Primary Objective: The primary intent of this study is to determine whether
Reconsolidation of Traumatic Memories (RTM) achieves a greater and/or more rapid response
than prolonged exposure (PE) in the treatment of military service members with PTSD. This
is an interventional randomized controlled trial in which all participants will receive
active psychotherapy for PTSD, either what is currently considered the best-evidenced
treatment, prolonged exposure, or a novel approach, reconsolidation of traumatic
memories, that the investigators believe can achieve a higher response rate that will
also prove more rapid and more durable. Participants will be active duty, reserve or
National Guard service members, or former service members who were retired either
medically or for length of service, who are eligible for care in the Department of
Defense Healthcare System. Our findings should be generalizable to current and former
military service members with PTSD.
Approach This is a randomized controlled trial, enrolling 108 SMs with active PTSD, to
RTM and PE, with up to 10 treatment sessions in each arm. The anticipated average
enrollment rate will be 2 new participants per week. Participants may be male and female
adult (ages 18+) participants who are active, reserve component, National Guard, or
retired SMs; those with active suicidal or homicidal ideation, or a history of a
psychotic disorder, will be excluded. Participants may have a history of lifetime mild or
moderate traumatic brain injury (TBI), or no TBI history, but no lifetime history of
severe TBI. Given that most participants are expected to be referred from the Center for
Neuroscience and Regenerative Medicine (CNRM)'s Military Recruitment Protocol, it is
anticipated that the great majority will have comorbid mild TBI (mTBI). All participants
will also complete a total of 5 assessment visits: at baseline, immediately after the
course of treatment, and at 2, 6 and 12 months. The baseline visit will begin with the
completion of informed consent, followed by the administration of a series of
questionnaires, a detailed neurocognitive assessment, and a blood draw; serial assessment
will occur throughout the intervention period and for 12 months of follow-up.
Participants will be randomly assigned to PE or RTM using a random number generator in MS
Excel or other program to generate a random sequence of 108 zeroes and ones as a list.
Subjects will be assigned to the treatment arms from that list: all zeros will be
assigned to RTM and ones to PE.
Hypotheses: Military service members with PTSD who are randomized to Reconsolidation of
Traumatic Memories (RTM) therapy will be significantly more likely to achieve PTSD
resolution than those randomized to Prolonged Exposure (PE) therapy, measured by the
Clinician-Administered PTSD Scale for DSM5 (CAPS-5, by expert assessors blinded to
treatment group assignment). The investigators also anticipate that RTM will achieve a
response more rapidly, and will prove more durable. Among the secondary measures that
will correlate with response to therapy are measures of depression, anxiety, sleep
quality, and overall functional status. Primary Aim: Compare response rates of PTSD to
RTM vs. PE, defined by remission of diagnosis on the CAPS-5, using a 2-tailed t-test,
from baseline to post-intervention. The investigators will also utilize repeated measures
ANOVA to compare CAPS-5 scores at baseline, post-intervention, and at 2-, 6-, and
12-month follow up within groups. In addition to this primary measure, the investigators
will also use independent sample t-tests to document the efficacy of randomization by
comparing the two groups' baseline CAPS-5 total scores, along with PCL5, PHQ-9, NSI,
GAD-7, PSQI, WHOQOL-10, number of TBIs, and all other demographic variables.
Secondary Aim 1: Corroborate impact on PTSD symptom severity by measuring changes in
CAPS-5 and PCL5, respectively, from baseline to post-treatment for RTM and PE, using a
2-tailed t-test. The investigators will then use repeated measures ANOVA to compare
within and between group changes in the CAPS-5 at baseline, post-treatment, 2-, 6-, and
12-month follow-up for the CAPS-5, and these as well as scores obtained prior to
treatment sessions 2, 4, 6, 8 and 10 for the PCL5.
Secondary Aim 2: Compare rapidity of improvement in PTSD symptom severity between RTM and
PE, measured by PCL5 scores at baseline, prior to treatment sessions 2, 4, 6, 8 and 10,
and post-treatment, using a log-rank test to compare Kaplan-Meier curves for two groups.
Secondary Aim 3: Compare the durability of response to treatment, with the primary
measure being the percentage meeting criteria for PTSD on the CAPS-5, at post-treatment,
and at 2-, 6-, and 12-month follow-ups, using repeated measures ANOVA between the two
groups. The investigators will also determine whether this is corroborated by symptom
severity reduction by comparing the CAPS-5 and PCL5 scores at these time points, again
using repeated measures ANOVA.
Secondary Aim 4: Compare the impact of RTM and PE upon comorbid conditions by using ANOVA
with Bonferroni adjustment for multiple comparisons, to compare scores at baseline,
post-treatment, and each of the follow-up time-points, on postconcussive symptoms (NSl),
depression (PHQ-9), anxiety (GAD-7), sleep (PSQI), and functional status (WHOQOL-100).