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

NCT07721285 | Not Yet Recruiting

• 2 other identifiers: RRD9-007-25WIK2RD001926
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stress Disorders, Post-Traumatic; Marijuana Abuse

Keywords

Cannabis; Ecological Momentary Assessment

Outcome Measures

Primary Outcomes (3)

• 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.

  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).

  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.

  Baseline through 1- and 3-month follow-up

Study Arms (1)

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.

Behavioral: Personalized Feedback Session (PFS)

Interventions

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.

Personalized Feedback Session (PFS)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161-0002, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Marijuana Abuse

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Officials

• Terrell A. Hicks, PhD

  VA San Diego Healthcare System, San Diego, CA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Terrell A Hicks, PhD

CONTACT

(858) 552-8585; Terrell.Hicks@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: July 23, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• 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.
• 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.

Locations

US (1)