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Behavioral Intervention
Video and Text Messaging Intervention for PTSD and Opioid Use Disorder
N/A
Waitlist Available
Led By Kate Walsh, PhD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Not currently or about to be hospitalized for severe injuries, suicidality, or psychosis
Are 18 or older
Must not have
Those who cannot read and respond to questionnaires in English
Patients under age 18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week, 2 week, 3 week, 1 month
Awards & highlights
Summary
This trial aims to create and test a short video and text messaging intervention for survivors of sexual assault. The goal is to prevent the development or worsening of PTSD and opioid misuse among these individuals.
Who is the study for?
This trial is for survivors of sexual assault who are at risk of developing or worsening PTSD and opioid misuse. Participants should be receiving care from a Sexual Assault Nurse Examiner (SANE).
What is being tested?
The study tests two interventions: a brief video program called STAR delivered during SANE care, and TextSTAR, a text messaging program provided after the assault to help prevent PTSD and opioid misuse.
What are the potential side effects?
Since this trial involves educational videos and text messages rather than medication, traditional side effects are not expected. However, participants may experience emotional distress due to the sensitive nature of the content.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not in the hospital for severe injuries, thoughts of suicide, or severe mental health issues.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot read or respond to questionnaires in English.
Select...
I am under 18 years old.
Select...
I am not currently hospitalized for severe injuries, suicidal thoughts, or psychosis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 week, 2 week, 3 week, 1 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week, 2 week, 3 week, 1 month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Opioid Misuse
Change in Posttraumatic Stress Disorder
Secondary outcome measures
Alcohol use severity
Depression level
Drug use severity
+6 moreTrial Design
6Treatment groups
Experimental Treatment
Active Control
Group I: Video, Below ThresholdExperimental Treatment1 Intervention
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 II: Video, Above Threshold, TextExperimental Treatment2 Interventions
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 III: Video, Above Threshold, No TextExperimental Treatment1 Intervention
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 IV: No Video, Above Threshold, TextExperimental Treatment1 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 be randomized to receive the textSTAR intervention.
Group V: No Video, Above Threshold, No TextActive Control1 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.
Group VI: No Video, Below ThresholdActive Control1 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.
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Who is running the clinical trial?
University of Wisconsin, MadisonLead Sponsor
1,198 Previous Clinical Trials
3,162,214 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,503 Previous Clinical Trials
2,625,533 Total Patients Enrolled
Kate Walsh, PhDPrincipal InvestigatorUniversity of Wisconsin, Madison
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