Clinical trial NCT06296186: Massed Prolonged Exposure for PTSD in Substance Use Treatment
Official title: Clinical Effectiveness and Implementation of Massed Prolonged Exposure for PTSD Among Veterans in Intensive Outpatient Substance Use Treatment (MPE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Substance Use Disorders
Lead sponsor: Veterans Medical Research Foundation
Sponsor class: OTHER
Collaborators: name: University of Minnesota
name: Center for Veterans Research and Education
First posted: 2024-03-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

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

Primary outcomes:
measure: Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
timeFrame: At 4-, 16-, 28-, and 40-weeks post-first therapy session
measure: Time Line Follow back (TLFB)
timeFrame: At 4-, 16-, 28-, and 40-weeks post-first therapy session
measure: Psychotherapy Completion Rates
timeFrame: 16 weeks
Secondary outcomes:
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: At 4-, 16-, 28-, and 40-weeks post-first therapy session
measure: Brief Psychosocial Functioning Inventory (B-IPF)
timeFrame: At 4-, 16-, 28-, and 40-weeks post-first therapy session
measure: Client Satisfaction Questionnaire-8 (CSQ-8)
timeFrame: 16 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System
state: California
city: Tampa
country: United States
facility: VA Tampa Healthcare System
state: Florida
city: Atlanta
country: United States
facility: VA Atlanta Healthcare System
state: Georgia
city: Chicago
country: United States
facility: Hines VA Healthcare System
state: Illinois
Study officials:
affiliation: University of Minnesota
name: Shannon Kehle-Forbes, PhD
role: PRINCIPAL_INVESTIGATOR
References: