Digital therapy for women with PTSD and cannabis use after sexual assault

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate a digital therapeutic intervention designed to mitigate the risk of developing cannabis use disorder (CUD) in women who have experienced sexual assault and are at risk for posttraumatic stress disorder (PTSD). The intervention will be tested for its acceptability and initial efficacy among women presenting for emergency care within 72 hours post-assault. Participants will receive either the RISE Guide or a Relaxation Control, and the study will also explore the underlying mechanisms of PTSD-CUD prevention. The research will contribute to the training of the lead investigator in conducting multisite randomized clinical trials and advanced statistical analyses.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Women sexual assault survivors presenting for emergency care \<72 hours post-assault at 1 of our 4 emergency care sites
2. English speakers
3. 18+ years of age
4. Able to provide informed consent
5. Have a smartphone with continuous service \>1 year
6. Report \>1x/weekly cannabis use on a substance use screener
7. Report elevated AS (\>17 on the Anxiety Sensitivity Index-3)

Exclusion Criteria:

1. Inability to provide informed consent (e.g., serious injury preventing the ability to hear, speak, or see to consent and participate, or other causes (e.g., diagnosed cognitive deficits, diagnosed dementia, asleep at time of screening)).
2. Prisoner
3. Currently pregnant
4. Lives with assailant and plans to continue to do so
5. Admitted patient
6. No mailing address
7. Previously enrolled
8. No sexual assault nurse examiner (SANE) examination
9. Reporting current plan and intent for suicide or homicide
10. Does not understand written and spoken English

Where it's running

• Harbor Shelter
  Smithfield, North Carolina, United States Recruiting
• SAFE Austin
  Austin, Texas, United States Recruiting
• Hennepin Assault Response Team
  Minneapolis, Minnesota, United States Not yet recruiting
• University Medical Center
  Las Vegas, Nevada, United States Not yet recruiting
• UNC Chapel Hill
  Chapel Hill, North Carolina, United States Not yet recruiting
• Tulsa Forensic Nursing
  Tulsa, Oklahoma, United States Not yet recruiting

Study contacts

• Study coordinator: Nicole A Short, PhD
• Email: nicole.short@unlv.edu
• Phone: 7028950606

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.