Pilot Study of Group Prolonged Exposure in Residential Treatment (CDA 15-251)
Phase: NA
Conditions: PTSD
Sponsor: VA Office of Research and Development

 
 
 
Optimizing Treatment Response in VA Specialized Intensive/Inpatient PTSD Programs 
NCT03533608 
February 12, 2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Scientific Narrative 
Group Prolonged Exposure  
PI Rebecca Sripada, PhD 
 
 
Abstract 
Objectives: Prolonged Exposure therapy (PE) is a first-line treatment for posttraumatic stress 
disorder (PTSD); however few VA patients receive this treatment. One of the barriers to PE 
receipt is that this treatment is only available in an individual (one-on-one) format, whereas 
many VA mental health clinics provide the majority of their psychotherapy services in group 
format. In particular, VA PTSD residential rehabilitation programs (RRTPs) offer most 
programming in a group format. Thus, the current study was designed to pilot test a group 
format of PE in RRTPs. 
 
Research Plan: We recruited 39 veterans who were engaged in care at the Battle Creek VA 
PTSD RRTP to participate in a Group PE protocol. 
 
Methods: Participants engaged in twelve 90-minute sessions of Group PE over the course of 6 
weeks. Treatment consisted of psychoeducation, rationale for treatment, and in vivo exposure to 
reduce trauma-related avoidance and thereby improve PTSD symptoms. PTSD symptoms were 
measured via the PTSD Checklist for DSM-5 (PCL-5) and depression symptoms were 
measured via the Patient Health Questionnaire (PHQ-9).  
 
Statistical Analysis Plan: We measured PTSD symptoms and depression symptoms at 
baseline, endpoint (6 weeks), and at 2-month follow-up.  
 
 

Background and Significance 
Prolonged Exposure therapy (PE) is a first-line treatment for posttraumatic stress 
disorder with the highest level of recommendation from the VA/DoD Clinical Practice 
Guidelines.1 Despite its efficacy, very few VA patients with PTSD receive this treatment. In 
residential PTSD programs, an average of 8% received PE in fiscal year 2012 (range 0–67%).2  
One of the barriers to PE receipt is that PE is only available in an individual (one-on-one) 
format, whereas many VA mental health clinics provide the majority of their psychotherapy 
services in group format. In particular, PTSD residential rehabilitation programs (RRTPs) offer 
most programming in group format. Perhaps as a result, cognitive processing therapy (CPT), a 
comparable trauma-focused treatment that is available in a group format, is provided 6 times 
more frequently than PE in residential care.2  In order to improve access to PE, the current 
study was designed to pilot test a group format of PE in RRTPs. 
 
Preliminary Studies and Current Status of the Field 
Promising preliminary evidence suggests that group PE is effective in outpatients.3,4 Co-
Investigator Dr. Erin Smith demonstrated that Group PE effectively reduced PTSD symptoms 
among 67 outpatient veterans.4 Group PE may enhance treatment response in several ways. A 
group format may provide unique validation and normalization from a group of peers who have 
experienced similar types of traumatic experiences.4,5 Group members may be motivated by 
improvement in their peers,4 or may feel more accountable to complete exposure homework 
assignments when they report homework completion in front of a peer group instead of 
reporting just to their individual therapist.4 A qualitative study of group PTSD treatment found 
that feedback and support from the group members was rated as the single most helpful 
component of therapy.6 Group PE may also be a more efficient way to utilize specialty trained 
staff resources.3 This could be particularly useful in PTSD-RRTPs, where PE offerings may be 
limited due to the scheduling constraints of staff. Thus, the current study was designed to test 
the feasibility of conducting this treatment in residential treatment participants. 
 
Research Design and Methods 
Sample. Thirty-nine veterans who were receiving treatment in the PTSD RRTP at the Battle 
Creek VA were recruited to participate in a Group PE protocol. It should be noted that N=30 was 
the median sample size per arm for trials with continuous outcome measures in a review of 79 
feasibility trials.7 Thus, a sample size of 39 provides adequate feasibility data for a fully-powered 
randomized controlled trial to be performed at the conclusion of this pilot.   
 
Inclusion/Exclusion Criteria. Inclusion and exclusion criteria were minimized and included 
only those factors that prevented the Veteran from benefiting from the current program. 
Inclusion criteria were current RRTP enrollment. Exclusion criteria were level of suicidal risk or 
severe cognitive impairment that in the judgment of the investigator made it unlikely that the 
patient could adhere to the study regimen. Eligible participants were offered participation in the 
study and those who agreed to participate reviewed consent forms with study staff.  
Goals and objectives. Consistent with recommendations for feasibility studies,8,9 the objectives 
of this study were to determine feasibility and acceptability of the intervention. We measured 
PTSD symptoms (PCL-5) and depression symptoms (PHQ-9) at baseline, endpoint (6 weeks), 
and at 2-month follow-up. 
 
Location of resources. The treatment was provided by existing RRTP providers. 
 
Staff training. Staff were trained in-person and through the provision of a treatment manual. All 
therapists had previously completed VA rollout training for PE. In addition to this training, Co-

Investigator Erin Smith provided an in-person therapist training session on Group PE. 
Therapists also received training on handling potential crisis situations and adverse events. 
Ongoing consultation was provided as needed.  
 
Treatment Manual. The RRTP Group PE treatment manual was adapted from the manual used 
in Smith et al., 2015.4 Therapists were provided with this manual to refer to after training. 
Therapists demonstrated proficiency via role play practice prior to delivering sessions to study 
participants. 
Treatment implementation and monitoring. Protocol adherence and participant-rated 
acceptability were monitored during the treatment.  All group sessions were audiotaped for the 
purposes of fidelity monitoring. 25% of tapes were randomly selected and coded by two 
independent raters on treatment adherence and therapist competence. Participant safety was 
continuously monitored. Participation in the study was discontinued if a participant experienced 
intolerable exacerbation of PTSD. 
 
Procedure. Participants engaged in twelve 90-minute sessions of Group PE over the course of 
6 weeks. Treatment consisted of psychoeducation, rationale for treatment, and in vivo exposure 
to reduce trauma-related avoidance and thereby improve PTSD symptoms.  
 
Participant process/feedback measures. Participants were administered the PCL-5 and 
PHQ-9 at baseline, 6-weeks, and 2-month follow-up. 
Expected Outcomes. The primary outcome measure was the PTSD Checklist (PCL-5) – a 20-
item self-report measure.10  
 
Statistical Analysis Plan As recommended in the feasibility study literature,11,12 descriptive 
statistics were performed to study the feasibility of the adapted treatment. Effect size estimates 
from small developmental studies generally have large standard errors and are unstable.13 
Therefore, analyses were limited to the calculation of means and standard deviations for 
primary outcome (PCL-5) and secondary outcome (PHQ-9) at baseline, endpoint, and 2-month 
follow-up.  
 
Future Directions. Determination of the feasibility of Group PE will enable a full-scale 
randomized controlled trial to test the effectiveness of this treatment.  
 
 

References 
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Department of Veterans Affairs and Department of Defense. VA/DoD Clinical Practice 
Guideline for the management of posttraumatic stress disorder and acute stress disorder. . 3.0 
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VA. The Long Journey Home XXI: Treatment of posttraumatic stress disorder (PTSD). 
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Sloan DM, Feinstein BA, Gallagher MW, et al. Efficacy of group treatment for 
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Smith ER, Porter KE, Messina MG, et al. Prolonged Exposure for PTSD in a Veteran 
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power calculations for study proposals. Arch Gen Psychiatry 2006;63:484-9.