Mitigating PTSD-CUD After Sexual Assault (RISE-C)

Nevada System of Higher Education (NSHE)

Status: Enrolling

Conditions: Posttraumatic Stress Disorder; Cannabis Use Disorder

Treatments: Behavioral: Relaxation Control; Behavioral: RISE Guide

Study type: Interventional

Funder types: Other

Identifiers

NCT05989841

UNLV-2023-649

Details and patient eligibility

About

683,000 women are sexually assaulted annually in the United States, half of whom develop chronic posttraumatic stress disorder (PTSD) and thus have markedly increased risk for cannabis use disorder (CUD). The current proposal will test the acceptability, initial efficacy, and mechanisms underlying a novel digital therapeutic targeting risk for PTSD-CUD, which could address the critical need for PTSD-CUD prevention for the 100,000 women who annually present for emergency care after sexual assault. In this research context, the applicant will receive key training in multisite, emergency-care based randomized clinical trials (RCTs), advanced statistical analyses for RCTs and ecological momentary assessment data, biobehavioral mechanisms underlying PTSD-CUD prevention, and professional development, launching her independent research career focused on reducing the public health burden of PTSD-CUD among sexual assault survivors by leveraging digital therapeutics.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

RISE Guide

Experimental group

Description:

Brief cognitive behavioral intervention completed in the 3 weeks post-assault delivered via Internet on participants' smartphones targeting anxiety sensitivity, or fear of anxious arousal. Patients learn psychoeducation regarding the nature of stress, cognitive retraining to reduce negative interpretations of stress, and how to complete interoceptive exposures to reduce anxiety sensitivity. These skills are supported by 6 concurrent then subsequent weeks of ecological momentary intervention to deliver personalized intervention reminders based on symptoms.

Treatment:

Behavioral: RISE Guide

Relaxation

Active Comparator group

Description:

Patients will download the "Breathe2Relax" app, which delivers information about how to use diaphragm breathing (taking slow, deep breaths through the diaphragm) to manage stress. Participants will receive reminders to engage with the intervention. Participants will also receive ecological momentary intervention reminders to engage with the relaxation intervention.

Treatment:

Behavioral: Relaxation Control