Feasibility and Acceptability of Mobile Mantram Repetition Program for Veterans With PTSD (IVI 22-115)
Phase: NA
Conditions: PTSD
Sponsor: VA Office of Research and Development

Feasibility and Acceptability of Mobile Mantram 
Repetition Program for Veterans With PTSD 
(IVI 22-115)
NCT05998967 
August 12, 2021

1 
SPECIFIC AIMS 
Easily accessible interventions to address post-traumatic stress disorder (PTSD) can play critical role in 
reducing PTSD and associated symptoms in Veterans, especially for those who remain symptomatic after treatment 
with other evidence-based interventions, those who prefer complimentary and integrative therapies, or those who 
have difficulty accessing traditional face-to-face mental health services. The value of these programs is their ability 
to provide Veterans with more options in their recovery journey and to reach a broad range of Veterans across 
multiple settings, including remote rural contexts.  
The Mantram Repetition Program (MRP) is a meditation-based practice that consists of the repetition of a 
spiritual word, one-pointed attention, and slowing down. MRP has been shown to reduce stress in several high-risk 
populations, and two large randomized, controlled studies show that MRP reduces PTSD symptoms among 
Veterans. A brief, web-based, self-directed version of MRP has been developed to increase the accessibility of 
evidence-based PTSD treatment. This version of MRP was tested in a pilot study with undergraduate students, 
demonstrating its ease of use and success in getting students to engage with the practice. The proposed mixed 
method study will use the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework to 
evaluate the mobile MRP in Veterans with PTSD in two conditions: self-directed and with text/phone support. Data 
from this pilot study will inform the refinement of the MRP delivery strategy and the development of a full-scale trial 
to test its effectiveness and implementation outcomes, as well as barriers and facilitators, and other contextual 
factors. 
Aim 1. To assess the reach and implementation of the mobile Mantram Repetition Program using a mixed methods 
approach focusing on feasibility, acceptability, appropriateness, and facilitators of and barriers to program 
implementation. 
Aim 2. To compare Veterans who are self-directed users of mobile MRP versus Veterans who receive text and 
phone support in terms of engagement with the intervention and change in PTSD and associated symptoms.  

2 
 
 
BACKGROUND AND SIGNIFICANCE 
Posttraumatic stress disorder (PTSD) is common among US military Veterans (Gradus, 2007). Untreated, 
PTSD is chronic and highly impairing (Santiago et al., 2013) thus it is a high priority for the VA. Current evidence-
based treatments can be highly effective; nonetheless, many Veterans remain symptomatic even after successful 
treatment (Steenkamp et al., 2020). Further, many Veterans express a preference for alternative approaches or 
complements to other treatment strategies (Whitehead & Kligler, 2020). Consistent with the Hannon Act, both 
meditation and spiritually-based approaches are potentially important avenues for restoring Whole Health for 
Veterans. 
The Mantram Repetition Program (MRP) is a meditation-based approach that involves silent repetition of a 
spiritual word in combination with development of one-pointed attention and slowing down (Bormann et al., 2014). 
The MRP is a transdiagnostic intervention, with documented positive effects on a range of outcomes, including 
improved stress management among healthcare workers (e.g., Leary et al, 2018) and caregivers (e.g., Bormann et 
al., 2009) and better coping among individuals with HIV (e.g., Bormann et al., 2006). Importantly, two large 
randomized controlled trials with Veterans have demonstrated that MRP was associated with large effect 
size reduction symptoms of PTSD as well as increased spiritual well-being and reduced insomnia (Bormann et 
al., 2012, 2018). The MRP can be taught in person or remotely, including by use of pre-recorded videos or by 
clinicians, paraprofessional or lay people. For example, the MRP was recently applied to increase patient-centered 
care and decrease burnout in nurses via internet-based learning (Kostovich et al., 2021). Recent work in our lab 
demonstrated that MRP can be taught in a self-directed manner through a series of brief videos delivered via 
Qualtrics. This brief, self-guided, web-based version of MRP was implemented with an undergraduate student 
sample and showed good retention in the program (88% completed the full intervention and 87% completed the 
follow-up assessment). Mantram repetition was regularly utilized by 80% of the group, and 96% endorsed applying 
the concept of slowing down. On average, participants were practicing 4-5 days/week (Vannini, et al, 2021). These 
initial data on the feasibility and acceptability of this MRP implementation strategy show promise for use in 
Veterans, given the demand for a wide range of easily-accessible and complementary and integrative treatment 
options.  
eScreening is a web-based, patient-facing screening and information-provision system developed with 
Veteran and staff feedback that allows for the rapid capture of self-report data and has been shown to improve the 
quality of documentation and access to care (Pittman et al., 2019). Across multiple VHA facilities, eScreening has 
been utilized over 34,000 times with Veterans in Transition Care Management, primary care, and mental health 
settings; eScreening supports both screening and measurement-based deployment of evidence-based 
psychotherapy. In 2016, the eScreening program was named a Gold Standard Practice for diffusion throughout 
VHA by the Under-Secretary for Health (Elnahal et al., 2017). eScreening is available nationwide and is a promising 
platform for the delivery of MRP to Veterans. 
 
The goals of this study are to (1) better understand mobile MRP by measuring reach, feasibility, 
acceptability, appropriateness, barriers and facilitators; and (2) compare effectiveness (i.e., mantram use, 
PTSD and associated symptoms) of self-directed MRP (i.e., used without support from a facilitator) to 
supported MRP (i.e., text/phone support provided by a facilitator) in Veterans with PTSD using the existing 
VA eScreening platform for delivery of the program. 
 
This project is responsive to several HSR&D priorities. If successful, this program would enhance access to 
care, thereby increasing health equity through the utilization of virtual care. This project also targets PTSD and 
associated symptoms, including insomnia, important mental health issues prioritized by HSR&D. This project 
features meditation, which is of interest to an increasing number of Veterans and a potential component of the 
Whole Health approach, whereby Veterans may focus on overall wellness, including spirituality. Finally, this study 
uses eScreening, an electronic, self-report screening system, developed by our research group for data collection 
and access to the intervention videos.  Consistent with the aims of the SWIFT-IVI program, we will pilot an 
implementation strategy in preparation for a future fully-powered implementation trial with the aim of rapidly 
deploying the MRP into routine practice. 
 
 

3 
 
METHODS 
Study Design 
This study is a prospective, randomized trial assessing implementation and effectiveness outcomes of a 
brief, self-directed, web-based meditation training. We will employ a mixed-method convergent approach to collect 
and analyze data to inform future implementation of the MRP (Palinkas et al., 2019). 
 
Participants 
Participants will be 40 Veterans with PTSD residing in San Diego County, CA. These individuals will be 
recruited from VA clinics (self- and provider-referral) and through community outreach (e.g., advertisements). 
Eligibility is intentionally broad to approximate future real-world users of MRP. 
Inclusion: Veteran, 18 or older, primary clinical complaint of PTSD, ability to access internet-enabled smart 
phone, tablet, or computer. 
Exclusion: Cognitive impairment or mental health concerns that necessitate a higher level of care or interfere 
with the ability to consent or engage in study activities (serious mental illness, untreated alcohol or substance 
use disorder, serious suicidality or homicidality, marked cognitive impairment).  
 
Interventions 
MRP consists of four online training modules that were developed for a Veteran audience by Dr. Jill 
Bormann, the developer of the intervention. They cover the basic intervention components: choosing a mantram, 
slowing down, attentional control and habit formation. These videos were created in conjunction with PsychArmor, 
Inc., a non-profit organization that provides training to multiple sectors who support Veterans and are available via 
internet (refer to Letter of Support from Dr. Carie Rodgers). In the self-directed condition, enrolled Veterans will 
not be contacted unless they reach out using contact information in the weekly module. In the supported 
condition, Veterans will receive a daily text reminder to practice their mantram (e.g., “Did you find a moment to 
practice your mantram today? Please respond YES, NO or HELP if you would like to talk to one of our staff.”). 
Those who answer in the affirmative will receive praise and an offer of support (e.g., “Great job! A regular practice 
happens one day at a time!”). Those who answer in the negative will receive brief encouragement and an offer of 
assistance (e.g., “You can repeat your mantram at any spare moment. Would you like to speak with a trainer about 
working it into your day?”). A request for help will be followed by a personal text and call by study staff.  
 
Procedures 
Following provision of written informed consent and HIPAA authorization using a telehealth-based informed 
consent process, Veterans will confirm access to a study-compatible device (Internet-enabled smart phone, tablet 
or computer) and be administered a semi-structured interview (MINI) and brief cognitive screen (blind MoCA) via 
telephone by a trained Research Assistant (RA) to confirm eligibility.  If deemed eligible, the Veteran will be 
randomly assigned to one of two conditions: self-directed MRP or supported MRP. Veteran involvement then 
proceeds as follows: 
1. Veterans complete a brief assessment battery (see Measures) including demographics and mental health 
symptoms using eScreening. 
2. Veterans access the training videos via eScreening. 
a. Day 1: All complete a brief symptom screener (see Measures), watch a ~15-minute instructional 
video (#1) and answer comprehension and credibility questions about the video. 
b. Days 2-7: Supported condition only: They are prompted daily to engage in meditation practice and 
may receive support toward that end (see Interventions). 
c. Day 8:  All complete a brief symptom screener and questions about meditation practice, watch a ~15-
minute instructional video (#2), and answer comprehension questions about the video.  
d. Days 9-14: Supported condition only: Daily prompts/support. 
e. Day 15: All complete a brief symptom screener and questions about meditation practice, watch a 
~15-minute instructional video (#3), and answer comprehension questions about the video. 
f. Days 16-21: Supported condition only: Daily prompts/support. 
g. Day 22: All complete a brief symptom screener and questions about meditation practice, watch a 
~15-minute instructional video (#4), and answer comprehension questions about the video. 
h. Days 23-28: Supported condition only: Daily prompts/support. 

4 
 
3. Veterans complete a brief assessment battery about mental health symptoms and answer questions about 
the feasibility, acceptability, and appropriateness of mobile MRP (Weiner et al., 2017).  
  
Data Collection and Measures  
We will collect data for the reach, implementation, and effectiveness outcomes of RE-AIM (Glasgow et al., 
2019) as depicted in Table 1. In this study, we will not be focusing on the last two dimensions of RE-AIM (i.e., 
adoption and maintenance). The advantage of this mechanism for delivering MRP is that it is self-directed, requiring 
little or no support from providers, and utilized similarly to other VA apps (e.g., PTSD Coach); consequently, factors 
related to the providers’ adoption of mobile MRP are minimal.  Collection of data pertaining to maintenance is 
beyond the scope if this one-year study, but it will be an important factor to measure in the full-scale trial of this self-
directed adaptation of the delivery of MRP with or without support in Veterans with PTSD. 
 
Table 1.  Select RE-AIM Implementation Outcomes and their Assessment 
RE-AIM 
Definition  
Measure/Instrument 
Data source 
Reach  
 
The absolute number, 
proportion, and 
representativeness of 
participants 
Number of screenings 
Percent eligible/ineligible 
Refusal rate 
Characteristics of participants 
Study 
recruitment logs 
eScreening 
platform surveys 
Implementation  
 
 
How much and how well 
the MRP is implemented 
and how it is received by 
Veterans 
Acceptability of Intervention Measure (AIM) 
Intervention Appropriateness Measure (IAM) 
Feasibility of Intervention Measure (FIM)  
Credibility of MRP 
% of videos completed with comprehension 
Satisfaction with MRP 
Mantram use 
eScreening 
platform surveys 
Qualitative 
interview 
Effectiveness 
 
 
The impact of an 
intervention on Veteran 
outcomes 
Brief Symptom Screen 
PCL-5 
PHQ-9 
ISI 
Brief PHI 
eScreening 
platform surveys 
Screening 
The Mini International Neuropsychiatric Interview (MINI 7.0) (Sheehan et al., 1998) will be used to assess 
suicidality, substance dependence, and serious mental illness. Blind MoCA (Wittich, et al., 2010), which is a 
version of the Montreal Cognitive Assessment that can be used to assess for cognitive impairment via 
videoconferening, will assess cognitive readiness to participate. Demographic characteristics include age, 
gender, race/ethnicity, relationship status, years of education, SES/income/living situation, residential ZIP code, 
occupation/work status, branch of service/highest rank, service connection/disability status.  
Reach Measures 
The number of screenings, percent eligible/ineligible, and refusal rate will be calculated, and 
characteristics of participating Veterans with PTSD will be compared those who refuse or are ineligible and to 
clinical eScreening data from the facility to assess generalizability. 
Implementation Measures 
The Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and 
Feasibility of Intervention Measure (FIM) developed by Weiner et al, 2017) will be used to calculate mean ratings of 
acceptability, appropriateness, and feasibility. A Qualitative Interview will be used to collect additional qualitative 
data on the AIM, IAM, FIM using the interview guides that we have previously modified for use in our other studies 
(McCreight et al., 2019; Pittman et al., 2021). We will also explore barriers and facilitators of the implementation of 
MRP. Credibility ratings of the intervention will be assessed with three items adapted from Borkovec & Nau 
(1972). Ratings that are comparable to previous studies using mantram suggest that acceptability is retained in this 
format. Comprehension Questions will be module-specific and test the participants’ knowledge and understanding 
of each video. Using a conservative approach, we will not consider a video completed unless the comprehension 
question is answered successfully. The questions were developed for the Vannini et al. (2021) pilot of mobile MRP. 
Satisfaction will be assessed using a set of five-point Likert scale (1 =very dissatisfied; 5=very satisfied) items 
rating the module narrator, learning outcomes, overall course, and module content. The Mantram Use Scale, which 
has been used in several MRP efficacy studies, queries aspects of mantram use (frequency, practice/coping, 
sleep). 

5 
 
Effectiveness Measures 
A brief symptom screen (items 9-11 of the SF-12, Ware et al., 1996, anchored to the past week) will be 
used as a weekly indicator of mental state. The PTSD Checklist for DSM-5 version (PCL-5, Bovin et al., 2016) will 
be used to quantify PTSD symptoms over the past week. PCL-5 scores demonstrated good internal consistency (α 
= .96), test-retest reliability (r = .84), and convergent and discriminant validity (Blevins et al., 2015). The Patient 
Health Questionnaire depression items (PHQ-9; Kroenke et al., 2001) will be used to quantify depression severity. 
The PHQ-9 has strong internal consistency (0.74-0.81), validity, and demonstrated responsiveness to change (Titov 
et al., 2011). The Insomnia Severity Index (ISI; Bastien et al., 2001), a 7-item instrument that assesses the 
consequences of and distress related to insomnia, which is a common and impairing problem associated with 
PTSD. Research compared insomnia symptoms assessed with the ISI to weekly sleep diaries and overnight 
polysomnography for insomnia disorder and found a total score of ≥10 on the ISI indicates insomnia disorder in 
community samples with excellent internal consistency (Morin et al., 2011). The 21-item Brief Personal Health 
Inventory (Brief PHI; Department of Veterans Affairs, 2019) is a self-reflection tool that assesses all aspects of 
Whole Health corresponding to the Circle of Health (Department of Veterans Affairs, 2019). It consists of a series of 
closed and open‐ended questions that encourage Veterans to reflect on the multiple facets of health outlined in the 
Circle of Health and Well‐Being. Veterans are asked to rate their overall general physical well-being, 
mental/emotional well-being and daily life on a 1-5 scale, in which 1 = miserable and 5 = great. Current state (now) 
and ideal state (goal) functioning for each of the nine areas of the Circle of Health are rated. The Brief PHI has been 
recently used Almklov and colleagues (submitted) to characterize Veterans’ needs and preferences for services. 
 
Data Analysis 
Quantitative Analysis. Quantitative data from surveys and study databases will be summarized using 
descriptive statistics including frequencies, proportions, measures of central tendency (mean and median), and 
variability (standard deviation and interquartile range) along with data visualization methods, such as frequency 
tables, bar charts, line graphs, and scatter plots to understand implementation and effectiveness outcomes.  95% 
confidence intervals will be calculated when estimating proportions and means. Change from baseline to each post-
intervention on effectiveness measures and mantram use will be calculated overall and by group (self-directed vs 
supported). Wilcoxon signed rank test and rank sum test will be used to examine the change in each group and 
compare the change between two groups. Linear mixed effects model will be used to examine the trajectory of 
change from baseline to post-intervention.  
Qualitative analysis. Interviews will be recorded and transcribed. All qualitative data will be coded using a 
rapid qualitative data analytic approach. Unique and common themes across the two groups will be compared. Data 
analysis will be led by Drs. Rabin and Lindamer and will also include qualitatively-trained members of the research 
team.  
A matrix approach will be used to triangulate data from quantitative and qualitative sources. We will use a 
joint display analysis to support the integration of different data sources and types. Unique and common themes 
emerging across the two groups (self-directed and supported) will be identified and described. 
Sample size. As a feasibility study, the sample size was not projected to ensure enough study power for 
hypothesis testing. We assessed the effect size of the effectiveness measures (e.g., PCL-5) that can be detected 
with the planned sample size and 80% power. The effect size for change in outcome from baseline to post 
treatment in each intervention group and for overall was estimated based on a paired t-test. With a sample size of 
20 per group and 40 in total, we could detect an effect size of 0.66 and 0.45, which are moderate effect sizes. To 
compare the outcome change between the self-directed and supported groups, we could detect a large effect size 
of 0.91 for the difference with 20 subjects per group. This effect size would be clinically meaningful thus signaling 
the need for additional study. The sample size assessment was also conducted for assessing feasibility measures 
(e.g., initiation rate). First, we assessed the precision of estimates based on projected sample size. We considered 
a range of target rate from 0.60 to 0.90 and estimated the width of the 95% exact binomial confidence interval for 
overall and for each intervention group. If an estimated intervention initiation rate is 0.80, a sample size of 40 (total) 
and 20 (per intervention group) will produce a two-sided 95% confidence interval with a width of 0.243 and 0.335, 
respectively. If an estimated intervention initiation rate is 0.90, the width of the 95% CI is reduced (becomes more 
precise) with the same sample size projected above. 
 

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