NCT06456190

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 13, 2024

Completed
9 months until next milestone

Study Start

First participant enrolled

March 12, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2025

Completed
Last Updated

December 17, 2025

Status Verified

December 1, 2025

Enrollment Period

9 months

First QC Date

June 6, 2024

Last Update Submit

December 11, 2025

Conditions

Sexual ViolencePosttraumatic Stress DisorderOpioid UseOpioid Misuse

Outcome Measures

Primary Outcomes (2)

  • Change in Opioid Misuse

    Assessed using Tobacco, Alcohol, Prescription Medication, and Other Substance (TAPS) Tool. The TAPS tool is a brief, two-part assessment of substance use and misuse. The TAPS-1 is a screener with 4 items assessing frequency of use of tobacco, alcohol, prescription medication, and illicit substances. Any response other than "never" on the TAPS-1 indicates a positive screen, which leads to administration of the TAPS-2. The TAPS-2 is a brief assessment including 3-4 yes/no questions for each class of substances assessing level of use, dependence, and concern from others. Cut-offs for problematic substance use and substance use disorder are based on scores on the TAPS-2.

    1 week to 1 month

  • Change in Posttraumatic Stress Disorder

    Assessed using PTSD Checklist for DSM-5 (PCL-5). The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Scores range from 0-80, with scores of 31 or higher indicating probable PTSD.

    1 week to 1 month

Secondary Outcomes (9)

  • Tobacco, Alcohol, and Other Drug Use

    1 month

  • Opioid misuse severity

    1 month

  • Depression level

    1 month

  • Mindfulness skills usage

    1 week, 2 week, 3 week, 1 month

  • Perceived control over recovery process

    1 month

  • +4 more secondary outcomes

Study Arms (6)

Video, Above Threshold, Text

EXPERIMENTAL

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.

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

Video, Above Threshold, No Text

EXPERIMENTAL

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.

Behavioral: Skills Training in Active Recovery (STAR) Video

Video, Below Threshold

EXPERIMENTAL

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.

Behavioral: Skills Training in Active Recovery (STAR) Video

No Video, Above Threshold, Text

EXPERIMENTAL

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.

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

No Video, Above Threshold, No Text

NO INTERVENTION

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

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.

Interventions

Skills Training in Active Recovery (STAR) VideoBEHAVIORAL

a 12-15 minute video that includes psychoeducation about ptsd and substance misuse plus tips to not avoid safe but scary situations, cope with distress and urges to use, and engage with social support to aid recovery

Video, Above Threshold, No TextVideo, Above Threshold, TextVideo, Below Threshold
Text Skills Training in Active Recovery (TextSTAR) programBEHAVIORAL

a 3-week daily text program that includes supportive/empowering messages along with brief coping tips to not avoid safe but scary situations, cope with distress and urges to use, and engage with social support to aid recovery

No Video, Above Threshold, TextVideo, Above Threshold, Text

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen and nonbinary sexual assault survivors will be invited to participate
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticOpioid-Related Disorders

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Tape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevision

Study Officials

  • Kate Walsh, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2024

First Posted

June 13, 2024

Study Start

March 12, 2025

Primary Completion

December 3, 2025

Study Completion

December 3, 2025

Last Updated

December 17, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)