Massed Prolonged Exposure for PTSD in Substance Use Treatment

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2027-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this clinical trial is to learn if receiving Prolonged Exposure Therapy for PTSD in massed format (multiple sessions weekly) is as effective as receiving it with sessions once per week among veterans with PTSD and substance use disorder in intensive outpatient substance use treatment. The main questions it aims to answer are:

* Will the massed format help participants complete and benefit from Prolonged Exposure in terms of PTSD symptoms?
* Will it help participants reduce substance use? Participants who are in intensive substance use treatment will be asked to complete Prolonged Exposure with either weekly sessions or multiple sessions per week.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Hybrid 1 Effectiveness-Implementation Trial of Partner-Assisted Prolonged Exposure for PTSD

NCT06990191

Post Traumatic Stress Disorder

RECRUITING NA

The Efficacy of 90-Minute Versus 60-Minute Sessions of Prolonged Exposure for PTSD

NCT02720497

Posttraumatic Stress Disorder Combat Disorder

COMPLETED NA

Integrated vs Sequential Treatment for PTSD and Addiction

NCT01211106

PTSD Substance Addiction

COMPLETED NA

Mantram Repetition to Manage PTSD in Veterans

NCT00120627

Stress Disorders, Post Traumatic

COMPLETED NA

Mantram Repetition Meditation for Veterans With PTSD

NCT01506323

Stress Disorders, Post-Traumatic

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Posttraumatic stress disorder (PTSD) and substance use disorder (SUD) often co-occur. PTSD+SUD comorbidity is associated with more severe PTSD, worse treatment outcomes for substance use, greater suicide risk and worse functioning than having one of these disorders. First-line treatments for PTSD, particularly Prolonged Exposure Therapy (PE), are effective in treating PTSD among those with a SUD, and delivering these treatments concurrent to SUD programming is recommended by the VA/DoD Clinical Practice Guidelines. While PE is one of the most effective treatment options for PTSD among those with PTSD+SUD, effects are smaller and dropout is higher than among people with PTSD without a SUD. A promising way to enhance outcomes is to offer PE in a massed format (M-PE; i.e., multiple sessions per week instead of once weekly). M-PE has been shown to be effective in improving PTSD symptoms and substantially reducing dropout in military and Veteran populations. Preliminary findings suggest M-PE delivered concurrent to intensive SUD programming is a promising strategy that warrants further study. Evaluating the effectiveness of M- PE delivery in of SUD intensive outpatient programming (IOP) in improving PTSD and other mental health outcomes and reducing dropout as compared to weekly PE delivery (W-PE) is the necessary next step in this critical research.

The primary goal of this project is to determine if a promising way to treat PTSD among those with SUD, M-PE, will help Veterans with their PTSD symptoms and lead to better treatment completion rates more than PE delivered weekly and if the massed format will reduce substance use comparably to weekly PE among those in intensive SUD treatment. The study will also evaluate if M-PE helps Veterans function better and feel less depressed. M-PE is a one-on-one talk therapy that is delivered over twelve sessions several times a week. The therapy is brief because of the massed format so that it can be delivered at times when lengthy interventions may not be realistic, such as military mental health clinics on bases where military personnel may be getting ready to redeploy. The research team's preliminary work with Veterans in intensive SUD treatment showed M-PE to lead to improvements in PTSD and depression symptoms with no dropout, making this larger evaluation of M-PE compared to PE delivered in the traditional longer (weekly) format a critical next step. The study will accomplish this by randomly assigning participants who are in intensive SUD treatment to receive either M-PE or W-PE. The study will have 200 Veterans who served post 9/11 go through this study and the entire study is expected to take four years to complete. The study will run the study across four VAs (San Diego, Tampa, Chicago, and Atlanta).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stress Disorders, Post-Traumatic Substance Use Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Massed PE

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

Group Type EXPERIMENTAL

Prolonged Exposure Therapy

Intervention Type BEHAVIORAL

Exposure therapy for PTSD

Weekly PE

Prolonged Exposure delivered with weekly sessions

Group Type ACTIVE_COMPARATOR

Prolonged Exposure Therapy

Intervention Type BEHAVIORAL

Exposure therapy for PTSD

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Prolonged Exposure Therapy

Exposure therapy for PTSD

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Veterans
* age 18+
* who have served since September 2001
* who are enrolled in a SUD IOP at a participating VA
* meet DSM-5 criteria for a current SUD (Tobacco Use Disorder alone not sufficient for inclusion)
* meet DSM-5 criteria for PTSD
* report substance use at least 20 of the last 90 days
* are able to give informed consent.

Exclusion Criteria

* severe cognitive impairment
* current suicidal or homicidal intent requiring immediate treatment
* current unstable psychotic or manic symptoms not attributable to SUD

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No