Adaptation of Mindfulness Training to Treat Moral Injury in Veterans
Phase: PHASE3
Conditions: Mindfulness, Educational Support
Sponsor: Old Dominion University

 
 
Adaptation of Mindfulness Training to Treat Moral Injury in Veterans 
 
May 22, 2023 
 
NCT Number: NCT05341882 

 
Statistical Design and Power  
 
The goal of the proposed R34 is to adapt the MMCP program for combat wounded veterans with moral injury 
and compare its acceptability, adherence, and implementation/practicality to an equally intensive online, 
facilitator-led, interactive education support group comparison condition. We will also collect data to identify 
potential primary and second outcome measures for a future sufficiently powered RCT.  
 
Design 
Aim 1: Adapt MMCP to Address Moral Injury (Study 1)  
Study 1 is designed to adapt an existing mindfulness program to be appropriate for moral injury via an 
iterative developmental process based on existing literature and our previous research. For instance, we will 
make some key modifications to the mindfulness content to be appropriate for those with moral injury, including 
a self-compassion/loving kindness exercise based on previous research.149 We will also obtain information and 
feedback from stakeholders (veterans, mental health providers). To achieve this objective, the PI and co-Is will 
have monthly meetings to develop and adapt the program content. We will ask for feedback from moral injury 
researchers and providers including members of APA’s Division 19 Moral Injury Think Tank (chaired by the PI) 
for which they will receive small renumeration.  
As part of Study 1, Dr. Butler (consultant/interventionist) will provide the six 75-minute weekly audiotaped 
MMMI program sessions to six eligible participants. Upon completion of the MMMI program, semi-structured 
interviews will be conducted utilizing a post-positivist paradigm,150 guided by awareness that combat wounded 
veterans are a diverse population, have different experiences with moral injury, and may have different program 
reactions. All interviews will be conducted by the PI and GRA. The GRA and graduate and undergraduate lab 
members (many of whom are student veterans given the PI’s focus on veteran mental health and the large 
student veteran population at the PI’s university in Norfolk, VA), will transcript videotapes and develop initial 
coding themes. These themes will be reviewed by the research team and lead to MMMI refinement and 
preliminary manualization.    
Aim 2: Examine the Intervention’s Feasibility, Acceptability, and Preliminary Efficacy (Study 2)  
In Study 2, we propose to test our ability to recruit and retain participants, to implement the designed protocol, 
and to determine treatment adherence of the refined MMMI intervention as compared to a facilitator-led ES 
comparison group (N = 20 combat wounded veterans; 10 MMMI; 10 ES). The two groups (MMMI and ES) will 
not differ in the delivery (i.e., live facilitator led interactive web-based, number of sessions, length of sessions, 
and have manualized treatments). Further, some content will be identical (e.g., introductions, icebreakers) or 
similar (e.g., benchmarks, semi-structured interview). We will gather audiotaped semi-structured interviews and 
brief benchmark measures to assess the feasibility, acceptability, participant comments and suggestions, as well 
as and participant acceptance, satisfaction, and compliance data. See Table 1. 
Because there is no treatment-as-usual comparable to MMMI, several factors guided our decisions in 
developing the control group. In a different patient population, co-I Gaylord developed and compared an ES 
group to a mindfulness training group. Although the mindfulness group developed specific mindfulness skills, the 
two groups did not differ in their ratings of the credibility of their assigned interventions.142 Also, an active control 
condition provides a stronger study design.151 Third, treatment of the control condition should only differ from the 
experimental condition in the ‘non-receipt’ of the ‘active ingredient’.152 Also, 59% of veterans who took part in a 
Wounded Warrior Project survey reported talking with other veterans “as a top resource for coping with stress”.153 
Finally, researchers have provided moral injury treatment in weekly group meetings.65,99   
Aim 3. To Evaluate the Preliminary Feasibility of the Interventions (Study 3)    
In Study 3, we propose to test the refined interventions with a larger group of combat wounded veterans (N 
= 60 combat wounded veterans; 30 MMMI; 30 ES group). After completing the baseline measures, participants 
will be randomly assigned to program. We will collect information on acceptability, adherence, and 
implementation/practicality in the two intervention arms, as well as primary moral injury symptoms (e.g., guilt, 
shame), possible mechanisms of changes (e.g., acceptance, nonjudgment, compassion), and possible 
secondary outcomes (e.g., mental health symptoms, substance use), which will help inform key variables to 
include in a large-scale sufficiently powered RCT. See Table 3.  
  
Sample Size Determination  
Prior to determining the sample size for Study 3, we examined the literature on determination of sample size 
for feasibility studies.155-157 We specifically examined prior eligibility, refusal, randomization and session and data 
completion rates. We also considered practical aspects such as eligibility criteria, refusal and dropout rates, 

expected interview and data completion rates, therapist hours and length of training, supervision, fidelity coding, 
and timeline. Overall, the majority of feasibility studies had modest sample sizes with varying rates of participation 
completion: 57% (n = 21),107 81% (n = 33),97 and 77% (n = 37).110 Based on averages from previous 
studies,97,107,110 we will recruit 60 combat wounded veterans. Furthermore, we expect an ineligible rate/refusal 
rate of 30% (n = 18) and that an additional 18.8% (n = 8) will attend no sessions and/or not complete the post-
training semi-structured interview or other survey measures, for a conservative completion rate of 34 participants. 
Given that the MMMI and ES support group will be equal in delivery, facilitation, group size, length, home practice 
burden, we do not anticipate different group completion rates.   
Aim 2: Examine the Intervention’s Feasibility, Acceptability, and Preliminary Efficacy (Study 2)  
In Study 2, we propose to test our ability to recruit and retain participants, to implement the designed protocol, 
and to determine treatment adherence of the refined MMMI intervention as compared to a facilitator-led ES 
comparison group (N = 20 combat wounded veterans; 10 MMMI; 10 ES). The two groups (MMMI and ES) will 
not differ in the delivery (i.e., live facilitator led interactive web-based, number of sessions, length of sessions, 
and have manualized treatments). Further, some content will be identical (e.g., introductions, icebreakers) or 
similar (e.g., benchmarks, semi-structured interview). We will gather audiotaped semi-structured interviews and 
brief benchmark measures to assess the feasibility, acceptability, participant comments and suggestions, as well 
as and participant acceptance, satisfaction, and compliance data. See Table 1. 
Because there is treatment-as-usual comparable to MMMI, treatment-as-usual comparable to MMMI, 
several factors guided our decisions in developing the control group. In a different patient population, co-I 
Gaylord developed and compared an ES group to a mindfulness training group. Although the mindfulness 
group developed specific mindfulness skills, the two groups did not differ in their ratings of the credibility of 
their assigned interventions.142 Also, an active control condition provides a stronger study design.151 Third, 
treatment of the control condition should only differ from the experimental condition in the ‘non-receipt’ of the 
‘active ingredient’.152 Also, 59% of veterans who took part in a Wounded Warrior Project survey reported 
talking with other veterans “as a top resource for coping with stress”.153 Finally, researchers have provided 
moral injury treatment in weekly group meetings.65,99   
 
 
Aim 3. To Evaluate the Preliminary Feasibility of the Interventions (Study 3)    
In Study 3, we propose to test the refined interventions with a larger group of combat wounded veterans (N = 60 
combat wounded veterans; 30 MMMI; 30 ES group). After completing the baseline measures, participants will 
be randomly assigned to program. We will collect information on acceptability, adherence, and 
implementation/practicality in the two intervention arms, as well as primary moral injury symptoms (e.g., guilt, 
shame), possible mechanisms of changes (e.g., acceptance, nonjudgment, compassion), and possible 
Table 1. Measurable Benchmarks Administered during Study 2 and 3  
Area of Interest 
Description of Outcome to be 
Evaluated 
Measure and/or Expected Outcome 
Acceptability 
Participant Satisfaction  
Client Satisfaction Questionnaire (CSQ-8)154 satisfaction 
of ≥80% 
Intention to continue to use skills  
Questionnaire developed for this study 
Training appropriateness   
Questionnaire developed for this study 
Demand 
Completed sessions  
~52% of those who meet eligibility criteria will attend 4 to 
6 sessions based on previous studies97,107,110  
Homework Practice 
Gradual increase in minutes of home practice relative to 
the number of minutes assigned over the 6 weeks  
~40% of those who attend 4 to 6 sessions will complete 
80% or more homework  
Implementation/ 
Practicality 
Screening/eligibility for study/ 
dropout 
Record number of call attempts for each participant and 
reasons for ineligibility/decision not to participate/dropout 
Recruitment 
Recruit, phone screen, and explain study to eligible 
participants for Study 1 within 2 weeks, Study 2 within 1 
month, and Study 3 within 2 months. Obtained signed 
informed consent from participant.   
Retainment 
Among those randomized, 34/42 (81%) will attend 1 or 
more sessions97,107,110   
Assessment completion 
For assessments attempted, 90% completion rate 

secondary outcomes (e.g., mental health symptoms, substance use), which will help inform key variables to 
include in a large-scale sufficiently powered RCT. See Table 3.  
  
 
Sample Size Determination  
Prior to determining the sample size for Study 3, we examined the literature on determination of sample size 
for feasibility studies.154-156 We specifically examined prior eligibility, refusal, randomization and session and data 
completion rates. We also considered practical aspects such as eligibility criteria, refusal and dropout rates, 
expected interview and data completion rates, therapist hours and length of training, supervision, fidelity coding, 
and timeline. Overall, the majority of feasibility studies had modest sample sizes with varying rates of participation 
completion: 57% (n = 21),107 81% (n = 33),97 and 77% (n = 37).110 Based on averages from previous 
studies,97,107,110 we will recruit 60 combat wounded veterans. Furthermore, we expect an ineligible rate/refusal 
rate of 30% (n = 18) and that an additional 18.8% (n = 8) will attend no sessions and/or not complete the post-
training semi-structured interview or other survey measures, for a conservative completion rate of 34 participants. 
Given that the MMMI and ES support group will be equal in delivery, facilitation, group size, length, home practice 
burden, we do not anticipate different group completion rates.   
Aim 2 and 3: Examining the Intervention’s Fidelity, Feasibility and Acceptability  
Maintenance and Evaluation of Treatment Fidelity. We will provide ongoing assessment of treatment fidelity 
among facilitators following recommendations made by Borrelli174. Specifically, facilitators will utilize a treatment 
manual that will detail session-specific components and proscribed topics, along with a checklist to ensure 
completion. Contact minutes per group will be recorded to ensure duration consistency across groups. 
Deviations from protocol will be recorded by the facilitators. Further, all sessions will be audio-recorded via state-
of-the-art Intelligent Video Solutions equipment (see Equipment). Dr. Gaylord or Vinci will listen to at least one 
session per cohort group to ensure adherence to the manual across time and sessions. If either facilitator falls 
below a predetermined performance criterion or self-reported checklist indices, two sessions per group for that 
facilitator will be observed until adherence meets established criteria. Facilitators will be provided feedback 
during weekly supervision.  
Evaluation of Feasibility and Acceptability. To evaluate feasibility and acceptability, we will rely on 
benchmarks proposed in the extant pilot/feasibility study literature.176-178 Specifically, we will assess 
methodological- (screening, recruitment, randomization, retention) and intervention- (treatment adherence) 
related components of the proposed protocol. Throughout recruitment and administration, we will assess for: (1) 
the number of veterans screened per week, (2) the number of veterans enrolled per week, (3) the proportion of 
screened participants who take part in the sessions, (4) the ability to randomize enrolled veterans, (5) the number 
of battery assessments completed, and (6) the proportion of questionnaires completed. Low rates could indicate 
a high level of perceived burden, limiting the feasibility of this intervention. 
Specific to treatment components, we will: (1) assess the number of sessions completed by participants in 
each group, (2) assess the percent of completed mindfulness home practice assignments among intervention 
participants as compared to the home assignments from the ES group, and (3) compare the retention rate of 
participants assigned to the MMMI group to that of participants assigned to the ES control condition. High 
retention and homework completion rates will indicate that participants found the intervention acceptable and 
that, similar to the MMCP program (Brintz et al., in press), six sessions are acceptable. Based on prior studies 
conducted we anticipate 81% of those who meet study criteria and agree to participate will attend 4 to 6 sessions 
and complete the post-training semi-structured interview or other survey measures. Forty (40%) of those who 
attend 4 to 6 sessions will complete 80% or more homework, ~40% who attend 4 to 6 sessions will complete 
40% to 80% of homework, and ~20% who attend 4 to 6 sessions will complete less than 40% of the homework. 
Acceptability will also be evaluated with the Client Satisfaction Questionnaire (≥80%) and via two questionnaires 
developed for this study: (1) whether individuals intend to continue using the skills learned in the future, and (2) 
appropriateness of the intervention to treat moral injury.