Clinical trial NCT06456190: Testing STAR and TexSTAR: A Video and Text Messaging Intervention
Official title: Testing STAR and TextSTAR: A Video and Text Messaging Intervention for Recent Sexual Violence Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sexual Violence
Posttraumatic Stress Disorder
Opioid Use
Opioid Misuse
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-06-13
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This NIDA-funded HEAL Initiative: Opioid Use Disorder Care Pathways for Individuals with Histories of Exposure to Violence R61 seeks to develop and test a brief video intervention to deliver during Sexual Assault Nurse Examiner (SANE) care and a brief text messaging intervention to deliver in the month after the assault to prevent the onset or escalation of PTSD and opioid misuse among survivors of sexual assault.

Detailed description: This pilot trial is part of a larger R61/R33 to test the effectiveness of brief video and text messaging interventions on PTSD and opioid misuse among recent survivors of sexual assault presenting for medical care. In the R61 phase, researchers are working with a sexual assault advisory board to develop the video and text interventions. The research team is partnering with 5-6 Sexual Assault Nurse Examiner programs across the United States to recruit 50 participants. In this pilot trial, researchers aim to test the feasibility of recruitment strategies, acceptability of the interventions among survivors, and preliminary effectiveness of the interventions at addressing PTSD and opioid misuse.

Eligibility criteria: Inclusion Criteria:

* Are 18 or older
* Can read and respond to questions in English
* Are receiving a SANE exam for sexual assault victimization within the previous week (7 days)
* Not currently or about to be hospitalized for severe injuries, suicidality, or psychosis
* Not currently or about to be incarcerated

Exclusion Criteria:

* Patients under age 18
* Those who cannot read and respond to questionnaires in English
* Those seeking care that does not include a SANE exam
* Those who cannot consent to receive SANE care.
* Those who are currently or about to be hospitalized for severe injuries, suicidality, or psychosis
* Those who are currently or about to be incarcerated (e.g., suspects, those who have experienced sexual assault within a prison setting and are returning to that setting, etc)

Primary outcomes:
measure: Change in Opioid Misuse
timeFrame: 1 week to 1 month
measure: Change in Posttraumatic Stress Disorder
timeFrame: 1 week to 1 month
Secondary outcomes:
measure: Tobacco, Alcohol, and Other Drug Use
timeFrame: 1 month
measure: Opioid misuse severity
timeFrame: 1 month
measure: Depression level
timeFrame: 1 month
measure: Mindfulness skills usage
timeFrame: 1 week, 2 week, 3 week, 1 month
measure: Perceived control over recovery process
timeFrame: 1 month
measure: Opioid craving
timeFrame: 1 week, 2 week, 3 week, 1 month
measure: Pain severity
timeFrame: 1 week, 2 week, 3 week, 1 month
measure: Alcohol use severity
timeFrame: 1 month
measure: Drug use severity
timeFrame: 1 month
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Kate Walsh, PhD
role: PRINCIPAL_INVESTIGATOR
References: