Mitigating PTSD-CUD After Sexual Assault

NCT ID: NCT05989841

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-14
• Study Completion Date: 2028-02-29

Brief Summary

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.

Conditions

Posttraumatic Stress Disorder; Cannabis Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

RISE Guide

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.

Group Type: EXPERIMENTAL

RISE Guide

Intervention Type: BEHAVIORAL

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.

Relaxation

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.

Group Type: ACTIVE_COMPARATOR

Relaxation Control

Intervention Type: BEHAVIORAL

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.

Interventions

RISE Guide

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.

Intervention Type: BEHAVIORAL

Relaxation Control

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Hennepin HART

UNKNOWN

Sponsor Role: collaborator

Tulsa Police Department Forensic Nursing

UNKNOWN

Sponsor Role: collaborator

SAFE Austin Harbor Shelter

UNKNOWN

Sponsor Role: collaborator

University of Nevada, Las Vegas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hennepin Assault Response Team

Minneapolis, Minnesota, United States

Site Status: NOT_YET_RECRUITING

University Medical Center

Las Vegas, Nevada, United States

Site Status: NOT_YET_RECRUITING

UNC Chapel Hill

Chapel Hill, North Carolina, United States

Site Status: NOT_YET_RECRUITING

Harbor Shelter

Smithfield, North Carolina, United States

Site Status: RECRUITING

Tulsa Forensic Nursing

Tulsa, Oklahoma, United States

Site Status: NOT_YET_RECRUITING

SAFE Austin

Austin, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Nicole A Short, PhD

Role: CONTACT

nicole.short@unlv.edu

7028950606

Facility Contacts

Jeffrey Ho, MD

Role: primary

jeffrey.ho@hcmed.org

(612) 873-5832 ext. 2

Jordana Haber, MD

Role: primary

jordana.haber@unlv.edu

(702) 383-2000

Karen Serrano, MD

Role: primary

kserrano@email.unc.edu

(919) 966-6442

Laurie Mayenschein

Role: primary

lmayenschein@harborshelter.org

919-628-3380

Kasey Magness, BSN

Role: primary

kmagness@cityoftulsa.org

9187435763

Jenny Black, BSN

Role: primary

jblack@safeaustin.org

512.267.7233

Other Identifiers

1K23DA054299-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UNLV-2023-649

Identifier Type: -

Identifier Source: org_study_id