Testing STAR and TexSTAR: A Video and Text Messaging Intervention

University of Wisconsin (UW)

Status: Enrolling

Conditions: Posttraumatic Stress Disorder; Sexual Violence; Opioid Use; Opioid Misuse

Treatments: Behavioral: Text Skills Training in Active Recovery (TextSTAR) program; Behavioral: Skills Training in Active Recovery (STAR) Video

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06456190

L&S/PSYCHOLOGY/PSYCHOLOGY (Other Identifier)

Protocol Version 1/18/2025 (Other Identifier)

2024-0299

1R61DA059897-01 (U.S. NIH Grant/Contract)

A487400 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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50 participants in 6 patient groups

Video, Above Threshold, Text

Experimental group

Description:

Participants in this condition will receive the STAR intervention video and those who are above threshold on PTSD or opioid misuse at 1 week will be randomized to receive the textSTAR intervention.

Treatment:

Behavioral: Skills Training in Active Recovery (STAR) Video

Behavioral: Text Skills Training in Active Recovery (TextSTAR) program

Video, Above Threshold, No Text

Experimental group

Description:

Participants in this condition will receive the STAR intervention video and those who are above threshold on PTSD or opioid misuse at 1 week will be randomized to not receive textSTAR.

Treatment:

Behavioral: Skills Training in Active Recovery (STAR) Video

Video, Below Threshold

Experimental group

Description:

Participants in this condition will receive the STAR intervention video and will be below threshold on PTSD and opioid misuse at 1 week and will not be randomized to receive further intervention.

Treatment:

Behavioral: Skills Training in Active Recovery (STAR) Video

No Video, Above Threshold, Text

Experimental group

Description:

Participants in this condition will not receive the STAR intervention video and those who are above threshold on PTSD or opioid misuse at 1 week will be randomized to receive the textSTAR intervention.

Treatment:

Behavioral: Text Skills Training in Active Recovery (TextSTAR) program

No Video, Above Threshold, No Text

No Intervention group

Description:

Participants in this condition will not receive the STAR intervention video and those who are above threshold on PTSD or opioid misuse at 1 week will not be randomized to receive the textSTAR intervention.

No Video, Below Threshold

No Intervention group

Description:

Participants in this condition will not receive the STAR intervention video and will be below threshold on PTSD and opioid misuse at 1 week and will not be randomized to receive further intervention.