Testing STAR and TexSTAR: A Video and Text Messaging Intervention

NCT ID: NCT06456190

Last Updated: 2025-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-12

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Sexual Violence Posttraumatic Stress Disorder Opioid Use Opioid Misuse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Video, Above Threshold, Text

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.

Group Type EXPERIMENTAL

Skills Training in Active Recovery (STAR) Video

Intervention Type BEHAVIORAL

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

Text Skills Training in Active Recovery (TextSTAR) program

Intervention Type BEHAVIORAL

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

Video, Above Threshold, No Text

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.

Group Type EXPERIMENTAL

Skills Training in Active Recovery (STAR) Video

Intervention Type BEHAVIORAL

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, Below Threshold

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.

Group Type EXPERIMENTAL

Skills Training in Active Recovery (STAR) Video

Intervention Type BEHAVIORAL

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

No Video, Above Threshold, Text

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.

Group Type EXPERIMENTAL

Text Skills Training in Active Recovery (TextSTAR) program

Intervention Type BEHAVIORAL

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, No Text

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

No Video, Below Threshold

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Skills Training in Active Recovery (STAR) Video

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

Intervention Type BEHAVIORAL

Text Skills Training in Active Recovery (TextSTAR) program

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Wisconsin, Madison

OTHER

Sponsor Role lead

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kate Walsh, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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2024-0299

Identifier Type: -

Identifier Source: org_study_id

1R61DA059897-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

A487400

Identifier Type: OTHER

Identifier Source: secondary_id

L&S/PSYCHOLOGY/PSYCHOLOGY

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 8/28/2025

Identifier Type: OTHER

Identifier Source: secondary_id