Mindful Action for Pain: An Integrated Approach to Improve Chronic Pain Function
Phase: NA
Conditions: Chronic Pain
Sponsor: VA Office of Research and Development

Study Protocol and Statistical Analysis Plan 
Mindful Action for Pain: An Integrated Approach to Improve Chronic Pain Function 
Document Date: 12/12/2023 
NCT03800654 

Human Protocol (Version 1.31)
General Information
*Please enter the full title of your study::
Mindful Action for Pain: An Integrated Approach to Improve Chronic Pain Function
 
 
*Please enter the Study Number you would like to use to reference the study:
MAP
* This field allows you to enter an abbreviated version of the Study Title to quickly identify this 
study.
 
 
Add departments
and Specify Research Location:
Is 
Primary? Department Name
VASDHS - VASDHS
 
Assign key study personnel(KSP) access to the study
*Please add a Principal Investigator for the study:
 
Herbert, Matthew S., PhD
 
3.1 If applicable, please select the Research Staff personnel
 
A) Additional Investigators
Afari, Niloofar, PhD 
 Co-Investigator
Backhaus, Autumn L., PhD 
 Co-Investigator
Lang, Ariel J., PhD 
 Co-Investigator
B) Research Support Staff
Fishbein, Joel N., PhD 
 Post-Doc
Golshan, Shahrokh, PhD 
 Biostatistician
Henneken, Andrea Naomi 
 Clinical Research Associate
Higdon, Alexandra O., PsyD 

 Clinical Research Associate
Manchanda, James 
 Clinical Research Associate
Martinez, Erica 
 Research Associate
Purpura, Suzanna R., BS 
 Clinical Research Associate
Salamat, Jennifer S. 
 Study Coordinator
Tynan, Mara E. 
 Research Associate
Vera, Rosi Fedra 
 Student
*Please add a Study Contact
 
Herbert, Matthew S., PhD 
Salamat, Jennifer S. 
The Study Contact(s) will receive all important system notifications along with the Principal 
Investigator. (e.g. The project contact(s) are typically either the Study Coordinator or the Principal 
Investigator themselves).
 
VASDHS IRB
Human Subjects Protocol
v20190121
Section 1 - Preliminaries
Principal Investigator:
Matthew S. Herbert, PhD
Protocol Title:
Mindful Action for Pain: An Integrated Approach to Improve Chronic Pain Function
IRB Protocol Number:
H180175
Protocol Nickname:
MAP
Form Template Version:
v20150115
Date Prepared:
12/12/2023
Please be advised that this protocol application form has changed as a result of the 2018 Common 
Rule.  There are new questions and sections, and you may be required to provide additional information to 
previous sections.
1a) Is this study considered human research?
Yes 
No 
I don't know 

1b) Please select:
This is an application for a NEW human subject research protocol 
This is a revision of an existing protocol 
Was this study initially approved prior to January 21, 2019?
 Yes  
 No
Were you instructed to convert to the 2018 Common Rule Requirements?
 Yes  
 No
 Section 2 - Research Subjects
 
2a) What is the total planned number of VA-consented subjects?
Include the total number of subjects who will prospectively agree to participate in the study (e.g., documented 
consent, oral consent, or other).
106
 
2b) What is the total number of VA subjects who WILL NOT be consented?
Include the total number of subjects that will be included without consent (e.g., chart review).  Note: Data about 
people are still considered “human subjects” by the IRB, so even if you do not intend to contact the patients 
whose charts you will review, you still should enter the number of charts as your “planned subjects."
0
 Section 2.1 Consented Subject Groups
2.1) For each of the subject categories listed below, indicate whether or not these subject groups will 
participate in the study: 
2.1a) Children under the age of 18
Note:   If neonates or children will be involved in this study, certification by the Medical Center Director will be 
required. Only minimal risk research may be performed with children.  Only non-invasive monitoring and/or 
prospective observational and retrospective record review studies that are minimal risk can be conducted in VA 
involving neonates.
  Yes  
  No
2.1b) Pregnant women
 Yes  
 No
2.1c) Individuals with cognitive/decisional impairment
  Yes  
  No
2.1d) Non-English-speaking individuals
  Yes  
  No
2.1e) Prisoners of War (explicitly targeting this group)
  Yes  
  No
2.1f) Non-Veterans (Note: Justification for inclusion of non-Veterans will be required)
  Yes  
  No
2.1g) Incarcerated individuals (Note: VA CRADO approval will be required)

  Yes  
  No
2.1h) VA employees - including VA paid, IPA, or WOC (Note: Union review and authorization may be 
required)
 Yes  
 No
2.1i) Students of the institution (e.g., resident trainees) or of the investigator
 Yes  
 No
2.1j) Patients with cancer (or high cancer risk) [explicitly targeting this group]
  Yes  
  No
 Section 3 - Study Features   (these items default to "No" for convenience)
  
3) This section consists of several Yes/No questions addressing protocol characteristics.     Click on Save and 
.
Continue
 Section 3.1 Protocol Basics
Select all that apply
3.1a) The research 
 the participant.
intends to change
 Yes  
 No
3.1b) 
 with living participants to collect data or specimens with no intent to change them.
Interactions
  Yes  
  No
3.1c) This is a study that 
 has any 
 
never
subject contact and does not collect subject identifiers
  Yes  
  No
3.1d) This is a 
study involving retrospective or prospective medical records.
chart review 
  Yes  
  No
3.1e) This is a 
study occurring in-part or in-full at other locations.
multi-site 
  Yes  
  No
3.1f) There is an 
 component to this research. 
international
International research includes sending or receiving 
human derived data or specimens (identifiable, limited data set, coded, or deidentified) to or from an 
international source.  International research does not include studies in which VA is only one of multiple 
participating sites where the overall study-wide PI is not a VA investigator.
  Yes  
  No
3.1g) This study includes 
 (not including VA-leased space or CBOC clinics) conducted 
off-station activity
under VASDHS IRB approval.  Note: this does not include research conducted by a collaborator at their home 
institution under their institutional approval.
  Yes  
  No
3.1h) VA subjects will 
 in part or in full 
 (not including VA-leased space or 
participate
at other locations
clinics) under VASDHS IRB approval. Note: if this study involves remote participation of subjects, please 
indicate "no" and describe their remote participation in section 9 of the application.  This question is intended 
to understand whether participants must physically go to a non-VA location to participate in this VA research 
study. 
  Yes  
  No

 Section 3.2 Specimen Use and Data Repository
Indicate whether or not each of the following applies to this protocol
3.2a) Involves specimens that are left over from pathological or diagnostic testing (
)
non-research specimens
  Yes  
  No
3.2b) Involves 
 purposes 
specimens collected for research
only
  Yes  
  No
3.2c) This study includes 
 (specimens are retained for use outside of the purposes of this 
specimen banking
protocol)
  Yes  
  No
3.2d) The study involves 
genotyping or other 
DNA 
genetic analysis
  Yes  
  No
3.2e) Biological
will be sent outside of the VA.
 specimens/material 
  Yes  
  No
3.2f) A 
 is maintained (data are retained after completion of the protocol for other uses, 
data repository
 see  before checking "yes")
IMPORTANT:
?
 Yes  
 No
3.2g)  
of the VA (identifiable, coded, limited data set, or deidentified)
Data will be shared outside 
  Yes  
  No
 Section 3.3 Treatment and Clinical Trials
Indicate whether or not each of the following applies to this protocol
3.3a) Includes a 
 component (a research treatment)
treatment
 Yes  
 No
3.3b) Study is a 
  
clinical trial. Note:  A clinical trial is a research study in which one or more human subjects 
are 
 (which may include placebo or other control) to 
prospectively assigned to one or more interventions
evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.
 Yes  
 No
3.3c) Has a data safety monitoring board (
or data safety monitoring committee.
DSMB) 
 Yes  
 No
3.3d) Has a 
 (but not a DSMB) (this is not the data security plan, it is a safety plan).
data safety monitoring plan
  Yes  
  No
 Section 3.4 Drugs and Devices
Indicate whether or not each of the following applies to this protocol
3.4a) 
 that require 
 action such as an Investigational New Drug (IND) approval or exemption or 510
Drugs
FDA
(k) approval.
  Yes  
  No

3.4b) Other drugs, supplement, etc. that
action for inclusion in the study.
 do not require FDA 
  Yes  
  No
3.4c) Medical 
 IDE approval or waiver
devices requiring FDA
  Yes  
  No
3.4d)
 medical 
 Other
devices
  Yes  
  No
 Section 3.5 Risk and Hazards
Indicate whether or not each of the following applies to this protocol
3.5a) Study places subjects at 
(do not include risks that are due to standard care)
greater than minimal risk 
  Yes  
  No
3.5b) Human subjects are exposed to 
 (do not include standard care).
radioisotopes
  Yes  
  No
3.5c) Subjects have other 
 (e.g., x-rays) (do not include standard clinical use).
radiation exposure
  Yes  
  No
3.5d) Target population has psychiatric diagnosis, behavioral complaint, or chronic pain.
 Yes  
 No
 Section 3.6 Clinical Facilities and Standard Care
Indicate whether or not each of the following applies to this protocol
3.6a) Study 
 (e.g., adds required tests run in the VA lab for study purposes; research 
uses VA clinical services
procedures concurrent with clinical care)
  Yes  
  No
3.6b) Includes procedures or drugs that will be considered part of standard care.
  Yes  
  No
3.6c) Involves 
purposes.
lab tests done for research 
  Yes  
  No
 Section 3.7 Subject Expenses and Compensation
Indicate whether or not each of the following applies to this protocol
3.7a) There may be expense or added 
or the subject's insurance.
costs to the subject 
  Yes  
  No
3.7b) This is a 
 and subjects may be billed for study drugs or procedures.
qualifying cancer treatment trial
  Yes  
  No
3.7c) This is a cancer treatment trial but 
 for study drugs or procedures.
subjects will not be billed

  Yes  
  No
3.7d) Subjects will be
(either in cash or other means such as a gift certificate).
 compensated 
 Yes  
 No
 Section 3.8 Subject Activities
Indicate whether or not each of the following applies to this protocol
3.8a) Involves 
 completed by subjects
surveys or questionnaires
 Yes  
 No
3.8b) Includes the use of 
 such as flyers, advertisements, or letters
recruitment materials
 Yes  
 No
3.8c) Involves facial 
 or audio or video 
of 
photographs
recordings 
patients
 Yes  
 No
 Section 3.9 Sponsors and Collaboration
Indicate whether or not each of the following applies to this protocol
3.9a) This research is a funded research project (commercial (industry) sponsor, NIH, VA, other).
  Yes  
  No
3.9b) Other 
is provided (e.g., drugs or supplies).
commercial (industry) non-financial support 
  Yes  
  No
3.9d) The protocol has 
 involvement (e.g., subjects or funding).
Department of Defense
  Yes  
  No
3.9c) The PI or other study staff member has a financial interest or other
related to 
 real or potential conflict 
this study.
  Yes  
  No
3.9e) This study involves 
research activities (research conducted at other institutions under the 
c llaborative 
o
authorities or approvals of the other institution/s). Note: this may include other VA and/or non-VA institutions, 
but does not include off-site VA research.
 Yes  
 No
 Section 4 - Estimated Duration
4) What is the estimated duration of the entire study?  (From IRB approval to IRB closure)
6 years
 Section 5 - Lay Language Summary
5) Provide a summary or synopsis of the proposed study using non-technical language (not more than 1 
paragraph)
The gold standard psychosocial intervention for chronic pain, Cognitive Behavior Therapy (CBT), 

is not universally effective and does not produce reliable increases in functional improvement. An 
emerging scientific model that holds promise for improving functional outcomes in chronic pain is 
the psychological flexibility (PF) model. Acceptance and Commitment Therapy (ACT) is the best 
known treatment from the PF model, but like CBT, ACT falls short on achieving meaningful 
changes in function for individuals with chronic pain. Nonetheless, there is empirical support that 
improvements in pain outcomes are mediated by PF treatment processes, giving support to this 
model and suggesting that identifying alternative ways of increasing PF may lead to significant 
increases in functional improvement. There is compelling empirical rationale that the 
mechanisms underlying formal mindfulness meditation, a practice used to train non-judgmental 
awareness and attention to present-moment experiences, will bolster PF processes and, in turn, 
facilitate functional improvement. To test this rationale, the PI has developed a novel 8-week 
group-based intervention, Mindful Action for Pain (MAP). MAP is distinct from ACT in that formal 
mindfulness meditation practice, which has never been tested within the PF model, is a principal 
treatment method, and it is integrated with experiential methods from different evidence-based 
treatment approaches (ACT, Dialectical Behavior Therapy) to address the key psychological 
barriers to optimal functioning. 
In phase 1, the initial MAP protocol will be executed with participants with chronic pain and 
iteratively refined based on participant feedback. 
In phase 2, we will complete a pilot randomized controlled trial comparing MAP to CBT that will 
allow us to estimate initial treatment effects and determine if a future, large-scale trial is 
warranted.
 Section 6 - Specific Aims
6) Provide a statement of specific aims and 
 that serve as the basis for this protocol.  Emphasize 
hypotheses
those aspects that justify the use of human subjects.
This proposal seeks to develop and initially evaluate an integrated, model-driven mindfulness-
based intervention for chronic pain, Mindful Action for Pain (MAP), designed to help Veterans with 
chronic pain achieve sustained functional changes driven by personal values. To accomplish this, 
we have chosen the psychological flexibility (PF) model. PF refers to the ability to behave 
consistently with one’s values even in the face of unwanted thoughts, feelings, and bodily 
sensations such as pain. The PF model is especially applicable to chronic pain because of its 
ultimate goal of supporting increased engagement in meaningful life activities. MAP is unique in 
that it integrates evidence-based treatment methods from Mindfulness-Based Stress Reduction 
(e.g., formal mindfulness meditation), Acceptance and Commitment Therapy (metaphors and 
experiential exercises), and Dialectical Behavior Therapy (e.g., informal mindfulness techniques) 
within a group-based delivery approach that is guided by the PF model. This application seeks to 
develop MAP (Phase 1) and conduct a pilot randomized trial of MAP vs. CBT for chronic pain (CBT-
CP) (Phase 2).
Aim 1: Fully develop MAP in a population of Veterans with chronic pain (Phase 1).
Aim 2: Evaluate the feasibility of a future randomized efficacy trial of MAP vs. CBT-CP (Phase 2).
Hypothesis 1: MAP and CBT-CP will be feasible to deliver, as evidenced by attainment of 
recruitment goals, retention rates > 80%, and high credibility and expectancy ratings.
Aim 3: Estimate the preliminary impact of MAP and CBT-CP to determine if a future efficacy trial 
is warranted. 
Aim 4: Explore the relationship between meditation adherence and treatment outcomes.
Aim 5: Explore objective measures of physical activity (actigraphy) at baseline and post-
intervention as a potential future index of functional outcomes.
 Section 7 - Background and Significance
7) Provide a succinct discussion of relevant background information to justify performing the proposed study.
According to the Veterans Health Administration, the goal of pain treatment is to improve physical 
and psychological functioning, emphasizing non-pharmacological approaches to target 
psychosocial factors that maintain disability (Department of Veterans Affairs, 2009). 

Unfortunately, the gold standard psychosocial intervention for chronic pain, Cognitive Behavior 
Therapy for chronic pain (CBT-CP), is not universally effective and does not produce reliable 
increases in functional improvement (Eccleston, Williams, & Morley, 2009). Veterans with chronic 
pain would greatly benefit from innovative, theoretically-grounded alternative interventions that 
accomplish the goals set forth by the VHA. An emerging scientific model that holds promise for 
improving functional outcomes in chronic pain is the psychological flexibility (PF) model.
 
The PF model consists of six interrelated processes that are targeted in treatment: present 
moment contact, acceptance, cognitive defusion, self-as-context, values, and committed action. 
Briefly, present moment contact refers to voluntary attention to the present as opposed to 
dwelling in the past or future. Acceptance is the willingness to openly experience unpleasant 
internal stimuli (thoughts, emotions, memories, etc.) when doing so is helpful for moving in a 
desired life direction. Cognitive defusion refers to the ability to see thoughts as a passing 
experience and to have experiences without being dominated by one’s appraisal of them. Self-as-
context, sometimes called self-as-observer, refers to a perspective of the self that remains stable 
as one’s circumstances change. Values are desired qualities of ongoing action that are rooted in 
the one’s personal sense of meaning and purpose. Committed action is the flexible and persistent 
approach towards chosen goals. These processes are often grouped into acceptance processes 
(present moment contact, acceptance, cognitive defusion, and self-as-context) and change 
processes (values, committed action) that work in concert to decrease maladaptive behaviors and 
increase adaptive behaviors, respectively. An impressive feature of the PF model is its trans-
diagnostic nature. Indeed, there is evidence that the PF model is applicable across a range of 
conditions beyond chronic pain, including depression, anxiety, psychosis, diabetes, epilepsy, 
smoking cessation, and stigmatizing attitudes.
 
Similar to CBT-CP, the best known treatment from the PF model, Acceptance and Commitment 
Therapy (ACT), falls short on achieving meaningful changes in function for individuals with chronic 
pain (Hughes et al., 2016). However, there is empirical support that improvements in pain 
outcomes are mediated by PF treatment processes, giving support to this model and suggesting 
that identifying alternative ways of increasing PF may lead to significant increases in functional 
improvement. The most compelling treatment method that has never been tested within the PF 
model is formal mindfulness meditation. Although ACT is considered a "mindfulness-based 
therapy," the ACT approach emphasizes "informal mindfulness" techniques, not formal 
mindfulness meditation (Hayes, Strosahl, & Wilson, 2012). Formal mindfulness meditation entails 
concentrating on one primary object (typically the breath) until attention is stable and then 
expanding awareness to include all physical and mental events with the intention of developing 
non-judgmental awareness of moment-to-moment experience (Kabat-Zinn, 1982). Unlike 
informal mindfulness techniques, which is difficult to precisely define, formal mindfulness 
meditaiton is a practice, and like any type of practice, demonstrates practice effects. For 
example, several studies show a dose-response relationship between formal mindfulness 
meditaiton practice and improvements in physical and mental health. Further, neuroimaging has 
provided strong evidence of biological changes associated with formal mindfulness meditation. In 
a 2016 meta-analysis, formal mindfulness meditation was consistently associated with increased 
activation in neural areas associated with interoception (insula), and with voluntary regulation of 
thought and action (left inferior frontal gyrus, supplementary motor area, premotor cortex) (Fox 
et al., 2016). Finally, and importantly, there is evidence that formal mindfulness meditation 
targets core PF treatment processes (Bieling et al., 2012; Carmody et al., 2009).
 
The proposed project aims to maximize functional improvement in Veterans with chronic pain, a 
goal that has largely remained elusive with existing treatment approaches. MAP seeks to 
accomplish this by using the PF model to guide the integration of formal mindfulness meditation 
practice and other evidence-based techniques to address key psychosocial barriers to optimal 
functioning. Being a trans-diagnostic concept, increasing PF holds promise to simultaneously 
decrease pain-related barriers to functional improvement as well as barriers related to common 
comorbidities (e.g., anxiety, depression, PTSD). By increasing engagement in valued life activities 
despite pain, Veterans may find greater quality of life and be able to achieve higher levels of 
functioning. This reduction in disability holds promise to reduce the healthcare and societal costs 
associated with chronic pain. 
 
 Section 9 - Design and Methods
9) Describe the research design and the procedures to be used to accomplish the specific aims of the 
project.  Provide a precise description of the planned data collection (include what systems or databases will 
be used/accessed to gather data), analysis and interpretation.  For chart review studies, include the timeframe 
of collection.  Address sample size, inclusion of women and minorities.  Define in clear terms exactly what will 
 
be done to the human subjects.

*****Please scroll down to see temporary measures to be implemented during COVID 
social distancing requirements*****
Approach
This proposed project consists of two phases across the 5-year award perioid: 1) 
development and refinement of MAP and 2) a pilot randomized trial to evaluate 
feasibility and estimate the preliminary impact of MAP vs CBT-CP.
Procedures: Phase 1, Protocol Refinement (years 1 - 2)
     Potential participants will be recruited primarily from the Behavioral Medicine and Primary 
Care clinics at the VASDHS (other recruitment strategies are discussed in 11 Recruitment). 
Participants recruited through Behavioral Medicine and Primary Care clinics will give permission to 
their provider for the study coordinator to contact them. The study coordinator will perform a 
telephone screening to discuss the study and initial eligibility. Participants that appear eligible and 
are interested in participating will be invited for an in-person visit to obtain informed consent and 
and complete the Mini International Neuropsychiatric Interview (see 
) to confirm 
Measures
eligibility. After consent is obtained, the participant will complete measures before, during and 
after the intervention.  Participants will receive a payment of $40 for the baseline assessment, 
$40 for the post-intervention assessment, and $40 for a 3-month follow-up assessment. The 3-
month follow-up assessment will occur either in person or by phone, whichever is most 
convenient for participants. Additionally, participants will receive $20 for the mid-treatment 
qualitative phone interview and $20 for a post-treatment qualitative phone interview (described 
below).
     The initial protocol for MAP is based on a transdiagnostic mindfulness group protocol 
developed by the PI and offered clinically at VASDHS 2016 - 2018, called Mindful Living (pain was 
not the focus). The initial refinement of the 8-week MAP protocol will be done to assure that the 
material is accessible to Veterans seeking treatment for chronic pain. Based on feedback from 
each MAP session and the two qualitative phone interviews, the PI will refine the approach with 
his study team to accomplish the aims of the intervention. The subsequent MAP group will be run 
incorporating potential improvements identified using the refinement strategies discussed below.
Number of Visits: Visit 1: Consent, MINI, baseline measures and actigraphy; Visits 2 - 4: MAP 
sessions 1 - 3; Visit 5: MAP session 4 and mid-treatment qualitative phone interview; Visit 6 - 9: 
MAP sessions 5 - 8; Visit 10: Posttreatment measures, actigraphy, posttreatment qualitative 
phone interview; Visit 11: 3-month follow-up measures (may be done by phone).
Subject Educational Materials: Educational materials will be printed for participants. Guided 
meditation CD recordings will be provided to participants, in-person or mailed, or accessed 
through the LifeData app. Based on participant feedback during Phase 1, we may alter the guided 
meditation instructions to best fit the needs of participants prior to Phase 2, in which guided 
meditation instructions will no longer be altered. Participants may also request a CD if they do not 
have easy access to a computer with internet capabilities.  
Participants: Participants in both phases will be Veterans with chronic pain who are able to 
consent and willing to participate (refer to Human Subjects for detailed inclusion/exclusion 
criteria). Co-occurring disorders such as depression, anxiety, and PTSD are permitted provided 
that chronic pain is the primary presenting complaint. 
Sample Size: Based on Dr. Lang’s (co-investigator) past experience in intervention development, 
it is estimated that 4 MAP groups of 5 participants per group will be needed to achieve Phase 1 
refinements with a total sample size of 20 Veterans.  
Refinement Strategies: Each MAP cycle will be refined based on qualitative and quantitative 
feedback from study participants. Participants will be informed of the goal of refining the 
intervention, and will be encouraged to provide honest feedback about their experience. Initially 
we will focus on the extent to which participants understand and believe in the approach, and 
challenges in establishing a daily meditation practice. Starting at the 2
 session, each participant 
nd
will complete a brief questionnaire after each session to assess their understanding of material 
and satisfaction with treatment delivery. Examples of questions participants would compete after 
each MAP session include: Did you understand today's topic? (Yes/No; If no, please briefly 
explain); Did you understand the exercises and examples used in today's group? (Yes/No; If no, 
please briefly explain); Were you satisfied with the way facilitator explained today's topic (Yes
/No; If no, please briefly explain); Is today's topic applicable to your life (Yes/No; If no, please 
briefly explain).

Further, at mid-treatment (between session 4 and 5) and post-intervention, Dr. Backhaus (co-
investigator and co-mentor on CDA award) will administer a 15-20 min phone interview with each 
Phase 1 participant. The purpose of these phone calls is to determine 1) overall satisfaction with 
and perceived benefit of MAP, 2) the performance of the facilitator (the PI) and any positive or 
negative feedback to explore the relationship between leader characteristics and treatment 
effects, 3) understanding and adherence to the formal meditation practice, and 4) the ability to 
relate mindfulness with PF processes. Phone calls will be audiotaped in order to collect and score 
qualitative data. The qualitative questions were developed with input from Dr. Backhaus (co-
mentor) and Dr. Hurst (qualitative methodology consultant) and can be found in the 27. 
 of this application. As themes are identified in the responses, subsequent 
Attachments
questioning may be refined to try to elicit types of feedback that will further develop our 
understanding of the participants’ experience and how to best achieve the goals of MAP.
The PI will meet regularly with the research team during Phase 1. In these meetings, we will 
discuss feedback from participants and what modifications are in order. In particular, the research 
team will be looking for any difficulty in understanding the concepts being presented (different 
approach? more or less time for discussion?), the perceived appropriateness of exercises
/metaphors (did participants relate personally? do they fit with military/veteran culture?), 
challenges in engaging in meditation practice (to what extent did participants engage in practice 
outside the session? any observable discomfort or lack of engagement in the class setting? Do our 
measures seem to be capturing actual behavior?). Based on that material, we will modify that 
session in the protocol and plan for the next class session (e.g., choosing to explain again 
material that was not well understood, to give an alternative metaphor to assist in understanding 
a concept, or to modify a practice). Adjustments made to the original protocol will be 
incorporated into the manual and reviewed by the research team for use in the next MAP group. 
Decisions about protocol changes will be made by consensus among the primary research team 
(the PI and co-investigators). We will allow 1 month between MAP cycles to review and make 
refinements to the protocol. This period of time will also be used to recruit for the next group.
Procedures: Phase 2, Feasibility of MAP vs CBT-CP
In Phase 2, we will conduct a pilot randomized trial consisting of 12 groups, randomly assigning 6 
groups to receive MAP or CBT for chronic pain (CBT-CP; see Description of CBT-CP below for 
rationale of comparison group). As in Phase 1, potential participants will be recruited primarily 
from the Behavioral Medicine and Primary Care clinics at the VASDHS, and other clinics as 
needed. Groups will be randomly assigned to MAP or CBT-CP in a 1:1 ratio based on a computer-
generated randomization table produced by Dr. Golshan (biostatistician consultant). The refined 
procedures from Phase 1 will be followed for securing consent, conducting assessments and 
providing compensation for participation, and the same eligibility criteria will apply. However, 
participants in Phase 2 will not complete weekly post-session questionnaires or mid-intervention
/post-intervention qualitative phone interviews.
Sample size for Phase 2: In Phase 2, we will conduct 12 groups (6 MAP and 6 CBT-CP) with 7 - 8 
Veterans in each group to examine the feasibility of a future RCT and preliminary response to 
MAP (year 3 = 4 groups; year 4 = 6 groups; year 5 = 2 groups). Anticipating up to a 20% 
attrition rate, 86 participants will be recruited for Phase 2. 
Number of Visits: Visit 1: Consent, MINI, baseline measures and actigraphy; Visits 2 - 9: MAP 
or CBT-CP sessions 1 - 8; Visit 10: Posttreatment measures, actigraphy; Visit 11: 3-month follow-
up measures (may be done by phone); Visit 12: 6-month follow-up interview using Microsoft 
Teams.
Interventions. An overview of the MAP intervention is described below, as well as the CBT-CP 
intervention. Both groups use an 8-week, 90-minute session protocol. The MAP intervention will 
be delivered solely by the PI. The PI is a licensed clinical psychologist with several years of 
experience conducting group and individual therapy for chronic pain using mindfulness-based 
techniques. For the CBT-CP intervention (Phase 2 only), we will use a manualized protocol 
developed at the VASDHS used in previous research (Wetherell et al., 2011). In the second half 
of Year 2 of the award, a part-time study therapist will be hired and trained to deliver the CBT-CP 
intervention. This therapist will be required to have graduate (at least master’s level) training in 
psychology, and will be recruited within the expansive VASDHS and UCSD communities. The 
study therapist will be supervised by Dr. Backhaus (co-investigator), who is a certified CBT-CP VA 
provider and the current supervisor for trainees in the Behavioral Medicine clinic that provide 
group-based CBT-CP at the VASDHS. Dr. Backhaus will train the study therapist and ensure 
competency prior to the start of Phase 2. The study therapist will have weekly check-ins with Dr. 
Backhaus via in-person or telephone while facilitating CBT-CP groups to ensure minimal drift from 
the protocol and to answer any questions that arise.     
Description of MAP

In MAP, participants are first exposed to mindfulness (paying attention in a particular way: on 
purpose, in the present moment, without judgement) and instructed how to engage in formal 
practice (session 1). Similar to other formal mindfulness meditation interventions, MAP consists 
primarily of two principal techniques: sitting meditation and body scan meditation. Briefly, sitting 
meditation consists of focusing attention on the sensations of breathing, noticing when the mind 
has wandered from the breath, briefly noting the source of wandering (e.g., “pain in shoulder,” 
“thinking,” etc.), and returning attention back to the sensation of breathing. The body scan 
meditation entails sustaining and moving attention around specific body parts starting at the toes 
and ending at the head (or vice versa). Similar to sitting meditation, when the practitioner notices 
the mind has wandered, the source of wandering may be briefly noted and attention is returned 
to the body. Starting after the 1  session, Veterans are expected to engage in daily formal 
st
mindfulness meditation, at first using provided audio recordings and later without recordings, and 
complete a daily meditation diary. Home meditation practice will follow a similar protocol as other 
meditation-based interventions at the VA. Specifically, Veterans will have access to audiotapes 
that vary in duration (5 - 20 minutes) via the Lifedata application or audio CD if preferred for the 
sitting and body scan meditations. Audio instructions are provided by Dr. Herbert and links to 
publicly available guided meditations. This will enable the most control over meditation instruction 
and allow alterations to instructions during Phase 1. Sample meditation scripts are provided in 27. 
.
Attachments
Topics for sessions 2 through 8 address PF processes (present moment contact, acceptance, 
cognitive defusion, self-as-context, committed action, and values) using experiential methods 
from ACT and DBT, scaffolded on the formal mindfulness meditation practice to support values-
based living. For example, in the “Tug-of-War” exercise, which targets the acceptance process, a 
Veteran from the group is asked to engage in a tug-of-war (using an actual rope) with the group 
facilitator. The Veteran is asked to imagine the facilitator represents his pain, and between them 
is a fiery pit. The Veteran and facilitator (i.e., pain) proceed to engage in a tug-of-war to try to 
win the tug-of-war. The take home message of the exercise is that when engaged in a tug-of-war 
with pain, one is bound to pain and unable to engage fully in other activities, and when one drops 
the rope (i.e., acceptance), there is increased ability to move freely, even though the facilitator (i.
e., pain) remains. This naturally leads to a group discussion of how acceptance of pain can help 
one move towards values-congruent goals despite pain. In MAP, Veterans will be subsequently 
asked what the relationship between mindfulness and the “Tug-of-War” exercise (e.g., having the 
ability to notice when a tug-of-war with pain is occurring in real time and how to proceed), being 
prompted as needed. DBT methods, primarily participate and one-mindfulness skills, are 
particularly helpful in this exercise to promote engagement in values-based action. The facilitator 
will then engage in a question and answer session with the group about the practical utility of 
formal mindfulness meditation (e.g., during formal mindfulness meditation, we practice “dropping 
the rope” with pain by noticing when it distracts from the practice and allowing it to be there (i.e., 
dropping the rope), and then choosing to return to the object of focus).This same process is 
repeated in each session to continuously reinforce the relationship between formal practice and 
PF processes. Because values, operationalized as desired qualities of ongoing action, serve as the 
context for behavior change within the PF model, values are introduced early to provide maximal 
time during MAP to help Veterans clarify values and values-based action, as well as the 
relationship between mindfulness and values-based action. This is accomplished through in-
session experiential exercises, discussions, and homework. Each MAP session is 90 minutes and 
begins with a formal mindfulness meditation practice (10-15 mins), a review of homework and 
previous topics (10 – 15 minutes) experiential exercises and discussions of a treatment topic (35-
45 minutes), and closes with an informal mindfulness exercise and formal mindfulness meditation 
sitting (10-15 minutes).
Description of CBT-CP
As aforementioned, the CBT-CP comparison group will use an 8-week, 90-minute session, 
manualized protocol developed at the VASDHS and used in previous research (Wetherell et al., 
2011). This protocol is based on the three-component CBT model (thoughts, feelings, behaviors) 
with the rationale that controlling some of the factors that contribute to pain can lead to a 
decreased subjective experience of pain. CBT-CP focuses on training participants to manage their 
pain using a variety of techniques, including pain monitoring, pacing, increasing pleasant 
activities, progressive muscle relaxation, thought challenging, and problem skills training. The net 
results of these strategies is to control pain by changing its physical, cognitive, behavioral, and 
emotional precursors, leading to reduced pain severity and resulting beneficial consequences on 
pain interference, quality of life, and physical activity. Similar to MAP, CBT-CP emphasizes the 
importance of at-home practice assignments to develop skills taught in session.
Treatment Fidelity 
Treatment fidelity is essential to the reliability and validity of study findings as well as the 
eventual large-scale trial and dissemination of MAP. We will employ several strategies 
recommended by the National Institutes of Health Behavior Change Consortium to develop a 

treatment fidelity checklist for MAP during the proposed project (Bellg et al., 2004). Treatment 
dose across both treatment groups will be equivalent. I will conduct all MAP sessions during both 
phases, and the part-time study therapist will administer all CBT-CP sessions in Phase 2. Using 
different therapists for the MAP and CBT-CP interventions will maximize treatment adherence and 
minimize contamination across groups. To ensure my competency, a portion of the time during 
weekly meetings with Dr. Afari (co-investigator and primary mentor on CDA) will be reserved to 
minimize drift from the MAP protocol.
In order to ensure that treatment is delivered consistently throughout Phase 2, all treatment 
sessions will be audiotaped. A random sample of 10% of all treatment sessions, divided equally 
across type of intervention, will be reviewed by Dr. Backhaus. For the CBT-CP groups, tapes will 
be coded for therapist competence as well as adherence to the CBT model using a similar rating 
system use for a previous CBT for chronic pain trial at the VASDHS (Wetherell et al., 2011). Dr. 
Backhaus also will evaluate MAP sessions based on the treatment fidelity checklist we develop to 
test for feasibility of fidelity tracking. Undertaking treatment fidelity evaluations in this manner 
will allow me to develop the necessary skills and documents necessary to ensure treatment 
fidelity in future trials.
Data and Data Analysis
Phase 1: Analyses for Aim 1 will be directed toward the development of MAP and collection of 
data to inform modification of the treatment. Qualitative and quantitative data will be collected 
and analyzed to achieve this. The purpose of the qualitative data is to synthesize the information 
and present it to the research team in order to make modifications to the approach. Drs. Hurst 
(qualitative methodologist consultant) and Backhaus have extensive experience with qualitative 
methods and will provide guidance for conducting these analyses. Qualitative data will be 
analyzed using atlas.ti, a qualitative data analysis software package frequently used by Dr. Hurst. 
Qualitative data analysis starts with coding, a process in which quotes are marked and labeled. 
The labeled quotes are then sorted and grouped, so that categories, then concepts, then themes 
can be developed. As is often standard practice for qualitative data analysis, analysis will be 
concurrent with data acquisition. Quantitative data (see 
) will be collected to test 
Questionnaires
for feasibility of assessments and to compare with qualitative data. We will first examine the data 
for missing values. Descriptive statistics will be used to summarize the outcomes and detect and 
analyze outlies, data errors, and data distribution.
Phase 2: Data from subject tracking logs will be used to determine the proportions of Veterans 
1) who agree to be contacted out of the number approached about the study (general interest in 
the study), 2) who consent out of the number contacted (willingness to participate in the trial), 3) 
who attend the initial group meeting out of the number consented (enrollment), 4) who attend 
each class and complete the intervention out of the number who began (retention), and 5) 
reasons given for discontinuation. The number of contacts based on various recruitment 
strategies also will be recorded. Additional feasibility data includes: rate of missing data between 
treatment groups and per time point; differences in retention rate between treatment groups; 
factors influencing retention rate and their impact on study outcomes; completion of study 
measures and homework; and participants’ satisfaction with study procedure and treatment 
delivery method. Further, age, gender, race/ethnicity, medications (including pain and other 
medications), and changes to medications/chronic pain treatments (TENS, injections, etc.), as 
well as pain etiologies (collected via chart review) will be explored within and between groups as 
they relate to study measures. This information will be helpful for assessing the feasibility of MAP 
and future hypothesis generation.    
Additionally, we will examine the preliminary impact of MAP on pain interference (primary 
outcome), as well as pain acceptance, trait mindfulness, and pain catastrophizing (secondary 
outcomes). Other questionnaires that will be measured are listed in the 
 section. 
Questionnaires
Changes on these measures as well as participant satisfaction would also serve as indicators that 
MAP may be worthy of a future large-scale RCT. 
Initially, chi-squares and Analysis of Variance will be used to assess the effectiveness of the 
randomization procedures by comparing participants in each treatment condition on baseline 
variables. Within-group change will be assessed separately in MAP and CBT-CP groups on the 
primary (pain interference) and secondary clinical outcomes (pain acceptance, trait mindfulness, 
pain catastrophizing). We will plot means and standard deviations overtime to examine them 
visually, and determine the percentage of participants in each group that achieve minimally 
clinically important change on the BPI Pain Interference scale (1-point change, etc.). Additionally, 
we will use linear mixed-effects (LME) models to explore preliminary estimates of treatment 
effects. Time will be added as fixed effects in models, and the intercept will be added as a random 
effect. Effect size for within-group change will be calculated according to procedures described by 
Cohen, and interpreted with caution and in the context of the 95% confidence interval that 
surrounds it. The preliminary within-group treatment effects of MAP will help determine our future 
directions. For example, medium-large treatment effects would provide signal for future testing 

 
Year 1
Year 2
Year 3
Year 4
Year 5
Phase 1
 
Hire research coordinator
x
 
 
 
 
 
 
 
 
 
Recruit, conduct groups, modify protocol
 
x
x
x
 
 
 
 
 
 
Data management and analysis
 
 
x
x
 
 
 
 
 
 
Finish MAP refinement
 
 
 
x
 
 
 
 
 
 
Phase 2
 
 
 
 
 
 
 
 
 
 
whereas small treatment effects would suggest a need for additional development. Within the 
CBT-CP group, treatment effects will be examined in relation to findings from other published pain 
trials with similar Veteran populations to ensure adequacy of CBT-CP delivery.   
We will also conduct preliminary between-group comparisons on the BPI Pain Interference 
measure to better understand if continuing to pursue evaluation of MAP is warranted. Given that 
functional improvement is the ultimate goal of this research, we chose pain interference as the 
key outcome for the preliminary between-group analyses and power calculations because it is a 
proxy for functional improvement and one the most commonly used outcome measure in 
psychosocial intervention trials of chronic pain. Group comparisons will be examined via LME with 
group (MAP vs. CBT-CP), time (10-total time points: baseline [1 time point], weekly during 
sessions [8 time points], post-intervention [1 time point]), and the treatment by time interaction 
added as fixed effects. The intercept will be added as a random effect. Effect size for the 
difference between groups will be calculated according to procedures described by Cohen. Effect 
size will be interpreted with caution, and in the context of the 95% confidence intervals that 
surrounds it.
Average time spent per week in meditation practice will be calculated from the LifeData mobile 
application or daily weekly diaries. The relationship between meditation practice time and study 
measures will be explored by adding the adherence rate to LME models as a covariate.
The actigraphy outcome will be the total activity count from each active interval, averaged across 
each 7-day observation period, excluding periods of missing data that occur due to temporary 
removal of the device. We will exclude participants that wear the Actiwatch < 5 valid days, with 
valid days defined as periods with < 4 hours of missing data.  Participants will be instructed to 
press the event marker button on the Actiwatch to denote the times they get into and out of bed. 
Rest intervals (analogous to time in bed) will be scored manually using event markers, activity, 
and light, following the methodology of Patel et al. (2015) , which takes into account that 
participants sometimes forget to press the event marker. Actigraphy data will be explored visually 
and via LME for trends of increased activity levels from baseline to post-intervention within group 
(Phase 1 and 2) and between groups (Phase 2) with guidance from Dr. Golshan (statistical 
consultant), who has previous experience analyzing actigraphy data.  
Data collection and quality control. Data management and statistical analysis will be 
supervised by the study statistician, Dr. Shahrokh Golshan. Dr. Golshan will oversee the 
development of the study database, which will be maintained on the secure VA research server. 
Participant names will be held separate from data. Subjects will be assigned a unique ID number, 
and the single name-to-ID relational file will be kept in an encrypted form electronically and in a 
locked filing cabinet physically. Data for this study will be entered into Excel. Statistical analysis 
will be conducted using SPSS, R and SAS software packages. Prior to inferential analyses, data 
will be examined for missing values and statistical outliers. All statistical transfer routines are 
inherently secure via their operating platform and they contain no patient names or personal data.
The assessment and questionnaires to be used are described in Secion 9.8
Timeline and feasibility.
The major study activities are outline in the table below.

Hire research assistant and study therapist
x
Pilot study: Recruit, conduct groups, collect 
data
 
 
 
 
x
x
x
x
x
 
Data management and analysis
 
 
 
 
x
x
x
x
x
x
Manuscript preparation 
 
 
 
 
 
 
 
x
x
x
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
NOTE: Due to COVID-19 concerns, session 7 and 8 (slated to occur on 3/17/2020 and 3/24
/2020) of cohort 3 may be conducted via the secure VANTS (VA National Teleconferencing 
System) line. Participants will be asked to give verbal consent and will be asked to be in a secure 
location during the teleconference to minimize breach of confidentiality.
UPDATED measures due to COIVD-19 social distancing requirements (5/18/2020)
The following are temporary procedures to allow for participation in this research protocol while 
maintaining social distancing due to the COVID-19 pandemic.
The protocol remains as approved with the following exceptions:
Consenting
If a Veteran is potentially interested in participation after initial contact, we will send an encrypted 
email (using VA Azure RMS) containing (1) the approved ICF, (2) the approved HIPAA document, 
(3) the CA Experimental Subjects Bill of Rights and arrange a telehealth meeting (using VA 
approved secure Telehealth communications software such as Veteran Video Connect, VA-
approved Cisco Webex, etc.) to complete the informed consent process, explain the HIPAA 
Authorization and CA Experimental Subjects Bill of Rights. The staff member will witness the 
signing of the ICF and HIPAA Authorization and will instruct the potential participant to provide 
documentation of written informed consent by either returning images of the documents through 
MyHealtheVet or by allowing a screenshot of the signed documents (approval date and signature 
must be clearly visible). These electronic documents will be stored electronically separate from 
study data on the Investigator’s R-drive, and the participant will retain their copies. Participants 
may also fax (secure landline) the consent and HIPAA documents which will be stored per the 
usual protocol after obtaining hardcopy consents.

Eligibility Assessment
Initial eligibility will continue to be determined through the pre-approved HIPAA-waived screening 
form during initial contact. Once documentation of written consent is received, research staff will 
conduct the  MINI (mental health assessment) administered by a study clinician to further 
determine eligibility. This will be conducted by telephone appointment or through a telehealth 
meeting, again using one of the approved systems above (Veteran Video Connect, VA-approved 
Cisco Webex, etc.)
Research Assessment/Data Collection
Once eligibility has been confirmed, the participant will complete study research assessments 
including data collection via questionnaires. These questionnaires will be administered and 
collected by the following methods: (1) Study participants are sent a link to a Qualtrics survey by 
study staff and can complete their survey on any internet-connected device with an internet 
browser, (2) through telephone where research staff will contact participants to collect responses 
to questionnaires, or (3) by sending an encrypted email (using VA Azure RMS) containing a 
password-protected fillable pdf of the questionnaires that the participant will return by one of 
three methods: (1)via encrypted email to a staff VA email account, (2) by fax (secure landline), 
or (3) via MyHealtheVet.
Group Treatment
Participants will engage in group treatment with the research study clinician via an arranged 
telehealth meeting (using Veteran Video Connect). Should technical difficulties arise using this 
method, teleconferencing (non-video) will be available through the VA Nationwide 
Teleconferencing system (VANTS line). Participants will be reminded of limits of confidentiality 
during these sessions.
 
 Section 9.5 Data Banking
   
9.5) Provide details about the data repository for example,
Identify what information will be retained.
Whether participation in the repository will be optional or required.
Whether or not identifiers are included with the banked data, Note:  If banking is optional and 
identifiable information will be retained, then the combined consent/HIPAA form may not be used.  Please 
use the single consent and HIPAA form 10-0493.
 Provide future use examples. 
Indicate how the study will comply with VHA Handbook 1200.12.
All data obtained as part of this study including, but not limited to, sociodemographic 
information, medical history, and psychosocial functioning, will be retained for future use in 
analysis not yet determined. Identifiers will be retained and this is stated in the consent form. 
The data repository will be established after closure of the protocol outlined in this application. 
The establishment and management of the data repository will comply with VHA Handbook 
1200.12.A repository SOP will be submitted prior to creation of the repository.
 Section 9.8 Questionnaires & Surveys
9.8) Provide the name and a reference for questionnaires/surveys that are standard or identify them here and 
attach a copy of the questionnaire/survey.  Questionnaires or surveys that are not clinical standard references 
must be uploaded.  Reference the help link for additional information related to surveys administered to VA 
 
personnel and approved platforms for web-based surveys.
See also attachment for tables of assessments by visit.
Eligibility: 
- The PEG (Krebs et al., 2009) is a brief pain screening instrument developed from the Brief Pain 
Inventory (described below). The PEG contains one item that assesses pain intensity (P), and 
two items that assesses pain interference: interference with enjoyment of life (E), and 
interference with general activity (G). In order to be eligible for the study (both phases), 

participants must score >4/10 on both pain intensity and one or both of the pain interference 
items.
- Mini International Neuropsychiatric Interview (MINI; Lecrubier et al., 1997): 15 - 30 minute 
interview used to identify the exclusionary conditions of current psychosis, mania, substance 
abuse within the past year, and suicidality. It also will be used to determine current and lifetime 
major depression, generalized anxiety disorder, and PTSD for descriptive purposes. The MINI will 
be administered only at the baseline assessment by the PI. 
Phase 1 Only:
-Reactions to class material and practices (logic, understandability, applicability, and self-efficacy)
All Phases:
- Demographics: age, gender, race/ethnicity, relationship status, years of education, SES/income
/living situation, occupation/work status, branch of service/highest rank
- Credibility/Expectancy Questionnaire (CEQ; Borkovec & Nau, 1972), given at end of 1st session 
to assesses how logical the treatment seems to the participant and how much they expect to 
benefit from it
- Client Satisfaction Questionnaire (CSQ-8; Larsen et al., 1997) 8-items
- Practice diary to determine average time spent per week in meditation practice (MAP group 
only). Participants will have option of using LifeData app to record daily meditation).
- Brief Pain Inventory (BPI; Cleeland & Ryan, 1994). The BPI consists of two subscales: pain 
severity (4-items) and pain interference (7-items). This questionnaire will be administered at the 
baseline assessment, weekly during the intervention (using the Polls function on WebEx), and at 
the post-intervention assessment. The Polls function on WebEx allows for participants to 
complete the BPI at the beginning of the session. Participants cannot see the responses of 
others. The Polls are saved on the PI's R drive located behind the VA firewall. 
- Chronic Pain Acceptance Questionnaire (CPAQ; McCracken, Vowles, & Eccleston, 2004). 20-
items
- Pain Catastrophizing Scale (PCS; Sullivan Bishop, & Pivik, 1995). 13-items
- Medical Outcomes Study 12-Item Short Form Health Survey (SF-12; Ware, Kosinski, & Meller, 
1996). 12-items
- Patient Health Questionnaire (PHQ-9; Spitzer, Kroenke, & Williams, 1999). 9-items
- PTSD Checklist for DSM-5 (PCL-5; Bovin et al., 2016). 20-items
- Mindful Attention and Awareness Scale (MAAS; Brown & Ryan, 2003). 15-items
- Adverse Childhood Experience Questionnaire (ACE; Centers for Disease Control and Prevention, 
2008). 10-items
- Injustice Experience Questionnaire (IEQ; Sullivan et al., 2008). 12-items
- Cognitive Fusion Questionnaire (CFQ; Gillanders et al., 2014). 7-items
- Insomnia Severity Index (ISI; Morin, 1993). 7-items
- Chronic Pain Values Questionnaire (CPVQ; McCraken & Yang, 2006). 12-items
- Medication will be recorded at the baseline (Visit 2) and post-intervention assessments (Visit 
11). Participants will be asked to have all medication bottles, including over-the-counter 
medications and dietary supplements, available at their assessment appointments.
- Medication/treatment changes and adverse events will be assessed weekly. Participants will be 
asked if they made any medication/treatment changes over the last week and if any adverse 
events occurred.
- Actigraphy. The Actiwatch Spectrum PRO (Phillips Respironics, Bend, Oregon) will be used as 
an objective measure of physical activity. The Actiwatch Spectrum PRO will be worn continuously 
on the non-dominant wrist for two one-week periods at baseline and post-intervention in both 
phases by all participants.
-6-month interview questions:
Example questions: 
1. What has been the most helpful part of the group for your pain?
2. When engaging in day-to-day activities, how are you able to manage pain?
3. What influence has the intervention had on your amount of physical activity?
4. What strategies did you learn from the group that you are currently using?
5. How has your relationship with pain changed since being in the group?
 Section 9.9 Data Safety Monitoring Board or Plan
9.9) Provide a Data Safety Monitoring Plan (DSMP) or the details of a Data Safety Monitoring Board; if a 
written plan is available, attach a copy of the plan to the submission form.
The Data Safety and Monitoring Board (DSMB) is comprised of Drs. Arpi Minassian, Fadel Zeidan, 
and Michael Thomas. Drs. Minassian, Zeidan, and Thomas are not associated with this research 
project and work independently of the PI, so they are able to monitor the trial independently. 

They are qualified to review the patient safety data generated by this study because of their 
unique experience in chronic pain management (Dr. Minassian), mindfulness-based interventions 
(Dr. Zeidan), and biostatistics (Dr. Thomas).
Drs. Herbert and Golshan will report to the DSMB on an annual basis.
 Section 9.11 Pictures and Audio/Video Recordings of Patients
9.11) Describe the purpose of photographs (facial), or audio, or video recordings of patients.  Describe 
whether the recordings will contain, or potentially contain, identifiers.  Note: use of photographs or recordings 
must be covered in the informed consent process and documented consent documents (e.g., consent form, 
information sheets, telephone screen scripts).
In Phase 1, the phone calls that occur at mid-treatment and post-treatment will be audio-
recorded for qualitative data analysis purposes. Dr. Backhaus and the PI will be in charge of 
these analyses under the supervision of Dr. Hurst. Dr. Backhaus will complete the phone calls in 
her private office , and will record the conversation via a Sony ICDPX312 Digital Voice recorder 
by using the speaker-phone option. The Sony ICDPX312 Digital Voice recorder is compliant with 
VHA regulations, and often used as VASDHS for research and clinical purposes.
In Phase 2, audio-recordings will be made for all sessions in both treatment groups (MAP and 
CBT-CP) using the Sony ICDPX312 Digital Voice recorder. Audio-recordings of the MAP group will 
be used for quality control and to develop an adherence tracking form for future research, 
whereas Dr. Backhaus will review randomly selected recordings of the CBT-CP sessions to assure 
adherence to the protocol. 
Recordings from both Phase 1 and 2 will be uploaded and imported from the Sony ICDPX312 
Digital Voice recorder via USB to the VA secured server system that is backed by the VA firewall. 
The audio recordings will be saved as MPG files and stored on the VA secured network R drive. 
The audio recordings will be labeled with a unique ID number, and the code key kept in a 
separate locked cabinet. Once the audio-recordings are uploaded and saved on the VA secured 
server, they will be deleted from the Sony ICDPX312 Digital Voice recorder.
Recordings from Phase 2, 6-month interviews:
We will use Microsoft Teams to record this interview session. Per Research Guidance Article 
KB0116766, VA investigators may use VA MS Teams to conduct remote VA research subject 
interviews. VA investigators are allowed to record those interviews using VA MS Teams if all 
applicable human subject protection regulations and policies as well as all applicable privacy 
laws, regulations and policies are met. We also may use the Pocket Memo Voice Recorder 
DPM8000 to record these interviews, which allows for audio-only recording. The Pocket Memo 
Voice Recorder DPM8000 has been previously approved through VA IRB.
When possible, participants will not be addressed by name during interviews, and transcribed 
interviews used for data analysis will deidentify participants.
 Section 10 - Human Subjects
10) Describe the characteristics of the proposed subject population. Include age, gender, ethnicity, and health 
status as appropriate.  Note: Data about people are still considered “human subjects” by the IRB, so even if you 
do not intend to contact the patients whose charts you will review, you still describe the characteristics related to 
   
the subjects whose charts you will review.
Provide inclusion and exclusion criteria as appropriate.  Provide a statement how non pregnancy is 
confirmed if pregnancy is an exclusion criteria.
For multisite studies, provide the total number of subjects from all sites and include description of the 
local site's role as a coordinating center if applicable.
Indicate the number of VA participants to be studied.
Indicate the estimated number of 
 subjects that will fail the screening process, if any.
consented
The study will involve ~106 Veterans in the San Diego area. We expect the demographic make-
up to approximate that of the VASDHS. Inclusion criteria are: 1) diagnosis of a chronic, non-
terminal pain condition, 2) pain most days (>3 days/week) for at least 6 months, and 3) average 
pain severity and interference with enjoyment of life and/or general activity >4/10 over the past 

1.  
2.  
3.  
4.  
5.  
6.  
7.  
week, as measured by the PEG (described in 9.8 Questionnaires). The following are exclusion 
criteria: 1) serious or unstable medical or psychiatric illness (e.g., unmanaged psychosis, manic 
episode, or substance abuse within the past year) or psychosocial instability (e.g., 
homelessness) that could compromise study participation, 2) active suicidal ideation or history of 
suicide attempt within the past year, 3) current participation in group psychotherapy for pain or 
any type of individual psychotherapy, or 4) changes to professionally delivered pain or mood 
treatments (e.g., no discontinuation of a treatment; no increasing the dose of medication) one 
month preceding the baseline assessment.
 Section 10.2 Pregnant Women
10.2a) Are pregnant women the focus of the research?
 Yes  
 No
10.2b) Provide the justification for including pregnant women and address any special risks, protections, and 
safeguards.
Pregnant women will not be excluded from the study as there is no known risk to the woman or 
fetus associated with the methods used in either intervention. No additional protections are 
needed.
10.2c) It is indicated that pregnant women are the focus of the research.  All of the below must be certified to 
be true to permit enrollment of pregnant women.
Where scientifically appropriate, preclinical studies including studies on pregnant animals and clinical 
studies including studies on non-pregnant women, have been conducted and provide data for assessing 
potential risks to pregnant women and fetuses.  A description of such studies should be included in the 
project application.
The risk to the fetus is caused solely by interventions or procedures that hold out the prospect of direct 
benefit for the woman or the fetus; or, if there is no such prospect of benefit, the risk to the fetus is not 
greater than minimal and the purpose of the research is the development of important medical 
knowledge which cannot be obtained by any other means.
If the research holds out the prospect of direct benefit to the pregnant woman, the prospect of a direct 
benefit both to the pregnant woman and the fetus, or no prospect of benefit for the woman nor the fetus 
when the risk to the fetus is not greater than minimal and the purpose of the research is the development 
of important biomedical knowledge that cannot be obtained by any other means, the pregnant woman’s 
informed consent is obtained in accordance with the informed consent provisions of 38 CFR 16.116, 
paragraphs 30-35 and 45 CFR 46.204(d).
Each individual providing informed consent is fully informed regarding the reasonably foreseeable 
impact of the research on the fetus.
Any risk is the least possible for achieving the objectives of the research.
There are no inducements included in the research, monetary or otherwise, that will be offered to 
terminate a pregnancy.
Individuals involved in the research will have no part in any decisions as to the timing, method, or 
procedures used to terminate a pregnancy.
 Agree
 Disagree
 Section 10.6 Avoiding coercion of students or employees
10.6) Indicate how coercion of students and/or employees will be avoided:

Employees or students of the study staff will not be recruited. Otherwise, student status or 
employment with the VASDHS does not preclude participation.
 Section 11 - Recruitment
11) Describe, step-by-step, the plans for recruitment of subjects (or selection of subjects as in record review). 
This description must include how, when, and where potential subjects are approached as well as procedures 
for identifying potential participants (through medical records, physician referral, third-party 
sources, etc.).  Include how selection is equitable.  Indicate if vulnerability to coercion may be present and if so 
plans to ensure voluntary participation.
Recruitment strategies will be the same for Phase 1 and Phase 2.
Eligible participants will contact our study in response to:
1) Referral from VASDHS clinics, including the Behavioral Medicine and Primary Care clinics
2) Flyers posted in San Diego VA hospital, including Mission Valley, Chula Vista, and Oceanside 
CBOCS, and
3) Research databases of Veterans who have previously consented to be contact about additional 
study opportunities.
4) Self-referral from the VA Research Website
5) Referrals from VHASDC PATH (Patient Assessment and Triage Hub)
Recruitment from VASDHS clinics: Potential participants will be recruited primarily from the 
Behavioral Medicine and Primary Care clinics at the VASDHS. Dr. Backhaus is the Clinic 
Coordinator at these clinics and receives approximately 20 – 25 referrals per month for chronic 
pain management. Thus, recruitment needs for the proposed study should be met by these two 
clinics. If need be, we may also recruit from the VASDHS Pain Clinic/ Anesthesiology, Physical 
Medicine and Rehabilitation, Urgent Care Center, and Spinal Cord Injury Unit. We will attend 
team meetings and network with clinicians to encourage referrals by clinicians in those sites. 
Veterans that are interested in the study will complete the Research Candidate Form and given a 
flyer about the study, with the study coordinator’s information (see Attachments). For these 
participants, we will request a partial waiver of consent/HIPAA for screening purposes (phone 
screening). The nature of the study will be explained, portions repeated as necessary, and 
questions answered. If participants appear eligible, they will be scheduled for an in-person 
screening session, where informed consent and HIPAA will be completed.
Recruitment from flyers: For potential participants that call in from the flyers, we will request a 
partial waiver of consent/HIPAA for screening purposes (phone screening).The nature of the 
study will be explained, portions repeated as necessary, and questions answered. If participants 
appear eligible, they will be scheduled for an in-person screening session, where informed 
consent and HIPAA will be completed. 
Recruitment from research databases: Veterans who have previously participated in research 
studies at VASDHS with investigators/co-investigators affiliated with the current study (e.g., Dr. 
Niloofar Afari’s “Technology Solution to Improve OEF/OIF Intake and Assessment Porgram”) that 
have agreed to be re-contacted about other research will be contacted by letter and/or phone 
after CPRS record screen if no immediate exclusion criteria is found. If the participant did not 
agree to initial contact by phone, a letter will be sent first (see Attachments). After a period of 2 
weeks, if no contact is made by the participant, study staff will follow up by phone and request 
verbal permission to administer the phone screen. 
Recruitment from VA Research Website: For potential participants that call in from the flyers, we 
will request a partial waiver of consent/HIPAA for screening purposes (phone screening).The 
nature of the study will be explained, portions repeated as necessary, and questions answered.
Recruitment from PATH: Study details will also appear on a current research list posted to the 
VHASDC Clinical Research Teams channel. Providers from the Patient Assessment & Triage Hub 
(PATH) can access this spread sheet and refer veterans directly to study during treatment 
planning.
 Section 11.1 Recruitment Materials
11.1) Identify all recruitment materials (flyers, advertisements, letters, etc.) that will be used; include the web 
address for any web-based advertisements. The text of all communications with prospective participants must 
be reviewed and approved by the IRB before it can be used.  You will be reminded to attach copies of 

recruitment materials to the initial submission packet.  Note:  Posting of flyers with pull tabs is not permitted 
within VASDHS (including the VMRF building).  However, you may request to advertise on the e-boards (located 
 
at the elevators and throughout the facility) or on the VASDHS Research Opportunities web-page.
For potential participants that call in from the flyers, we will request a partial waiver of consent
/HIPAA for screening purposes (phone screening). The nature of the study will be explained, 
portions repeated as necessary, and questions answered. If participants appear eligible, they will 
be scheduled for an in-person screening session, where informed consent and HIPAA will be 
completed. 
Additionally, we will provide Research Candidate Forms and flyers to clinicians in order to share 
and information about the research study, and acquire consent to be contact by phone.
See attachments for copy of Research Candidate From and flyer.
 Section 12 - Informed Consent
12) Indicate whether or not each category of consent is involved in this study:
12a) Will the study team obtain information or biospecimens for the purpose of screening, recruiting, or 
determining the eligibility of prospective subjects without (or prior to) obtaining informed consent of the 
prospective subject or the prospective subject’s LAR?
  Yes  
  No
12b) 
 informed consent
Signed
 Yes  
 No
12c) Waiver of documented consent (e.g., 
consent) for all or part of the study.
oral 
  Yes  
  No
12d) Request for a 
 of consent for all or some study activities.
waiver
  Yes  
  No
12e) Alteration of 
 of consent.
other required elements
 Yes  
 No
12f) 
assent to participate (Director approval will be required)
Child 
  Yes  
  No
12g) Will any language 
 be used by those obtaining consent and understood by the 
other than English
prospective participant or the legally authorized representative?
  Yes  
  No
12h) 
 to determine if participants have the capacity to consent for themselves.
Decisional Capacity Assessment
  Yes  
  No
12i) 
 consent (legally authorized representative)
Surrogate
  Yes  
  No
 Section 12.1 Informed Consent Process
12.1a) Will consent be obtained before any study procedures are performed (including screening procedures 
 
except screening procedures with Consent and/or HIPAA waiver when required)?
 Yes  
 No

12.1b) Will the information being communicated to the participant or legally authorized representative 
during the consent process include exculpatory language through which the participant or legally authorized 
representative is made to waive or appear to waive any of the participant’s legal rights or release or appear to 
release the Researcher, Sponsor, the VA or its agents from liability for negligence.
  Yes  
  No
12.1c) A master list of all VA subjects consented (written or not) under this protocol will be maintained.
 Agree
 Disagree
12.1d) Identify the circumstances under which consent will be obtained including where the process will take 
place; any waiting period between describing the research and obtaining consent including sufficient time for 
the prospective participant to consider participation, and any steps taken to minimize the possibility of 
coercion or undue influence.
Signed consent documents for VA subjects will use VA form 10-1086. Consenting will take place 
at the La Jolla clinic with a trained assessor/study coordinator in a private room and the 
participant will be given ample time to read the consent form and ask questions. At the first visit, 
prior to initiation of any study-related procedures, subjects will give their written consent to 
participate in the study after having been informed about the nature and purpose of the study, 
participation/ termination conditions, risks, and potential benefits. Informed consent is a process 
that is initiated prior to the individual’s agreeing to participate in the study and continuing 
throughout the individual’s study participation. Upon reviewing the document, the assessor will 
explain the research study to the participant and answer any questions that may arise. Extensive 
discussion of risks and possible benefits of this therapy will be provided to the participants as 
needed. The investigator will explain study procedures and let the participant know how many 
assessments he/she will be asked to complete. The participants will sign the informed consent 
document prior to any procedures being done specifically for the study. The participants may 
withdraw consent at any time throughout the course of the trial. A copy of the informed consent 
document will be given to the participants for their records. The rights and welfare of the 
participants will be protected by emphasizing to them that the quality of their medical care will 
not be adversely affected if they decline to participate in this study.
During COVID-19 pandemic restrictions for in-person research visits, participants may be 
remotely consented using approved Docusign as follows:
1) At the time of remote consenting, the study team member/consenter will send a DocuSign 
envelope (email containing links to the study documents) to the potential subject. The email will 
contain a reminder for the recipient to not sign the documents prior to the scheduled contact 
time. 
2) At the scheduled time, the study team member (referred to as “consenter”) will contact the 
potential subject via phone or using the approved video (VVC or Webex). The consenter will 
guide the potential subject to open the DocuSign envelope (email) and the linked study 
documents therein. The consenter will open a copy of the study documents on their own 
computer as a reference. The consenter will review the study documents with the potential 
subject, ask questions to gauge comprehension, and answer any questions and concerns. If the 
potential subject agrees to participate in the study, the consenter will guide them to fill in the 
fields in the study documents (e.g., “Last, First, Middle Initial” name field, Last 4 SSN field, etc.) 
and to sign the documents. When the subject has signed the documents, they will click “FINISH” 
to finalize the documents. 
3) While still on the phone or video with the subject, the consenter will receive an email 
notification to log into DocuSign. The consenter will verify that all fields are completed accurately 
and, subsequently sign the document(s) (e.g., ICF). The consenter will guide the subject on how 
to download a copy of the signed document(s) to the subject’s personal computer for their 
record. 
4) The consenter will download a copy of the signed document(s) to a study folder in the PI’s VA 
secure Research drive for study records. 
5) The consenter will document the consenting process as a “Research/Informed Consent” note 
in the subject’s medical record (in CPRS). The note will specify that consent was obtained over 
phone/video and DocuSign on the specific date.
 Section 12.5 Alteration of Other Required Elements of Consent

12.5) Identify the alteration to the required elements of informed consent and the justification for this 
approach.
The only aspect of informed consent that will be altered will be replacing discussion of the mPRO 
application to with LifeData application.
 Section 12.9 HIPAA Authorization
For each category below, indicate whether or not this study involves the indicated process:
12.9a) 
 HIPAA Authorization.  
Signed
**New Template is available in the ?  Help section**
 Yes  
 No
12.9b) HIPAA waiver to cover the entire study
  Yes  
  No
12.9c) HIPAA waiver for recruitment, screening, and/or for a portion of the study.
 Yes  
 No
12.9d) HIPAA Authorization or waiver is 
 for some or all of the study subjects (e.g. no health data).
not required
  Yes  
  No
 Section 12.10 HIPAA Waivers and Alterations
12.10a) Describe the purpose/nature of the HIPAA waiver or alteration and list specifically, what identifiers 
and health information are being requested under the waiver/alteration and identify whether the waiver is 
for access, use, and/or collection of this information.
The HIPAA waiver will be needed to screen for inclusion and exclusion criteria before in-person 
contact. This will include identifiers (name, SSN) and health information (diagnoses). This is used 
only to assess the information.
12.10b) The proposed access, use, and/or disclosure of PHI involves no more than a minimal risk to the 
privacy of individuals.
 Agree
 Disagree
12.10c) The plan to protect the identifiers from improper use and disclosure is adequate.
 Agree
 Disagree
Describe the plan
The only hard copy will remain in a locked cabinet. Only Dr. Matthew Herbert, PI, will have 
access to the identifiers.
12.10d) An adequate plan to destroy the identifiers at the earliest opportunity consistent with conduct of the 
research, unless there is a health or research justification for retaining the identifiers or such retention is 
otherwise required by law.
 Agree
 Disagree
12.10d2) Describe the plan:
We will follow VA guidelines for destroying identifiers at the earliest opportunity consistent with 

conduct of research.
12.10e) By signing this protocol for submission, the PI is providing written assurance that the PHI will not be 
reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the 
research project, or for other research for which the use or disclosure of protected health information would 
 
be permitted by the Privacy Rule.
:  If the waiver of HIPAA authorization is for 
38 U.S.C. 7332 Information
the use of 38 USC 7332 information (applicable to drug abuse, alcohol abuse, HIV infection, and sickle cell 
anemia records), by signing this protocol for submission the PI is providing written assurance that the 
purpose of the data is to conduct scientific research and that no personnel involved may identify, directly or 
indirectly, any individual patient or subject in any report of such research or otherwise disclose patient or 
subject identities in any manner. (Ref:  38 U.S.C. 7332(b)(2)(B))
 Agree
 Disagree
12.10f) The research could not practicably be conducted without the waiver or alteration.
 Agree
 Disagree
12.10f2) Describe how the waiver/alteration enables the research to be conducted
The waiver will enable the study team to assess for necessary inclusion and exclusion criteria to 
prevent scheduling Veterans who would be ineligible for the study.
12.10g) The research could not practicably be conducted without access to and use of the PHI.
 Agree
 Disagree
12.10g2) Describe why it would be impracticable to conduct this research without the PHI described 12.10a. (v3
/8/18)
Because inclusion and exclusion criteria can be found in PHI, it important to access. This will save 
time and resources for both Veterans and research staff.
 Section 13 - Alternatives to Participation
13) Describe the alternatives to participation in this research study (see  for guidance)
?
Potential participants may seek care through the VA or in the community.
 Section 14 - Potential Risks
14) Describe any potential or known risks or discomforts and assess their likelihood and seriousness (see  for 
?
guidance)
At the initial assessment and other assessments for enrolled subjects, the interview questions and
/or questionnaires may produce discomfort or anxiety from the discussion of personal, 
emotional, or anxiety-provoking topics. The methods used in the MAP and CBT-CP groups have 
been evaluated in prior studies with patients with chronic pain, and have been shown to be well-
tolerated. Patient confidentiality will be protected to the extent permitted by law; however, there 
is always a risk of breach of confidentiality.
 Section 15 - Risk Management
15) Describe the procedures for protecting against or minimizing any potential risks/discomforts, and the 
adequacy of resources for conducting the study and resources participants may need as a consequence of the 
research.  When applicable, include detail of the following safety measures:   
(a) The type of safety 
information to be collected, including AEs; 
(b) Frequency of safety data collection; 
(c) 

Frequency or periodicity of review of cumulative safety data; 
(d) Statistical tests for analyzing the 
safety data to determine if harm is occurring; and 
(e) Conditions that trigger an immediate suspension 
of the research.  See  for further requirements.
?
The following steps are taken to minimize risk.
1) To minimize the risk of patient discomfort, confidentiality will be stressed, participants will be 
offered breaks as needed, they will be informed that they have the right to refuse to answer 
questions or to terminate their participation in the study at any time without prejudice, and 
everyone who interacts with participants will be trained and supervised. Clinical staff will be 
available if immediate in-person evaluation is required for medical or mental health issues.
2) To minimize the risk of patients becoming more anxious or depressed, every patient will be 
given a 24-hour contact phone number to call in the event of increased depression or anxiety. If 
these symptoms are detected by either the research coordinator, research assistant, or the 
person conducting the intervention, Dr. Autumn Backhaus, licensed psychologist and co-
investigator, will be available to evaluate the patient and refer to appropriate treatment and 
notify the patient’s other health care providers. When in doubt, the decision whether continued 
participation in the study is safe and clinically warranted will always be on the side of patient 
safety. Adverse events, including those unlikely to be the result of participation in the research 
(e.g., hospitalization due to an automobile accident), will be monitored at every study contact, 
including therapy as well as assessment sessions. They will be reported to the appropriate 
human subjects committees as per policy and to the Data Safety Monitoring Board for this study 
within the required time frame.
3) Veterans that report suicidal ideation at assessment or baseline/post-treatment assessment 
via the PHQ-9 or verbally will be further evaluated by the PI and Dr. Backhaus. Subsequent 
action will depend on the level of threat presented by the Veteran and may range from making a 
safety plan to implementing 5150 procedures for an inpatient hold. Further, suicidal ideation will 
be closely monitored during treatment by clinical observation and through comprehensive suicide 
risk assessments, which are part of standard VA care. Participants who develop suicidality during 
the treatment will be evaluated by the PI and Dr. Backhaus to determine whether continued 
participation in the study is safe and clinically warranted. If we and the participant believe that 
continued participation is contraindicated, an endpoint evaluation will be done and the participant 
will be referred for appropriate treatment. Appropriate treatment will depend on level of threat, 
and may include recommending a different form of psychotherapy that more directly addresses 
the predominant concern (e.g., depression, anxiety, PTSD, sleep, etc.), a referral to the 
participant’s primary care provider or psychiatrist for medication management, referral to the 
Suicide Prevention Program at the VASDHS for passive suicidality, and/or hospitalization for 
imminent threat of suicide. 
4) For participants who wish to terminate prematurely, we will request a final meeting to assess 
clinical status and safety and to review reasons for withdrawal (if the participant is willing to 
share them). Referrals for alternative mental health services, including those outside this 
protocol, will also be provided. Participants enrolled in the study may withdraw at any time 
without penalty or loss of any benefits or treatment options available to them. Investigators may 
also withdraw a participant from the study for treatment non-compliance or a newly developed 
psychiatric or medical problem if, in the opinion of myself and the study team, these factors 
interfere with the participant’s ability to participate fully in the study. If a participant discontinues 
the study for any reason, he/she will be offered and allowed access to any care in our clinics that 
any other patient not associated with the study would receive.
5) Numerous steps will be taken to protect against social risks related to confidentiality. No 
personally identifiable information (PII) will exist on the intervention platform, the LifeData app, 
or with assessment data; data will be identified via subject ID number only. In addition, the 
intervention platform and LifeData dashboard utilize secure servers to protect participants’ coded 
data and do not collect IP addresses (see Section 27.2d1). The master list linking ID numbers to 
participants’ names will be stored locally on secure, restricted-access San Diego VA research 
servers in a password-protected database only accessible on password protected computers. 
Only IRB-approved research staff that has completed training in the handling of confidential 
data, and re-trained at least once annually, will have access to participant data and files. Last, no 
individual will ever be identified by name, audio recording, or other identifiers in professional 
presentations or manuscripts related to this study.
 Section 17 - Potential Benefits
17) Discuss benefits that may be gained by the subject as well as potential benefits to society in general  (see  ?

for guidance)
Veterans may experience clinical improvement from participating in either intervention group 
(MAP or CBT-CP).
 Section 18 - Risk/Benefit Analysis
18) Discuss why the risks to subjects are reasonable in relation to the anticipated benefits to subjects and in 
relation to the importance of the knowledge that may reasonably be expected to result.
Evidence from previous studies suggests that these interventions may reduce distress and 
improve quality of life. Some participants may also feel that they are making a useful 
contribution by furthering our understanding of how to treat chronic pain. We believe the 
benefits from this study outweigh its risks.
 Section 20 - Compensation for Participation
20) Provide all details and justifications of the compensation plan.  See  for detailed requirements.
?
For both phases, participants will receive $40 for the baseline assessment, $40 dollars for the 
post-treatment assessment, and $40 for the 3-month follow-up assessment. Additionally, 
participants in Phase 1, but not Phase 2, will receive $20 for the mid-treatment qualitative phone 
interview and $20 for the post-assessment qualitative phone interview.
During Phase 2, we will also compensate participants $1 each day they log a daily homework 
exercise during the study. Participants will be compensated up to $50 total for logging in all 50 
days of homework.
 Section 21 - Responsibilities and Qualifications
Here are the identified study staff members
Matthew S. Herbert, PhD
Ariel J. Lang, PhD, Autumn L. Backhaus, PhD, Niloofar Afari, PhD, Alexandra O. Higdon, PsyD, 
Andrea Naomi Henneken, James Manchanda, Suzanna R. Purpura, BS, Jennifer S. Salamat, 
Shahrokh Golshan, PhD, Erica Martinez, Mara E. Tynan, Joel N. Fishbein, PhD, Rosi Fedra Vera
21) For each staff member listed above, describe their role and qualifications.  Also indicate which of the 
study staff are authorized to obtain consent, when applicable to the study. 
Matthew Herbert, PhD (UCSD and VASDHS) is the PI for this study. Dr. Herbert will be 
responsible for oversight of all scientific, logistical and financial aspects of the study and for 
securing and maintaining appropriate approvals. Further, Dr. Herbert will be the sole facilitator of 
the MAP intervention during both Phase 1 and Phase 2. He is a licensed clinical psychologist and 
is currently in the process of securing limited clinical privileges at the VASDHS. 
Niloofar Afari, PhD (UCSD and VASDHS) is the primary mentor on this CDA award project. Dr. 
Afari will provide mentorship during all research activities, data collection, analyses, 
interpretation, and treatment modification.
Ariel J. Lang, PhD, MPH (UCSD and VASDHS) is a co-mentor on this CDA award project. Dr. Lang 
will serve as an expert in treatment modification (Phase 1) and clinical trials (Phase 2).
Autumn Backhaus, PhD (UCSD and VASDHS) is a co-mentor on this CDA award project. Dr. 
Backhaus will complete the qualitative phone interviews during Phase 1 and assist with 
qualitative data analyses. Further, as the Clinic Coordinator for the Behavioral Medicine and 
Primary Care clinics at the VASDHS, Dr. Backhaus will be a key source for referrals during both 
phases.
Jennifer Salamat, BS (VASDHS) will be the study coordinator on this study. Ms. Salamat has 
many years of experience coordinating studies at the VASDHS and will be responsible for 

screening, administering assessments, data entry, and other office tasks.
Shahrokh Golshan, PhD (UCSD and VASDHS) is a Project Scientist in the UCSD Department of 
Psychiatry and the PI and Director of the Methodology, Biostatistics and Data Management 
(MBDM) Unit for the Advanced Center for Innovation in Services and Intervention Research. He 
will be responsible for developing and executing the analytic plan.
Alexandra Higdon, PsyD (VASDHS) is a licensed clinical Psychologist who will conduct the clinical 
interview (MINI) with Veterans, as well run treatment groups in the study.
Mara Tynan, B.A., is a graduate student in the SDSU joint doctoral program under the 
supervision of the PI. She will be aiding with administrative support and study coordination.
Erica Martinez (VASDHS WOC) Her duties will include study recruitment, data management/entry
/collection, and obtaining informed consent.
Ms. Andrea Henneken is a current WOC at the San Diego VA. Ms. Henneken will be assisting with 
study screening, data management, study procedures, and informed consent.
Mr. James Manchanda is a current WOC at the San Diego VA. Mr. Manchanda will be assisting 
with study screening, data management, study procedures, and informed consent. 
Ms. Suzanna Purpura is a current WOC at the San Diego VA. Ms. Purpura will be assisting with 
study screening, data management, study procedures, and informed consent.
Dr. Joel Fishbein is a VA postdoctoral fellow a the San Diego VA that will be assisting with study 
procedures and dissemination of study results. 
Ms. Rosi Vera is a current WOC at the San Diego VA. Ms. Vera will be assisting with data 
management and other study procedures.
 Section 22 - Bibliography
22) List relevant articles that the IRB can use to provide necessary background for the protocol. Do not 
include an extensive NIH-grant-style bibliography.  (Up to 5 recommended, but use more if needed to support 
the protocol or citations above.)
Affairs DoV: VHA Directive 2009-053: Pain Management. 2009
Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to 
explore facets of mindfulness. Assessment. 13:27-45, 2006
Bellg AJ, Borrelli B, Resnick B, Hecht J, Minicucci DS, Ory M, Ogedegbe G, Orwig D, Ernst D, 
Czajkowski S. Enhancing treatment fidelity in health behavior change studies: best practices and 
recommendations from the NIH Behavior Change Consortium. Health Psychol. 23:443-451, 2004
Bieling PJ, Hawley LL, Bloch RT, Corcoran KM, Levitan RD, Young LT, Macqueen GM, Segal ZV. 
Treatment-specific changes in decentering following mindfulness-based cognitive therapy versus 
antidepressant medication or placebo for prevention of depressive relapse. J Consult Clin 
Psychol. 80:365-372, 2012
Borkovec TD, & Nau, S.D. Credibility of analogue therapy rationales. Journal of Behaviour 
Therapy and Experimental Psychiatry. 3:257-260, 1972
Bovin MJ, Marx BP, Weathers FW, Gallagher MW, Rodriguez P, Schnurr PP, Keane TM. 
Psychometric properties of the PTSD Checklist for Diagnostic and Statistical Manual of Mental 
Disorders-Fifth Edition (PCL-5) in veterans. Psychol Assess. 28:1379-1391, 2016
Carmody J, Baer RA, Lykins ELB, Olendzki N. An empirical study of the mechanisms of 
mindfulness in a mindfulness-based stress reduction program. J Clin Psychol. 65:613-626, 2009
Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med 
Singapore. 23:129-138, 1994
Eccleston C, Williams AC, Morley S. Psychological therapies for the management of chronic pain 
(excluding headache) in adults. Cochrane Database Syst Rev.CD007407, 2009

Fox KC, Dixon ML, Nijeboer S, Girn M, Floman JL, Lifshitz M, Ellamil M, Sedlmeier P, Christoff K. 
Functional neuroanatomy of meditation: A review and meta-analysis of 78 functional 
neuroimaging investigations. Neurosci Biobehav Rev. 65:208-228, 2016
Hughes LS, Clark J, Colclough JA, Dale E, McMillan D. Acceptance and Commitment Therapy 
(ACT) for Chronic Pain: A systematic Review and Meta-analyses. Clin J Pain. 2016
Hayes SC, Strosahl K, Wilson KG: Acceptance and commitment therapy : the process and 
practice of mindful change. 2nd edition, Guilford Press, New York, 2012
Kabat-Zinn J. An outpatient program in behavioral medicine for chronic pain patients based on 
the practice of mindfulness meditation: theoretical considerations and preliminary results. Gen 
Hosp Psychiatry. 4:33-47, 1982
Krebs EE, Lorenz KA, Bair MJ, Damush TM, Wu J, Sutherland JM, Asch SM, Kroenke K. 
Development and initial validation of the PEG, a three-item scale assessing pain intensity and 
interference. J Gen Intern Med. 24:733-738, 2009
Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: 
development of a general scale. Eval Program Plann. 2:197-207, 1979
Lecrubier Y, Sheehan DV, Weiller E, Amorim P, Bonora I, Harnett Sheehan K, Janavs J, Dunbar 
GC. The Mini International Neuropsychiatric Interview (MINI). A short diagnostic structured 
interview: reliability and validity according to the CIDI. European Psychiatry. 12:224-231, 1997
McCraken, L. M., & Yang, S. (2006). The role of values in a contextual cognitive-behavioral 
approach to chronic pain. Pain, 123, 137-145.
Patel SR, Weng J, Rueschman M, Dudley KA, Loredo JS, Mossavar-Rahmani Y, Ramirez M, Ramos 
AR, Reid K, Seiger AN, Sotres-Alvarez D, Zee PC, Wang R. Reproducibility of a Standardized 
Actigraphy Scoring Algorithm for Sleep in a US Hispanic/Latino Population. Sleep. 38:1497-1503, 
2015
Sullivan MJL, Bishop SR, Pivik J. The Pain Catastrophizing Scale: Development and validation. 
Psychol Assessment. 7:524-532, 1995
Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: 
the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health 
Questionnaire. JAMA. 282:1737-1744, 1999
Wetherell JL, Afari N, Rutledge T, Sorrell JT, Stoddard JA, Petkus AJ, Solomon BC, Lehman DH, 
Liu L, Lang AJ, Atkinson JH. A randomized, controlled trial of acceptance and commitment 
therapy and cognitive-behavioral therapy for chronic pain. Pain. 152:2098-2107, 2011
 Section 23 - Sponsors and Collaborators
23) Clarify any industry financial or other support (e.g., NIH funds the study or Company X provides the 
    
assay kits).
Identify non-VA Research collaborators and their role in this protocol, including whether or not 
 
they have access to subjects or identified data.
Samantha Hurst, PhD (UCSD) is an expert in qualitative data analysis. She will provide guidance 
to the PI and help oversee qualitative assessments and analyses during Phase 1. She will not 
have any subject contact or access to identified data.
Pollyanna Casmar, PhD (UCSD and VASDHS) will assist the PI with protocol development and 
strategies to maximize participants adherence to formal meditation practice. She will not have 
any subject contact or access to identified data.
In the submission form, upload a copy of the grant, subaward, CRADA, etc. as appliable to the study.
 Section 27 - Privacy, Confidentiality, and Information Security
27a) Provide a brief description of how participant privacy and confidentiality will be protected in this study. 
Describe the circumstance under which it may be possible for a research team member to identify subjects 

and any related protections or assurances to prohibit or avoid identification. Describe how the number of 
people with access to identifiers for research purposes is limited in order to protect a participant’s privacy.
Participants will be identified by subject numbers, which will be stored separately from coded 
data. Research team members will identify participants for purposes of communication about the 
study (scheduling, assessments), documentation (e.g., CPRS notes) and safety (e.g., identifying 
SAEs or AEs). Only staff with direct contact with participants will have access to identifies.
Interview responses may be recorded by the assessor from a remote location in an electronic 
format (electronic form behind the VA firewall).
Electronic research data will include responses on self-report assessment surveys. Research data 
will be collected by phone or the LifeData app and will be entered into an electronic data set 
stored on VA secure local research servers accessible only by authorized users on password-
protected computers.
LifeData
Participants will receive a unique 5-digit LifeData ID to access the LifeData application. This 5-
digit ID will be separate from the participant's study ID, ensuring separation of identifiers and 
data. A participant crosswalk that links the study ID and 5-digit LifeData ID to the participant’s 
name and user name will be securely stored electronically in the study directory in a password-
protected Excel document. Only research staff, approved by the IRB, can access the study 
directory.
Participants will use the LifeData mobile app to access guided meditation recordings (in the MAP 
group only) and log daily practice (both MAP and CBT-CP groups). Participants will download the 
app on their personal mobile device. When participants log into the app on their phones, 
participants will be given a unique 5-digit code (LifeData ID). De-identified data collected from 
the app are encoded and encrypted before it is sent to an encrypted storage database located in 
the US. Data are encrypted before being pushed to the storage database. No data are ever 
stored on the server’s file server but always in the database. Once in the database, data are 
stored in an encrypted manner. Access to data is gated so entry is only permitted to users 
entering through the approved route (i.e., the database cannot be hacked into by guessing at 
the URL).
Additional steps to ensure confidentiality include: confidentiality training for research staff; 
identifying subjects by an arbitrary number; filing ID number key lists separately from data; 
omitting participant names from any forms; using an acronym in return addresses on any 
correspondence to participants; storing all data in locked file cabinets; securing all computers 
that store data; storing electronic data on secure servers behind firewalls. This study will use 
LifeData's "Anonymous Mode," which does not require participants to input a valid email address 
or any other identifiable information. All research staff will fulfill the educational requirements set 
forth by VA.
27.b) Entry of a CPRS 
is required when subjects will be 
 
Research Informed Consent Note
admitted as 
for research 
the study 
inpatients or treated as an outpatients 
 
and
involves research medical care or may affect 
medical care.
If a Research consent Note is required, then a 
 should also be entered for each 
Research Progress Note
procedure or intervention.
Scanning the Consent and HIPAA Authorization into CPRS is 
.  Linking the Consent to the 
not required
Research Informed Consent Note may be permitted and can be useful for trials involving the Research 
Pharmacy or when research will be performed in conjunction with clinical procedures.
For Non-Veterans, if Research Informed Consent Notes are entered, then the 
 
NOPP Acknowledgment
must be scanned into the record.  Otherwise a copy of the signed NOPP must be retained with the 
Investigator's research records and a copy sent to the Privacy Officer; see the   Help for more information.
 ?
27.b1) Is entry of CPRS notes required based on the above criteria?
CPRS notes are needed for ALL subjects 
CPRS notes are needed for SOME subjects 
CPRS notes are NOT needed for any subjects 

27c) Select the VA Sensitive Information (VASI) use category
This study does not collect or use any VASI 
This study uses but does not save, collect, copy, or record VASI 
This study does collect or record VASI 
 Section 27.1  VA Sensitive Information (VASI)
27.1a) For each type of VASI, indicate all that apply:
Indicate which of the following will be collected/recorded:
Protected Health Information (PHI)
Names
Device identifiers and serial numbers
E-mail addresses
Medical record numbers
URLs (Universal Resource Locator)
All elements of dates (except year) or any age over 89
Health plan beneficiary numbers
IP Addresses (Internet Protocol)
Telephone numbers
Account numbers
Biometric Identifiers including finger and voice print
Fax numbers
Certificate or license numbers
Full face photographic images and comparable images
All geographic subdivisions smaller than a state
Vehicle ID and serial numbers including license plate numbers
Social security numbers or scrambled SSNs (describe below)
Other unique identifying number, characteristic, or code (describe below)
27.1a1)  Describe why SSN are needed for this study
Participant payment and chart access
27.1b) Consent Forms and/or HIPAA Authorization
 Yes  
 No
27.1c) Images with personal identifiers are used for this study (x-rays, MRI images with patient names, record 
numbers, dates, etc.)?
 Yes  
 No
27.1c1) Identify where images will be stored (e.g., in the medical record, with study hardcopy records, with 
study electronic VASI records).
PI's research drive

27.1d) Photos with faces or audio video recordings are used for this study.
 Yes  
 No
27.1d1) Identify the device or devices that will be used to take/make the photographs or recordings. 
As described in section 9.11, we use the Sony ICDPX312 Digital Voice Recorder to record 
treatment sessions, which is compliant with VHA regulations and often used at VASDHS for 
research and clinical purposes.
27.1d2) Identify where images will be stored (e.g., in the medical record, with study hardcopy records, with 
study electronic VASI records
PI's research drive
27.1e) Biological specimens with identifiers are used for this study.
  Yes  
  No
 Section 27.2  Data Collection, Tools, and Resources
27.2a)  Will any specially obtained software be used?
  Yes  
  No
27.2b) Will any mobile devices (laptop, tablet, portable hard-drive, etc.) be used in support of this study?
 Yes  
 No
27.2b1) Provide details of the device/s.  Indicate whether the device is FIPS 140-2 encryption validated and 
confirm that the device is listed in the VA EIL.  Provide details regarding the nature of the data that will be 
stored or transmitted on the device and confirm whether a copy of all data will be stored on the VA network. 
Participants will have the option to use the LifeData mobile app to access guided meditation 
recordings and log daily practice (participants will also have option to access guided meditation 
via CD and log using paper and pencil, if they prefer). Participants will download the app on their 
personal mobile device. When participants log into the app on their phones, participants will be 
given unique 5-digit codes (LifeData ID). De-identified data collected from the app are encoded 
and encrypted before it is sent to an encrypted storage database located in the US. Data are 
encrypted before being pushed to the storage database. No data are ever stored on the server’s 
file server but always in the database. Once in the database, data are stored in an encrypted 
manner. Access to data is gated so entry is only permitted to users entering through the 
approved route (i.e., the database cannot be hacked into by guessing at the URL). 
Participants will be provided with a unique 5-digit LifeData ID to access the application, which 
will be distinct from participant's study ID, ensuring separation of identifiers and data. A 
participant crosswalk that links the study ID and 5-digit LifeData ID to the participant’s name 
and user name will be securely stored electronically in the study R-drive in a password-protected 
Excel document. Only research staff, approved by the IRB, can access the study R-drive.

27.2c) Does the study require use of an electronic data capture system? 
 Yes  
 No
27.2c1) Provide the web address, details regarding their security features, the nature of the data involved, and 
the research purpose.  Also include a description of how VA retains a copy of the data entered into the system.
Data collected on the LifeData mobile application are made accessible to the researchers only by 
directly accessing the secure site (https://server.lifedatacorp.com) and downloading the dataset 
as a CSV file. Data are encrypted in transmission with TLS 1.2 or greater. Datasets are never 
transmitted by email. Only study personnel communicating with Veterans (e.g., providing 
support for the mobile app; arranging appointments) will have direct access to identifiable data.
Participants will be given the option of using Qualtrics to complete baseline and post-program 
questionnaires. Information about Qualtrics is available here: https://www.qualtrics.com and 
https://vhaordfedramp.gov1.qualtrics.com. Qualtrics enables accessible and user-friendly 
collection of patient-reported outcome survey data for research studies using remote procedures. 
Study participants are sent a link to a Qualtrics survey by study staff and can complete their 
survey on any internet-connected device with an internet browser. Qualtrics is accredited by 
FedRAMP, a government-wide initiative to protect sensitive data in federal agencies, ensuring 
gold standard security for data collected through Qualtrics. Further information can be found at 
https://qualtrics.com/platform/fedramp. Researchers will access participant data using the 
Qualtrics dashboard, and all data will be identified through a numeric participant code only. Only 
approved members of the research team have access to the secure dashboard. Research team 
members will export participant data from the dashboard directly to secure VA research servers 
(i.e., the R drive).
27.2d) Will any other web-based applications be used (e.g., for recruitment, completing online questionnaires, 
or processing data)?
  Yes  
  No
27.2e)  Will coded data that excludes personal identifiers be used?   Coded data excludes 
HIPAA identifiers 
all 
(per VHA Handbook 1605.1 Appendix B), including dates
 Yes  
 No
27.2e1) Identify where the code key is stored and in what format (electronic, paper).
Coded key will be stored on paper in a locked cabinet in a locked office and in a file separate 
from data on the PI's research drive.
A participant crosswalk that links the study ID and 5-digit LifeData ID to the participant’s name 
and user name will be securely stored electronically in the study directory in a password-
protected Excel document.
 Section 27.3  Data Sharing and Transportation
27.3a) Does this study involve collecting, sharing or transporting any type of data outside of the local VA?
  Yes  
  No

 
Section 27.4  Research Record Storage and Retention
For each type of record, indicate whether it is collected for this study
27.4a) Hardcopy records/data (includes paper, pictures, film, etc.)
 Yes  
 No
27.4a1) Identify precisely where hardcopy data will be stored to include physical site, building, and room 
number, etc.  For each location identify whether VASI or non-sensitive information is stored at that 
location.  For VASI, identify how the data is secured. 
VMRF room 242 in locked cabinet
27.4a2) Are all of the above locations at VA?
 Yes  
 No
27.4b) Electronic study records (includes computer files, removable disk files, digital files, etc.).
 Yes  
 No
27.4b1) Identify precisely where 
electronic records/data will be stored to include the full map 
 
non-sensitive
drive, network location/server name, etc., and a brief description of what data/information is stored at each 
location.
R:/Herbert
Data collected on the mobile application are made accessible to the researchers only by directly 
accessing the secure site (https://server.lifedatacorp.com) and downloading the dataset as a 
CSV file. Data will then be permanently deleted from the LifeData secure server.
27.4b2) Identify precisely where 
electronic records/data will be stored to include the full map drive, 
 
VASI
network location/server name, etc., and a brief description of what data/information is stored at each location.
If no VASI is collected or recorded for this study, simply indicate that the “Study does not collect or record 
VASI”.
R:/Herbert
27.4b3) Are any of the locations described in 27.4b outside of the VA Secure Network? Note: this includes 
storage on a computer local hard drive.
 Yes  
 No
27.4b4)  Describe the storage method (e.g., in a VA encrypted laptop) and security details, including the device
/media location and ownership; describe backup procedures; identify the web applications; security features; 
and the nature of the data involved.  Identify the rationale for needing to store data outside of the VA Network 
and describe the arrangement and authority (MOU, contract, other) to permit the arrangement.

Daily tracking of homework will be collected via a mobile device and temporarily stored on the 
LifeData secure sever. Participants’ responses are always encrypted inside the app and as they 
travel from the participants’ phones to the LifeData server. Their responses are also encrypted in 
the LifeData server. All data in the LifeData server is encrypted using several techniques that 
include AES 256 bit encryption and TLS encryption 2.0 or greater.
Data being transmitted from the participant’s phone to the LifeData server is first encoded using 
Base 64 and then encrypted using AES 256 bit encryption. Synchronous and asynchronous SSL 
encryption is used
between the LifePak Builder and Manager (https://server.lifedatacorp.com), where assessment 
schedules
are created. The LifePak Builder and Manager can only be accessed after supplying a verified 
user ID and
password. 
Once downloaded to VA computers, all digital files will be stored in the study directory in the 
secure VA network.
27.4c)  Record Retention - VHA requires compliance with Records Control Schedule (RCS-10) for retention 
of electronic and hard copy records.  Following study closure, these temporary records must be retained 
for six years and then destroyed.  Longer retention may be permitted if required by other Federal regulations 
or requirements.  Will RCS-10 requirements be followed (i.e., 6-year retention)?
I will adhere to VHA Records Control Schedule-10 requirements 
I request an exception to RCS-10 requirements 
 Section 27.5  Additional Privacy or Information Security Details
Provide any other privacy or information security details here.
None
 Section 27.6  Attestations
In the event of real or suspected breach of security, the Information Security Officer, Privacy Officer, VA 
Police (if appropriate), and the individual’s supervisor will be notified within one hour of learning of the event.
 Agree
 Disagree
Study staff will be up to date on any required VHA Privacy Policy and Information Security training or they 
will not be allowed access to VA Sensitive Information.
 Agree
 Disagree
Access to research sensitive information, if any, will be removed when study personnel are no longer part of 
the research team.
 Agree
 Disagree
At least one copy of all study records (whether sensitive or non-sensitive) will be retained under VA control 
and only destroyed in compliance with the approved Records Control Schedule
 Agree
 Disagree
The VA retains ownership of the research data.  Should the investigator leave the VA, custody of the research 
records will be assigned to another investigator and the Research Service notified in writing, or custody of the 

research records will be transferred to the Research Service.
 Agree
 Disagree
 Section 28 - Protocol Association to New or Existing Project
  
28) Is this a new R&D Project?  Before you go on to complete the 
 (which is 
Initial Review Submission Form
used for attachments), please address the association of this Protocol to an R&D Committee Project.  This 
Protocol may represent a new R&D Project, or it may be an additional Protocol under an existing R&D 
  
Project (such as when a single grant supports multiple Protocols).  Will this Protocol be submitted to the 
R&D Committee as a new Project?
  Yes  
  No
 Section 29 - Existing Project Association
  
29) The associated R&D Project should already exist in the database.  Identify the R&D Project(s) that 
correspond to this protocol.
Project Status
Proposal Number
Project Title
Principal 
Investigator
No Projects are Linked to this Study
 The Protocol Application is now complete for a Protocol attached to an existing Project.
 
Next you will go on to the Initial Review Submission Form.  This form is used to collect the Application 
and any other needed attachments for submission to the IRB for review.
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