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Behavioural Intervention

eHealth Intervention for PTSD after Sexual Assault (RISE Trial)

N/A

Waitlist Available

Led By Samuel A. McLean, MD, MPH

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

English speakers

18+ years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 6

Awards & highlights

RISE Trial Summary

This trial is testing a new digital therapeutic guide that could help reduce anxiety and posttraumatic stress for sexual assault survivors. If successful, it could be provided for free to all women who seek emergency care after sexual assault in the US.

Who is the study for?

This trial is for English-speaking women who survived a sexual assault within the last 72 hours, are seeking emergency care at participating locations, can consent, have had a smartphone with service for over a year, and are older than 18. It's not for those without a SANE exam, currently pregnant, living with their assailant without plans to leave, unable to consent due to serious injury or cognitive issues, prisoners, admitted patients or those without an address.Check my eligibility

What is being tested?

The RISE Study is testing the effectiveness of the RISE Guide digital therapeutic aimed at reducing anxiety sensitivity in female survivors of sexual assault. The study compares this new eHealth solution against standard relaxation control methods to see if it can help alleviate post-traumatic stress symptoms.See study design

What are the potential side effects?

Since this trial involves digital therapeutics rather than medication or invasive procedures, traditional physical side effects are not expected. However participants may experience emotional discomfort while engaging with content related to trauma as part of the therapy.

RISE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I speak English.

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I am 18 years old or older.

RISE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean Change from Baseline to Week 7 in Anxiety Sensitivity-3 (ASI-3) Score (Active vs. Control)

Mean Credibility/Expectability Questionnaire (CEQ) Score (Active vs. Control)

Mean PTSD Checklist for Diagnostic and Statistical Manual (DSM)-5 (PCL-5) Score (Active vs. Control)

+3 more

Secondary outcome measures

Mean Alcohol Use Disorder Identification Test (AUDIT; Active vs. Control)

Mean Fagerstrom Test of Nicotine Dependence (FTND; Active vs. Control)

Mean Patient-Reported Outcomes Measurement Information System (PROMIS)-Anxiety Score (Active vs. Control)

+2 more

Other outcome measures

Mean Cannabis Use and Frequency Score (Active vs. Control)

Mean Marijuana Cravings Questionnaire-Emotionality (MCQ) Score (Active vs. Control)

Percent of Participant above Clinically-Significant Cut-off for Composite International Diagnostic Interview Screening Scales (CIDI-SC)

+1 more

RISE Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: RISE GuideExperimental Treatment1 Intervention

The RISE (RCT for Innovating Stress-related eHealth) Guide is based on CAST, an anxiety sensitivity intervention effective in reducing anxiety sensitivity, posttraumatic stress, depression, and anxiety. RISE Guide delivers psychoeducation and cognitive-behavioral therapy principles in an interactive, audio-visual format discussing the stress response, myth-busting cognitive distortions related to stress, and facilitating safe exposure to feared sensations. Participants then complete a validated cognitive bias modification (CBM-I) for interpretation biases related to anxiety sensitivity. Finally, intervention principles are reinforced using ecological momentary intervention (EMI), in which surveys and personalized reminders are delivered based on symptoms reported during ecological momentary assessments (EMAs) RISE Guide delivered by smartphone via Qualtrics and is completed in ~45 minutes over 2 weeks, with EMI weeks 1-7 post-assault.

Group II: Relaxation ControlActive Control1 Intervention

Breathe2Relax is a mobile application that instructs users on diaphragmatic breathing, a coping tool in which slow breathing through the diaphragm reduces anxiety. Participants in the control condition will download Breathe2Relax to their smartphones and receive short message service (SMS) reminders to engage with the app. The control intervention is expected to reduce symptoms, but not as much as the cognitive-behavioral therapy strategies taught in RISE Guide.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

RISE Guide

2021

N/A

~60

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor

1,504 Previous Clinical Trials

4,187,602 Total Patients Enrolled

Mayday FundOTHER

12 Previous Clinical Trials

1,270 Total Patients Enrolled

Samuel A. McLean, MD, MPHPrincipal InvestigatorUniversity of North Carolina, Chapel Hill

Media Library

RISE Guide (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05305235 — N/A

Post-Traumatic Stress Disorder Research Study Groups: RISE Guide, Relaxation Control

Post-Traumatic Stress Disorder Clinical Trial 2023: RISE Guide Highlights & Side Effects. Trial Name: NCT05305235 — N/A

RISE Guide (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05305235 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aggregate amount of participants in this medical experiment?

"Correct, the clinicaltrials.gov website indicates that this study is actively recruiting participants. It was first published on December 1st 2021 and updated lastly on November 1st 2022. The trial seeks 60 willing patients to enroll from two separate sites."

Answered by AI

Is this medical experiment currently searching for participants?

"The clinical trial is actively seeking enrolment, as evidenced by the information found on ClinicalTrials.gov; it was originally posted in December 2021 and has been updated most recently on November 2022."

Answered by AI

Which goals is this research initiative attempting to accomplish?

"This clinical trial will focus on assessing Mean Credibility/Expectability Questionnaire (CEQ) Score, with secondary outcomes being the Alcohol Use Disorder Identification Test (AUDIT), Percent of Participant above Clinically-Significant Cut-off for Marijuana Motives Measure (MMM), and Patient-Reported Outcomes Measurement Information System (PROMIS)-Anxiety Score. These evaluations are to be undertaken within a 1 week period in order to measure reductions in anxiety sensitivity from initial evaluation through 12 months post treatment."

Answered by AI