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Recruiting NCT06296186

Massed Prolonged Exposure for PTSD in Substance Use Treatment

No phase Interventional Stress Disorders, Post-Traumatic Substance Use Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Prolonged Exposure Therapy.
Who it may be relevant to
Registry conditions: Stress Disorders, Post-Traumatic, Substance Use Disorders. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Clinical Effectiveness and Implementation of Massed Prolonged Exposure for PTSD Among Veterans in Intensive Outpatient Substance Use Treatment (MPE)

Overview

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.

Detailed description

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).

Interventions

  • Behavioral Prolonged Exposure Therapy
    Exposure therapy for PTSD

Primary outcome measures

  • Clinician Administered PTSD Scale for DSM-5 (CAPS-5) [Time frame: At 4-, 16-, 28-, and 40-weeks post-first therapy session]
  • Time Line Follow back (TLFB) [Time frame: At 4-, 16-, 28-, and 40-weeks post-first therapy session]
  • Psychotherapy Completion Rates [Time frame: 16 weeks]
Secondary outcome measures (3)
  • Patient Health Questionnaire-9 (PHQ-9) [Time frame: At 4-, 16-, 28-, and 40-weeks post-first therapy session]
  • Brief Psychosocial Functioning Inventory (B-IPF) [Time frame: At 4-, 16-, 28-, and 40-weeks post-first therapy session]
  • Client Satisfaction Questionnaire-8 (CSQ-8) [Time frame: 16 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 4 centers
  • VA San Diego Healthcare System — San Diego
  • VA Tampa Healthcare System — Tampa
  • VA Atlanta Healthcare System — Atlanta
  • Hines VA Healthcare System — Chicago

Identifiers

NCT: NCT06296186 · HT94252310669

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗