Applying Mixed Methods to Identify Links Between PTSD Symptoms, Cannabis Use, and Functional Behaviors With Personalized Feedback Intervention Development

July 17, 2026 updated by: VA Office of Research and Development
Many Veterans live with posttraumatic stress disorder (PTSD) and use cannabis to manage distress, despite limited supportive evidence. Veterans with PTSD who use cannabis often struggle with sleep, physical activity, and social connection, which are factors critical to health and well-being. This project will use smartphones and wearable devices to track symptoms and daily behaviors in real time and provide personalized feedback to help Veterans understand and manage the impact of PTSD and cannabis use in their lives. The study will develop a motivational interviewing-based personalized feedback approach that uses real-time data to help Veterans make data-informed decisions about their mental health, cannabis use, and functional behaviors. Findings will support development of scalable, Veteran-centered tools to promote healthier coping, functional recovery, and quality of life, even if they are not currently in treatment. The goal is to develop supportive, real-time strategies that meet Veterans where they are and promote better outcomes across the VA healthcare system.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Posttraumatic stress disorder (PTSD) and cannabis use are highly prevalent among Veterans, frequently co-occurring in ways that compound impairment and reduce quality of life. Many Veterans use cannabis to manage PTSD symptoms despite limited empirical support. Although the 2023 VA/DoD Clinical Practice Guidelines advise against cannabis for PTSD, a significant proportion of Veterans continue to use it. Both PTSD and cannabis use independently impair psychosocial functioning, and their combined day-to-day impact remains poorly understood. This CDA-2 focuses on developing and refining a motivational interviewing (MI)-based, personalized feedback approach that uses real-time data to help Veterans better understand how cannabis use relates to PTSD symptoms and daily functioning, with the goal of supporting healthier coping and functional recovery. This project uses ecological momentary assessment (EMA) and wearable activity tracking to support the development and refinement of an MI-based personalized feedback session for Veterans with PTSD who use cannabis. This personalized, data-driven approach yields foundational tools for future VA implementation.

Sixty Veterans with PTSD and regular cannabis use will complete a 14-day EMA protocol (3 random prompts, 2 daily diaries per day) and Fitbit tracking. The study will use a phased design. Phase 1 (n=20) informs PFS development. Phase 2 (n=10) pilots the 1st iteration PFS. Using qualitative feedback from Phase 2 participants and experts, the 2nd iteration PFS will be developed and piloted with a single-arm design in Phase 3 (n=30). Phase 3 tests the 2nd iteration PFS with 1- and 3-month follow-up assessments. Similarly, qualitative feedback will be gathered from Phase 3 participants to further refine the PFS for use in a future VA Merit Award randomized clinical trial. Outcomes include real-time reports of PTSD symptoms, cannabis use episodes, and functioning domains, analyzed using multilevel and network models. This CDA-2 will generate the empirical and methodological foundation needed to support a future VA Merit Award focused on fully testing an MI-based personalized feedback session. The long-term goal is to build the foundation for scalable self-management tools that support functioning and recovery among Veterans with co-occurring PTSD and cannabis use within the VA healthcare system.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92161-0002
        • VA San Diego Healthcare System, San Diego, CA
        • Contact:
        • Principal Investigator:
          • Terrell A. Hicks, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. U.S. Military Veterans
  2. DSM-5 PTSD diagnosis verified by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
  3. Cannabis use at least once per week over the past 3 months
  4. If on psychotropic medication or in psychotherapy (excluding trauma-focused PTSD therapy; see exclusion criteria), regimen must be stable for =1 month
  5. English-speaking and reading
  6. Willing and able to use a smartphone and wearable device for 2 weeks

Exclusion Criteria:

  1. Severe substance use disorder (excluding cannabis), as acute withdrawal or other drug effects could confound data; mild/moderate non-cannabis disorders permitted with monitoring
  2. Lifetime diagnosis of schizophrenia or other primary psychotic disorder due to potential confounding of EMA responses
  3. Severe depression or high suicide risk; such Veterans will be referred for treatment and may be re-evaluated once stabilized
  4. Cognitive or neurodegenerative disorder impairing ability to use EMA tools (e.g., moderate/severe TBI or dementia)
  5. Veterans currently engaged in evidence-based trauma-focused therapy (e.g., CPT, PE, EMDR), will be excluded to isolate naturalistic symptom variability, as therapy can substantially impact PTSD symptoms; these individuals will be invited to re-contact the study post-treatment for consideration
  6. Lack of smartphone ownership

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Personalized Feedback Session (PFS)
30 Veterans will complete baseline assessments, 14 days of ecological momentary assessment (EMA) and wearable monitoring, and receive the refined, second-iteration Personalized Feedback Session (PFS). Participants will complete follow-up assessments at 1- and 3-months post-PFS to evaluate feasibility, acceptability, and preliminary efficacy on PTSD symptoms, cannabis use, and daily functioning.
Behavioral: Personalized Feedback Session (PFS)
The Personalized Feedback Session (PFS) is an MI-based, individualized brief intervention designed to help Veterans understand how their own PTSD symptoms, cannabis use behaviors, and daily functioning behaviors interact in real time. The PFS integrates baseline assessment data and 14 days of EMA and wearable (Fitbit) data to generate personalized visualizations and feedback aimed at reducing unhelpful, cannabis use, encouraging engagement in evidence-based supported PTSD management, and supporting improvements in functioning. The PFS will be delivered individually via secure VA Video Connect or in-person and will last approximately 60 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PTSD Checklist (PCL-5)
Time Frame: Baseline through 1- and 3-month follow-up
The PTSD Checklist for DSM-5 (PCL-5) will measure past month PTSD symptom severity. The PCL-5 is a 20-item self-report measure of PTSD symptoms that maps directly onto the DSM-5 criteria55. Veterans rate how much each problem has bothered them in the last 30 days on a 0 ("Not at all") to 4 ("Extremely") scale. Summed scores range from 0 to 80, with higher scores indicating greater symptom burden.
Baseline through 1- and 3-month follow-up
Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis Use Inventory (DFAQ-CU)
Time Frame: Baseline through 1- and 3-month follow-up
The Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis Use Inventory (DFAQ-CU) will assess multiple dimensions of cannabis use patterns, including frequency, age of initiation, and quantity consumed in various forms (smoked flower, vaping concentrates, edibles, etc.). The DFAQ-CU is a self-report measure that asks participants to estimate average number of cannabis use sessions per day, typical days per week, age at first use, and usual quantity consumed per session using common user-friendly units (e.g., joints/bowls, grams, milligrams THC).
Baseline through 1- and 3-month follow-up
Inventory of Psychosocial Functioning (IPF)
Time Frame: Baseline through 1- and 3-month follow-up
The Inventory of Psychosocial Functioning (IPF) is an 80-item self-report measure of PTSD-related functional impairment during the past 30 days. Items cover seven domains: romantic relationships, family relationships, work, friendships/socializing, parenting, education, and self-care. Each behavior is rated on a 7-point Likert scale (1 = "never/almost never" to 7 = "always/almost always"), with lower scores indicating poorer functioning.
Baseline through 1- and 3-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Terrell A. Hicks, PhD, VA San Diego Healthcare System, San Diego, CA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

December 31, 2031

Study Completion (Estimated)

December 31, 2031

Study Registration Dates

First Submitted

July 17, 2026

First Submitted That Met QC Criteria

July 17, 2026

First Posted (Actual)

July 23, 2026

Study Record Updates

Last Update Posted (Actual)

July 23, 2026

Last Update Submitted That Met QC Criteria

July 17, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RRD9-007-25W
  • IK2RD001926 (Other Grant/Funding Number: Department of Veterans Affairs)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data sets without personal identifiers will be generated. Any HIPPA identifiers, or combinations of variables that could be used for re-identification, will be excluded, as will any proprietary information. The plan does not include any access to individually identifiable or proprietary data. Therefore, this plan will ensure the protection of personal privacy, the confidentiality of individually identifiable private information, and the security of the proprietary data and information.

IPD Sharing Time Frame

One or more data sets without personal identifiers will be generated during the data analysis phase of this study. The data sets will include all data underlying any publications generated by this study and therefore these will be sufficient to reproduce or verify any published findings.

IPD Sharing Access Criteria

Requests for access must be made in writing signed by a requester from the United States and include an email address for delivery and an assurance that the recipient will not attempt to identify or re-identify any individual. The request should reference the publication underlying the request. Requests may be made to the Principal Investigator/lead point-of-contact for the publication. If the investigator leaves the VASDHS the requests may be sent to the Associate Chief of Staff for Research.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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