Applying Mixed Methods to Identify Links Between PTSD Symptoms, Cannabis Use, and Functional Beha… (NCT07721285) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Applying Mixed Methods to Identify Links Between PTSD Symptoms, Cannabis Use, and Functional Behaviors With Personalized Feedback Intervention Development
United States60 participantsStarted 2027-01-01
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Exclusion criteria
. English-speaking and reading
. Willing and able to use a smartphone and wearable device for 2 weeks
. Severe substance use disorder (excluding cannabis), as acute withdrawal or other drug effects could confound data; mild/moderate non-cannabis disorders permitted with monitoring
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
PTSD Checklist (PCL-5)
Timeframe: Baseline through 1- and 3-month follow-up
2
Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis Use Inventory (DFAQ-CU)
Timeframe: Baseline through 1- and 3-month follow-up
3
Inventory of Psychosocial Functioning (IPF)
Timeframe: Baseline through 1- and 3-month follow-up
. 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