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Behavioral Intervention

Massed PE for Substance Use Disorder (PREVAIL Trial)

N/A

Waitlist Available

Led By Shannon Kehle-Forbes, PhD

Research Sponsored by Veterans Medical Research Foundation

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 4-, 16-, 28-, and 40-weeks post-first therapy session

Awards & highlights

PREVAIL Trial Summary

This trial aims to see if having multiple sessions of Prolonged Exposure Therapy for PTSD in a week is as effective as having one session per week for veterans with PTSD and substance use disorder in intensive

Who is the study for?

This trial is for veterans with PTSD and substance use disorder who are currently in intensive outpatient treatment. Participants will be asked to complete Prolonged Exposure Therapy, which requires attending either weekly sessions or multiple sessions per week.Check my eligibility

What is being tested?

The study is testing the effectiveness of Prolonged Exposure Therapy for PTSD when conducted in a massed format (multiple sessions weekly) compared to the standard once-a-week session schedule among veterans undergoing substance use treatment.See study design

What are the potential side effects?

Prolonged Exposure Therapy may cause temporary increases in distress due to recalling traumatic events, but it's designed to help reduce PTSD symptoms over time. It does not involve medication, so drug-related side effects are not expected.

PREVAIL Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 4-, 16-, 28-, and 40-weeks post-first therapy session

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 4-, 16-, 28-, and 40-weeks post-first therapy session

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 4-, 16-, 28-, and 40-weeks post-first therapy session for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Clinician Administered PTSD Scale for DSM-5 (CAPS-5)

Psychotherapy Completion Rates

Time Line Follow back (TLFB)

Secondary outcome measures

Brief Psychosocial Functioning Inventory (B-IPF)

Client Satisfaction Questionnaire-8 (CSQ-8)

Patient Health Questionnaire-9 (PHQ-9)

Side effects data

From 2017 Phase 4 trial • 223 Patients • NCT01524133

49%

Gastrointestinal

35%

Psychological

32%

Neurological

25%

Genitourinary

14%

Respiratory

13%

Muskuloskeletal

Increased Suicidal Ideation

Cardiovascular

dyspepsia

Endocrine

Dermatological

Increased Irritability

100%

80%

60%

40%

20%

Study treatment Arm

Prolonged Exposure + Sertraline (PE/SERT)

Sertraline + Enhanced Medication Management (SERT/EMM)

Prolonged Exposure + Placebo (PE/PLB)

PREVAIL Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Massed PEExperimental Treatment1 Intervention

Prolonged Exposure delivered in a massed format - sessions multiple times per week

Group II: Weekly PEActive Control1 Intervention

Prolonged Exposure delivered with weekly sessions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Prolonged Exposure Therapy

2008

Completed Phase 4

~860

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Veterans Medical Research FoundationLead Sponsor

43 Previous Clinical Trials

4,734 Total Patients Enrolled

University of MinnesotaOTHER

1,381 Previous Clinical Trials

1,588,775 Total Patients Enrolled

Center for Veterans Research and EducationOTHER

11 Previous Clinical Trials

1,290 Total Patients Enrolled

Frequently Asked Questions

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

In how many medical facilities is this examination being conducted?

"Currently, patient enrollment for this research is ongoing at 4 distinct sites. Notable locations include Chicago, Tampa, and Atlanta among others. Opting for a site in close proximity could reduce the need for extensive travel if you decide to participate."

Answered by AI

Is the recruitment for this study still ongoing at present?

"As per the details on clinicaltrials.gov, recruitment for this specific trial is currently not active. Initially shared on 5th January 2024 and last revised on 28th February 2024, no new participants are being sought at present. However, it's worth noting that there are a substantial number of other trials - precisely 667 - actively seeking candidates presently."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Massed Prolonged Exposure for PTSD in Substance Use Treatment

2024. "Massed Prolonged Exposure for PTSD in Substance Use Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06296186.

All > Post Traumatic Stress Disorder > Ptsd