What is the mechanism of action of this treatment?

The most common treatments for Post-Traumatic Stress Disorder (PTSD) include trauma-focused psychotherapies such as Cognitive Processing Therapy (CPT) and Prolonged Exposure (PE) therapy, as well as pharmacologic treatments like selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs). Trauma-focused therapies work by helping patients process and integrate traumatic memories, reducing the power these memories have over their emotions and behaviors. SSRIs and SNRIs help by balancing neurotransmitters in the brain, which can alleviate symptoms of depression and anxiety. These treatments are crucial for PTSD patients as they address the core symptoms of the disorder, such as re-experiencing, avoidance, and hyperarousal. Specifically, targeting and reducing anxiety sensitivity, as studied in the RISE Guide trial, is important because it can lower the overall anxiety levels, making it easier for patients to engage in and benefit from other therapeutic interventions.

What side effects are associated with this type of intervention?

Common treatments for Post-Traumatic Stress Disorder (PTSD) include SSRIs, SNRIs, and cognitive-behavioral therapy (CBT). SSRIs can cause side effects such as nausea, headache, sexual dysfunction, and insomnia, while SNRIs may also lead to increased blood pressure and heart rate. CBT, especially trauma-focused CBT, generally has minimal physical side effects but can sometimes temporarily increase anxiety or distress as patients process traumatic memories. Combining these treatments can be effective, but the side effects of each should be carefully considered.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Post-Traumatic Stress Disorder (PTSD), primarily focusing on selective serotonin reuptake inhibitors (SSRIs) such as sertraline and paroxetine. These medications help reduce PTSD symptoms by modulating serotonin levels in the brain. Additionally, serotonin-norepinephrine reuptake inhibitors (SNRIs) like venlafaxine have shown efficacy in treating PTSD. While these treatments do not specifically target anxiety sensitivity, they help alleviate overall PTSD symptoms, which can include anxiety. The RISE Guide, which aims to reduce anxiety sensitivity, represents a novel approach that complements these existing pharmacological treatments.

What other types of research exist?

Promising novel alternatives to the RISE Guide for PTSD patients targeting anxiety sensitivity include: 1) A brief computerized intervention specifically focused on anxiety sensitivity, which has shown high acceptability and low drop-out rates among community participants and military veterans. 2) Self-guided digital treatment with virtual reality for panic disorder and agoraphobia, which includes psychoeducation and virtual reality exposure therapy (VRET) and has shown potential in easing the burden of anxiety-related disorders. Both interventions leverage digital platforms to provide accessible and effective treatment options.

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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

Must not have

Admitted patient

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 6

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the RISE Guide, an app designed to help women who have experienced sexual assault by reducing their anxiety and stress. It targets women receiving care shortly after the assault. The app gives personalized advice based on symptoms, while a wristband tracks physical stress responses to improve support.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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I speak English.

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 am currently admitted to a hospital.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Post-Traumatic Stress Disorder (PTSD) include trauma-focused psychotherapies such as Cognitive Processing Therapy (CPT) and Prolonged Exposure (PE) therapy, as well as pharmacologic treatments like selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs). Trauma-focused therapies work by helping patients process and integrate traumatic memories, reducing the power these memories have over their emotions and behaviors. SSRIs and SNRIs help by balancing neurotransmitters in the brain, which can alleviate symptoms of depression and anxiety. These treatments are crucial for PTSD patients as they address the core symptoms of the disorder, such as re-experiencing, avoidance, and hyperarousal. Specifically, targeting and reducing anxiety sensitivity, as studied in the RISE Guide trial, is important because it can lower the overall anxiety levels, making it easier for patients to engage in and benefit from other therapeutic interventions.

Generalizability of Pharmacologic and Psychotherapy Clinical Trial Results for Posttraumatic Stress Disorder to Community Samples.