness of Constructed Awareness in reducing trauma-related symptoms. Specifically, this study aims to assess the impact of CA on individuals experiencing trauma, comparing CA to treatment-as-usual to determine CA’s effectiveness in reducing trauma symptoms, as measured by the PTSD Checklist for DSM-5. The study will analyze pretest and posttest data. Key analyses will include within-subject changes, between-group comparisons, and interaction effects to assess CA’s impact on trauma symptoms relative to treatment-as-usual.

Research Questions

1. What is the effect of CA on trauma symptoms compared to the control group after controlling for baseline trauma symptoms?   

2. How do trauma symptoms change from pretest to posttest across both groups?   

3. Is there an interaction effect between group (CA vs. control) and time (pretest vs. posttest) on trauma symptoms?  

Implementation Details  
Participants will be recruited through CA-certified therapists and randomly assigned to either the experimental or control group using a computer-generated sequence. The experimental group will receive eight weekly, 50-minute CA treatment sessions focusing on resourcing and trauma processing. Control group participants will continue receiving TAU with their referring therapists for eight weeks. Both groups will complete pretest and posttest assessments. Posttest assessments will be emailed within one week of the final session to evaluate immediate outcomes. 

Steps for Recruiting Participants 

• Step One: Using snowball and convenience sampling, the investigators will initiate recruitment by contacting therapists within their professional network. 

• Step Two: Referring therapists will reach out to eligible clients using the Recruitment Script for Referring Therapists and the Recruitment Letter for Participants to provide study details. 

• Step Three: Interested participants will contact the research team via the email address provided in the Recruitment Letter for Participants. 

• Step Four: Once contacted, the research team will send the participant a Google Forms survey link containing the informed consent form, demographic form, and PCL-5. The informed consent form will include checkboxes for participants to confirm their consent and verify they meet the study’s inclusion criteria. Participants will complete the survey, which is expected to take approximately 15 minutes. All responses will be securely stored in a Google spreadsheet linked to a HIPAA-compliant Google account under a Business Associate Agreement (BAA). A BAA is a contract that ensures compliance with HIPAA regulations by defining how third-party vendors, such as Google, handle, protect, and safeguard protected health information (PHI) on behalf of the research team. Only approved research team members will have access to the data. 

• Step Five: Upon receiving the survey submission, eligibility will be verified. Eligible participants will be assigned a unique Participant ID#, which will be used for anonymity purposes. No identifying information will be linked to the Participant ID# besides organization during data collection phases. Participants meeting the eligibility criteria will be randomly assigned to either the treatment group or control group. Any submissions that do not meet the criteria will be excluded and not used for data analysis. The research team will send an exclusion email to non-eligible participants. All verification data collected will be used solely to confirm eligibility and will be destroyed after verification to ensure privacy. 

• Step Six: After verification, the survey responses associated with the Participant ID# will be entered into data analysis software for the purpose of organizing and analyzing the data. Only research team members with authorized access will handle the data. No identifying information will be included in the final dataset to maintain participant confidentiality.