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NCT Number: NCT07721285

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161-0002, United States

Location contact

Terrell A Hicks, PhD

CONTACT

[email protected]

(858) 552-8585 ext. 2736

Terrell A. Hicks, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Severe substance use disorder (excluding cannabis), as acute withdrawal or other drug effects could confound data; mild/moderate non-cannabis disorders permitted with monitoring
  • Lifetime diagnosis of schizophrenia or other primary psychotic disorder due to potential confounding of EMA responses
  • Severe depression or high suicide risk; such Veterans will be referred for treatment and may be re-evaluated once stabilized
  • Cognitive or neurodegenerative disorder impairing ability to use EMA tools (e.g., moderate/severe TBI or dementia)
  • 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
  • Lack of smartphone ownership

Treatment and study plan

Personalized Feedback Session (PFS)

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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).

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Terrell A Hicks, PhD

CONTACT

[email protected]

(858) 552-8585 ext. 2736

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Important dates

Study start
2027
Primary completion
2031
Study completion
2031
First posted
Jul 23, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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