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

Part of paid clinical trials in San Diego, California.

Sponsor
VA Office of Research and Development
Study ID
NCT07721285
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Marijuana Abuse
  • Stress Disorders, Post-Traumatic

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Jul 23, 2026
Start date
Jan 1, 2027
Status verified
Jul 2026
Primary completion
Dec 31, 2031
Completion
Dec 31, 2031

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

PTSD Checklist (PCL-5) [ Time Frame: Baseline through 1- and 3-month follow-up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA San Diego Healthcare System, San Diego, CASan DiegoCalifornia92161-0002
Terrell A Hicks, PhD
858-552-8585
Terrell A. Hicks, PhD (PRINCIPAL_INVESTIGATOR)

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