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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
200
Exposure therapy for PTSD
VA San Diego Healthcare System
San Diego, California, United States
RECRUITINGVA Tampa Healthcare System
Tampa, Florida, United States
RECRUITINGVA Atlanta Healthcare System
Atlanta, Georgia, United States
RECRUITINGHines VA Healthcare System
Chicago, Illinois, United States
RECRUITINGNew Orleans VA Medical Center
New Orleans, Louisiana, United States
RECRUITINGCleveland VA
Cleveland, Ohio, United States
RECRUITINGClinician Administered PTSD Scale for DSM-5 (CAPS-5)
Measures PTSD symptom severity, score range 0-80, higher scores mean greater symptom severity
Time frame: At 4-, 16-, 28-, and 40-weeks post-first therapy session
Time Line Follow back (TLFB)
Measures percent days of alcohol or other drug use, score range 0-100%, higher scores indicate greater percent days of use
Time frame: At 4-, 16-, 28-, and 40-weeks post-first therapy session
Psychotherapy Completion Rates
Percent of participants completing all sessions of psychotherapy, range is 0-100%, higher number means greater percent completed therapy
Time frame: 16 weeks
Patient Health Questionnaire-9 (PHQ-9)
Depression symptom severity, range = 0-27, higher scores mean greater depression symptom severity
Time frame: At 4-, 16-, 28-, and 40-weeks post-first therapy session
Brief Psychosocial Functioning Inventory (B-IPF)
Measures severity of impairment in psychosocial functioning, scores = 0-100, higher scores indicate greater impairment
Time frame: At 4-, 16-, 28-, and 40-weeks post-first therapy session
Client Satisfaction Questionnaire-8 (CSQ-8)
Measures satisfaction with treatment, scores range from 8 to 32. higher scores indicate greater satisfaction with treatment
Time frame: 16 weeks
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