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NCT07721285

Overview

NCT ID: NCT07721285
Lead Sponsor: VA Office of Research and DevelopmentFED
Official Title: Applying Mixed Methods to Identify Links Between PTSD Symptoms, Cannabis Use, and Functional Behaviors With Personalized Feedback Intervention Development
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.

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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

Central Contacts: Terrell A Hicks, PhDContact
Terrell.Hicks@va.gov(858) 552-8585 ext. 2736