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

Mitigating PTSD-CUD Among Women Presenting to Emergency Care After Sexual Assault: Testing a Digital Therapeutic Targeting Anxiety Sensitivity

This study is testing a digital therapy to see if it can help women who have been sexually assaulted and are at risk for PTSD avoid developing problems with cannabis use.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 68 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: University of Nevada, Las Vegas (Academic / other)
• Locations: 6 sites (Minneapolis, Minnesota and 5 other locations)
• Trial ID: NCT05989841 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are women aged 18 and older who have recently experienced sexual assault and report frequent cannabis use.

Not a fit: Patients who are currently pregnant, unable to provide informed consent, or have serious cognitive impairments may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly reduce the incidence of cannabis use disorder among women suffering from PTSD after sexual assault.

How similar studies have performed: While there is ongoing research in digital therapeutics for PTSD, this specific approach targeting PTSD-CUD in sexual assault survivors is novel and has not been extensively tested.

Eligibility criteria

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 this trial is running

Minneapolis, Minnesota and 5 other locations

• 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)
• Harbor Shelter — Smithfield, North Carolina, United States (Recruiting)
• Tulsa Forensic Nursing — Tulsa, Oklahoma, United States (Not_yet_recruiting)
• SAFE Austin — Austin, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Nicole A Short, PhD

Conditions Posttraumatic Stress Disorder; Cannabis Use Disorder