Stress Disorders, Post-TraumaticNCT07721285
Applying Mixed Methods to Identify Links Between PTSD Symptoms, Cannabis Use, and Functional Behaviors With Personalized Feedback Intervention Development
A study testing Personalized Feedback Session (PFS) in people with Stress Disorders, Post-Traumatic and Marijuana Abuse, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stress Disorders, Post-Traumatic, Marijuana Abuse
- What is being tested?
- Personalized Feedback Session (PFS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2027to 31 Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161-0002
Terrell A Hicks, PhD, (858) 552-8585 ext. 2736, Terrell.Hicks@va.gov
Terrell A. Hicks, PhD
About this study
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.
Read the 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.
- Conditions
- Stress Disorders, Post-Traumatic, Marijuana Abuse
- Being tested
- Personalized Feedback Session (PFS)
- Keywords
- Cannabis, Ecological Momentary Assessment
- Medical subject headings
- Stress Disorders, Post-Traumatic, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Feedback Session (PFS)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Personalized Feedback Session (PFS) | Experimental | 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. Receives: Behavioral: Personalized Feedback Session (PFS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Checklist (PCL-5)
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.
Measured: Baseline through 1- and 3-month follow-up
Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis Use Inventory (DFAQ-CU)
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).
Measured: Baseline through 1- and 3-month follow-up
Inventory of Psychosocial Functioning (IPF)
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.
Measured: Baseline through 1- and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single-arm pilot evaluating feasibility, acceptability, and preliminary signal of efficacy of the personalized feedback session effect on PTSD symptoms, cannabis use, and functioning
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Terrell A. Hicks, PhD, Principal investigator, VA San Diego Healthcare System, San Diego, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07721285
- Sponsor's protocol ID
- RRD9-007-25W
- Other IDs
- IK2RD001926
- Status last verified
- Jul 2026
- First submitted
- 17 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applying Mixed Methods to Identify Links Between PTSD Symptoms, Cannabis Use, and Functional Behaviors With Personalized Feedback Intervention Development
- ClinicalTrials.gov ID
- NCT07721285
- Acronym / sponsor ID
- RRD9-007-25W
- Conditions
- Stress Disorders, Post-Traumatic, Marijuana Abuse
- Keywords
- Cannabis, Ecological Momentary Assessment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 23 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single-arm pilot evaluating feasibility, acceptability, and preliminary signal of efficacy of the personalized feedback session effect on PTSD symptoms, cannabis use, and functioning
| Arm | Type | Receives |
|---|---|---|
| Personalized Feedback Session (PFS) | Experimental | Behavioral: 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Personalized Feedback Session (PFS) |
Primary outcome
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.
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).
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Stress Disorders, Post-Traumatic
Active, not recruiting
Improving Student Mental Health Through a Universal Trauma-Informed Intervention
Anxiety Symptoms, Post-traumatic Stress Symptoms
RecruitingPhase 1
Open-Label Psilocybin Study in Transdiagnostic Population
Transdiagnostic, Depression - Major Depressive Disorder
Not yet recruitingPhase 2
Assessing of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies
PTSD, PTSD - Post Traumatic Stress Disorder
Active, not recruitingObservational study
Trauma-Related Attributions in Trauma Treatment: An Observational Study
PTSD
Not yet recruiting
Multimodal Intervention for Individuals With Posttraumatic Stress Disorder (PTSD) and Hazardous Alcohol Use
Post Traumatic Stress Disorder PTSD, Hazardous Alcohol Use
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Terrell A. Hicks, PhD principal investigator
VA San Diego Healthcare System, San Diego, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Feedback Session (PFS) in people with Stress Disorders, Post-Traumatic and Marijuana Abuse, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Terrell A Hicks, PhD ((858) 552-8585 ext. 2736, Terrell.Hicks@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Checklist (PCL-5) (time frame: Baseline through 1- and 3-month follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.