Mitigating PTSD-CUD After Sexual Assault

Conditions

• Cannabis Use Disorder
• Posttraumatic Stress Disorder

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• RISE Guide — 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 Control — 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.

Study Details

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.

Key Dates

Start date

Mar 14, 2024

Status verified

Jan 2026

Primary completion

Feb 28, 2027

Completion

Feb 29, 2028

Study Design

Enrollment

68 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: 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.
• Active Comparator: 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.

Primary Outcome Measure

Anxiety Sensitivity Index-3 (ASI-3) [ Time Frame: 6 weeks ]

Central Contacts

• Nicole A Short, PhD
  7028950606
  [email protected]

Locations (6)

Find similar trials in Minneapolis, MN

Related Studies

• Family Involvement in Treatment for PTSD (FIT-PTSD): A Brief, Feasible Method for Enhancing Outcomes, Retention, and Engagement
  Recruiting · VA Office of Research and Development · Boston, Massachusetts
• Respiratory Training in the Treatment of Transdiagnostic Pathological Anxiety
  Recruiting · University of Texas at Austin · Austin, Texas
• Enhancing Psychotherapy for Veterans and Service Members With PTSD and Anxiety
  Recruiting · Baylor College of Medicine · Houston, Texas
• Integration of Cognitive Processing Therapy and Relapse Prevention for Alcohol Use Disorder and PTSD
  PHASE2 · Recruiting · Texas A&M University · Charleston, South Carolina