Feasibility of Remote-Delivery Interventions: Tai Chi and Wellness for PTSD and Pain in Veterans
Phase: NA
Conditions: PTSD, Pain, Chronic
Sponsor: Boston University

 
 
 
 
 
 
 
 
 
Feasibility of Remote-Delivery Interventions:  
Tai Chi and Wellness for PTSD and Pain in Veterans 
Funding Agency: National Center for Complementary and Integrative Health (NCCIH) 
Co-Principal Investigators: Barbara L. Niles, Ph.D. & DeAnna L. Mori, Ph.D. 
March 5, 2024 
 
H-42796 
NCT05693805 
Statistical Analysis Plan- pages 21-23 
 
 

 
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Abstract 
Posttraumatic stress disorder (PTSD) affects almost one quarter of military Veterans seeking care from 
Veterans Administration healthcare facilities. PTSD is associated with many health-related issues, especially 
chronic musculoskeletal pain, and is increasingly considered a systemic disorder, affecting both mind and 
body. Accessible treatments that address PTSD and chronic pain are urgently needed. Tai Chi is an ancient 
Chinese exercise that uses an integrated mind-body approach to enhance quality of life. Tai Chi delivered in 
groups has been shown to improve both mental health and physical health in patients with a variety of chronic 
conditions. However, no studies to date have examined Tai Chi for PTSD and pain in Veterans. Since the 
onset of COVID-19, interventions that can be delivered without the need for face-to-face contact are greatly 
needed. Remote mind-body interventions delivered via videoconferencing platforms can reduce barriers to 
treatment for Veterans isolated by PTSD-related avoidance, travel related challenges, or public health social 
distancing restrictions. The proposed study will evaluate the feasibility of remotely delivered Tai Chi for PTSD 
and pain in Veterans. This trial represents first steps toward a long-term goal of establishing this mind-body 
treatment to address these maladies for Veterans via a remote videoconferencing platform. In Phase One, the 
research team will adapt and do a ‘dry run’ of two existing 12-week, twice per week interventions (Tai Chi and 
a Wellness control) for delivery via videoconferencing for the study population. In Phase One, the team will 
recruit 12 participants (6 in each group) and utilize quantitative and qualitative feedback to refine and 
standardize the interventions. In Phase Two, 36 participants will be randomly assigned over 3 cohorts (n = 12 
for each cohort, n = 6 for each group) to either a Tai Chi or a Wellness group for 12 weeks with a post-
treatment and three-month follow up assessment. The feasibility and acceptability of a remotely delivered 
randomized trial of these two interventions and the assessment protocols will be determined. Feasibility will be 
quantified using rates of participant eligibility, recruitment, attrition, and adherence to the treatment and 
assessment protocols. Feasibility will be indicated (1) by the ability to meet recruitment goals, including women 
and minority participation, and (2) by having at least 75% of participants regularly attend sessions and engage 
in home practice and 70% complete post-intervention and follow-up assessments. Acceptability will be 
assessed via participants’ ratings on a standardized measure of treatment satisfaction, supplemented by 
qualitative exit interviews. Acceptability will be indicated by 70% of the participants reporting treatment 
satisfaction and credibility. Information from this trial will be utilized to design a large, randomized control study 
evaluating the efficacy of Tai Chi for improving outcomes for Veterans with PTSD and chronic musculoskeletal 
pain. The proposed study will be pivotal to establish procedures to fully evaluate a novel, accessible, 
nonpharmacologic approach for symptom management of PTSD and chronic pain in a future large-scale trial of 
Tai Chi. 
 

 
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List of Abbreviations 
VA 
 
Veterans Affairs 
VHA 
 
Veterans Health Administration  
BMC/BUMC 
 
Boston Medical Center/Boston University Medical Campus 
IRB 
 
Institutional Review Board 
SMART Goals 
 
Specific, Measurable, Attainable, Realistic, Timely 
HIPAA 
 
Health Insurance Portability and Accountability Act 
VA ORD 
 
Veterans Affairs Office of Research and Development  
CPT 
 
Cognitive Processing Therapy 
PTSD 
 
Posttraumatic Stress Disorder 
PE 
 
Prolonged Exposure 
IOM 
 
Institute of Medicine 
R&D 
 
Research & Development 
IRGT 
 
Individually Randomized Group Treatment Trial 
ICF 
 
Informed Consent Form 
CSQ 
 
Client Satisfaction Questionnaire 
CEQ 
 
Credibility/Expectancy Questionnaire 
SAE 
 
Serious Adverse Event 
BSD 
 
Behavioral Science Division 
CAPS* 
 
Clinician-Administered PTSD Scale 
PAR-Q* 
 
Physical Activity Readiness Questionnaire  
BPI* 
 
Brief Pain Inventory 
SF-36* 
 
Short Form Survey (36 questions) 
30-s STS* 
 
30-Second Sit to Stand Test 
PCL-5* 
 
PTSD Checklist 
PHI* 
 
Personal Health Inventory 
*only included in tables 
 

 
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Contents 
Protocol Title: .................................................................................................................................................... 5 
1.0 
Study Personnel...................................................................................................................................... 5 
2.0 
Introduction ............................................................................................................................................. 6 
3.0 
Objectives ............................................................................................................................................... 7 
4.0 Resources and Personnel ............................................................................................................................ 8 
4.0 
Study Procedures ................................................................................................................................. 10 
4.1 
Study Design ..................................................................................................................................... 10 
4.2 Recruitment Methods ............................................................................................................................. 15 
4.3 Informed Consent Procedures................................................................................................................ 15 
4.4 Inclusion/Exclusion Criteria .................................................................................................................... 17 
4.5 Study Evaluations .................................................................................................................................. 18 
4.6 Group Assignment and Randomization .................................................................................................. 21 
4.7 Data Analysis ......................................................................................................................................... 21 
5.0 
Reporting .............................................................................................................................................. 23 
6.0 
Privacy and Confidentiality .................................................................................................................... 24 
7.0 
Communication Plan ............................................................................................................................. 24 
8.0 
References ........................................................................................................................................... 25 
 
 
 

 
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Protocol Title:   
Feasibility of Remote-Delivery Interventions:  
Tai Chi and Wellness for PTSD and Pain in Veterans 
1.0 
Study Personnel 
 
This study will be conducted at VA Boston Healthcare System.  It is funded by the National Center for 
Complementary and Integrative Health through Boston University Chobanian & Avedisian School of Medicine. 
Below is the list of personnel working on this study. 
Principal Investigator/Study Chair: 
Barbara Niles, Ph.D.  
National Center for Posttraumatic Stress Disorder 
VA Boston Healthcare System 
 
Phone: 857-364-4128 
Email: barbara.niles@va.gov 
 
Mailing Address: 
150 South Huntington Avenue 
Boston, MA 02130 
 
Employment Status: 8/8ths VA 
 
Affiliation: Chobanian and Avedesian School of Medicine at Boston University 
 
Co-PI: 
 
 
DeAnna L. Mori, Ph.D.  
VA Boston Healthcare System 
 
Phone: 617-835-4861 
Email: deanna.mori@va.gov 
 
Mailing Address: 
150 South Huntington Avenue 
Boston, MA 02130 
 
Employment Status: WOC - hired through Boston University 
 
Affiliation: Chobanian and Avedesian School of Medicine at Boston University 
 
Co-Investigators: 
 
Anica Pless Kaiser, Ph.D.  
National Center for Posttraumatic Stress Disorder 
VA Boston Healthcare System 
 
Phone: 857-364-5309 
Email: anica.plesskaiser@va.gov 

 
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Mailing Address: 
150 South Huntington Avenue 
Boston, MA 02130 
 
Employment Status: 8/8ths VA 
 
Affiliation: Chobanian and Avedesian School of Medicine at Boston University 
 
 
Terence Keane, Ph.D.  
National Center for Posttraumatic Stress Disorder  
VA Boston Healthcare System 
 
Phone: 857-364-4551 
Email: terry.keane@va.gov 
 
Mailing Address: 
150 South Huntington Avenue 
Boston, MA 02130 
 
Employment Status: 8/8ths VA 
 
Affiliation: Chobanian and Avedesian School of Medicine at Boston University 
 
Research Assistant:  
 
 
 
To Be Named Research Assistant 
 
National Center for Posttraumatic Stress Disorder 
 
VA Boston Healthcare System 
 
 
Phone: 857-364-6262 
 
Collaborators/Tai Chi Instructors: 
 
Brian Muccio 
Body Movement Solutions 
 
Phone: 617-290-4512 
Email: bmuccio@gmail.com 
 
Employment Status: WOC – compensated through Boston University 
 
Ben Warner 
Yang Martial Arts Association Boston 
 
Phone: 617-363-9622 
Email: ben@ymaaboston.com 
 
Employment Status: WOC – compensated through Boston University 
2.0 
Introduction 

 
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Posttraumatic stress disorder (PTSD) is a debilitating psychological disorder that affects 6% of U.S. adults in their 
lifetimes1. In military Veterans seeking care in Veterans Health Administration (VHA) facilities, the prevalence of 
PTSD rises to 23%2. PTSD is associated with a host of psychosocial and health ailments3,4, including increased 
mortality5, that severely impact society at large. If symptoms remain untreated, the negative impact of PTSD on 
the functioning and medical status of Veterans may worsen over time. Current treatments for PTSD have been 
primarily concentrated on trauma-focused psychotherapies that direct the client to recall and process traumatic 
events in a controlled fashion. Two trauma-focused treatments, cognitive processing therapy (CPT)6 and 
prolonged exposure (PE)7 have been recommended as first-line PTSD treatments in clinical practice 
guidelines8. However, a large proportion of individuals with PTSD drop out of trauma-focused treatment9, 10. 
Accumulating evidence indicates that persistent symptoms of PTSD can improve with the evidence-based 
treatments described above but, for many, they do not remit. A recent review of clinical trials of CPT and PE in 
Veteran and military populations indicated that although mean scores on relevant outcome measures drop 
both significantly and substantially11, at least one third of individuals do not achieve a therapeutic response to 
treatment. Moreover, roughly two-thirds of patients involved in these clinical trials retained their PTSD 
diagnoses posttreatment.  
While PTSD historically has been considered a psychological disorder, ongoing research highlights its 
deleterious effects on physical health, and it has been increasingly considered a systemic disorder, affecting 
not only the brain and an individual’s psychological functioning, but also the entire body12, 13. Individuals with 
PTSD have been shown to be at greater risk for a wide range of medical problems, such as chronic pain3, 
cardiovascular disease14, stroke15, 16, metabolic syndrome17, certain types of cancer18, and mortality5. Recent 
research into the biological correlates of PTSD indicates that a pathological, accelerated aging process may 
also occur19, 20. Chronic pain is a common ailment in Veterans using VA services, with prevalence estimates 
around 50%21. PTSD and chronic pain have striking co-morbidity with one-another, especially in VA 
populations: 60 to 80% of Veterans with PTSD report chronic pain symptoms3, 22 and up to 50% of patients 
seeking relief of chronic pain report symptoms consistent with PTSD23-26. The presence of both disorders is 
associated with higher levels of symptomatology and disability25, 26. Asmundson and colleagues 27, 28 mutual 
maintenance and shared vulnerability model suggests that heightened physiologic arousal and sensitivity to 
anxiety may both predispose individuals to develop and fuel perpetuation of comorbid PTSD and chronic pain. 
Reductions in symptoms of one disorder may help break a cycle of mutual maintenance and then reduce 
symptoms of the other. Mind-body treatments that address both disorders can have an important synergistic 
effect to improve symptoms and functioning. Treatments that focus on general health promotion may be more 
appealing to Veterans with PTSD and have the potential to improve both physical and mental health functioning. 
Complementary and integrative treatments, such as mindfulness meditation, yoga, and Tai Chi, have received 
increasing attention in clinical settings as alternative or adjunctive treatments for PTSD. Almost all VHA 
specialized PTSD programs offer some integrative therapies29 and over 30% of individuals diagnosed with PTSD 
utilize one or more of these treatments for mental health issues30. The Institute of Medicine (IOM) called for more 
research on complementary and integrative approaches on the treatment of PTSD31 and randomized controlled 
trials have accumulated in recent years to support the use of integrative therapies such as mindfulness, yoga, 
and relaxation10. Yet, despite the increasing interest in and use of these practices, there have been no 
randomized clinical trials to date examining Tai Chi as a treatment for PTSD. 
3.0 
Objectives 
 
HYPOTHESIS: Remotely delivered Tai Chi and Wellness interventions will be feasible and acceptable 
integrative treatments for PTSD and chronic musculoskeletal pain in Veterans. 
 
The proposed two-phase feasibility trial represents first steps toward our long-term goal of establishing Tai Chi 
as an effective remotely delivered mind-body treatment for Veterans with PTSD and chronic musculoskeletal 
pain. In Phase One, we will adapt two existing 12-week, twice per week interventions (Tai Chi and Wellness 
control) for delivery via a videoconferencing platform for the study population. We will recruit 6 participants for 
Tai Chi and 6 participants for Wellness to conduct a ‘dry run’ of each condition. We will utilize quantitative and 

 
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qualitative data to refine and standardize the interventions. In Phase Two, 36 participants will be randomly 
assigned over 3 cohorts (n = 12 per cohort, n = 6 per group) to either the Tai Chi or Wellness condition for 12 
weeks with a 3-month post-treatment follow up assessment.  
 
We will accomplish the following Specific Aims:  
 
AIM 1. During Phase One, we will refine and standardize two treatment protocols for Veterans 
diagnosed with PTSD and chronic musculoskeletal pain. Tai Chi and a Wellness control condition 
intervention will be adapted for delivery via a videoconferencing platform for the population.  
AIM 2. During Phase Two, we will determine the feasibility and acceptability of a remotely delivered 
randomized trial of these two interventions and the assessment protocols.  
AIM 3. We will use information from this trial to plan and design a large, randomized control study 
evaluating the efficacy of Tai Chi for improving outcomes for Veterans with PTSD and chronic 
musculoskeletal pain. 
4.0 Resources and Personnel 
 
The proposed research will be primarily housed at the Behavioral Science Division (BSD) of the National 
Center for PTSD located at the VA Boston Healthcare System/Jamaica Plain Campus in Boston, MA.  All 
project staff working on the proposed project will either have their own office space, or access to office space if 
it is needed. All office spaces have computers, office furniture including locked filing cabinets and locked 
desks, and phones with designated phone numbers.  
For video-teleconferencing for study interventions, investigators and group intervention leaders have access 
to updated versions of a VA approved videoconferencing platform (e.g., Cisco Webex or Microsoft Teams). 
Assessment data will be collected through Qualtrics. All computers are equipped with external cameras (e.g. 
Logitech cameras). Tai Chi instructors will have access to large screen monitors where they will be able to 
see high quality images of all participants in their class at once.  
Barbara L. Niles, Ph.D., Principal Investigator, (Effort: .6 calendar months) 
Dr. Niles is a staff research psychologist at the Behavioral Sciences Division of the National Center for PTSD 
at VABHS and an Associate Professor of Psychiatry at the Boston University Chobanian and Avedesian 
School of Medicine. In the proposed study, Dr. Niles will use her expertise in post-deployment distress, mind 
body interventions, and present centered therapy to serve as PI and direct the project. She has past working 
relationships with all key personnel and has assembled a team of talented co-investigators with particular 
expertise in Tai Chi, behavioral medicine, PTSD, and statistical analyses. She will work with Tai Chi 
instructors, who they have contracted with, to develop the Tai Chi protocol and to run the Tai Chi groups. She 
will work closely to coordinate with all personnel to ensure that the study runs smoothly, manage the budget 
and ensure that all necessary IRB approvals (VABHS and BMC/BUMC) are obtained. Dr. Niles will oversee 
study recruitment, supervise the implementation of the interventions, and monitor data management and 
analyses. Dr. Niles will manage all aspects of data collection, data analyses and interpretation, as well as 
manuscript and report preparation.   
DeAnna L. Mori, Ph.D., Co-Principal Investigator, (Effort: 4 calendar months) 
Dr. Mori is a Clinical Psychologist with expertise in Behavioral Medicine and an Assistant Professor of 
Psychiatry at the Boston University Chobanian and Avedesian School of Medicine.  Dr. Mori will use her 
expertise in health behavior and promoting behavior change to assist in the development, implementation and 
running of the proposed study.  She will oversee the development and implementation of the Wellness group 
control intervention and will supervise and/or deliver the intervention.  Along with Dr. Niles, she will work with 

 
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the contracted Tai Chi instructors to develop and implement Tai Chi group for Veterans with PTSD. She will 
assist with recruitment efforts.  In addition, she will provide supervision to the research assistant and project 
coordinator, and assist with data management, analysis, and interpretation, as well as preparation of 
presentations and manuscripts.   
Anica Pless Kaiser, Ph.D., Co-Investigator, (Effort: .24 calendar months in years 1 and 3) 
Dr. Pless Kaiser is a Staff Psychologist at the Behavioral Science Division of the National Center for PTSD at 
VABHS and a Research Assistant Professor of Psychiatry at Boston University Chobanian and Avedesian 
School of Medicine. Dr. Pless Kaiser will use her expertise with all aspects of qualitative data collection, 
management, and analysis to contribute to the current project. She will work with Dr. Niles and Mori to design 
and implement individual feedback interviews. She will assist in participant recruitment and will also contribute 
time to aid with data analysis and interpretation--qualitative analysis in particular--as well as with presentation 
and manuscript preparation. 
Terence M. Keane, Ph.D., Co-Investigator, (Effort: .12 calendar months for years 1 and 2, .24 calendar 
months for year 3) 
Dr. Terence Keane is the Associate Chief of Staff for Research and Development at VA Boston Healthcare 
System and Director of the National Center for Posttraumatic Stress Disorder’s Behavioral Science Division. 
Dr. Keane is an internationally renowned expert in the field of PTSD, and he has devoted his career to 
providing the foundation for understanding PTSD.   
As a faculty member and Assistant Dean for VA Research at Boston University Chobanian and Avedesian 
School of Medicine, Dr. Keane will bring expertise in the assessment, phenomenology, and treatment of PTSD 
in many diverse populations to help in subject recruitment, data analyses and interpretation of findings, and 
manuscript preparation.  
 
Research Assistant  (Effort: 12 calendar months for year 1 and 2)  
 
The research assistant (RA) will provide informed consent at baseline and conduct the assessments for the 
study at baseline, post-treatment, and follow-up periods. Throughout the recruitment phase of the study, the 
RA will also assist investigators with recruitment efforts including making phone calls, screening participants 
over the phone, scheduling and conducting assessments, data entry, transcribing scripts, organizing 
participant data and data files.  They will also assist the PIs in maintaining approvals on the study protocol for 
IRB and R&D committees and for maintaining communication with the committees (e.g., unanticipated events, 
etc.).   
 
 
Brian Muccio and Ben Warner, Tai Chi Instructors.   
Both Mr. Muccio and Mr. Warner are Tai Chi instructors who have extensive experience working with our 
research team conducting Tai Chi mind-body research programs. In preparation for Phase I, Mr. Muccio and 
Mr. Warner will work closely with Drs. Niles and Mori to adapt an existing Tai Chi protocol to meet the needs of 
Veterans with PTSD and pain and to be deliverable using a videoconferencing system.  They will work with the 
team to further refine the protocol based on feedback and data that is obtained during Phase I.  In addition, 
they will develop a video recording for the Tai Chi intervention that participants can follow for home practice. 
Mr. Muccio and Mr. Warner have current approved WOC appointments and are credentialed to conduct 
research at VA Boston.  
All team members above have access to protected health information, and therefore will receive the required 
human subjects and confidentiality training, which includes information about maintaining data integrity and 
security. For further information, please see section 7.0 (Privacy and Confidentiality).    

 
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4.0 
Study Procedures 
4.1 
Study Design 
In the proposed trial, we plan to refine interventions that will later be used to conduct a small, randomized trial 
to provide critical information to inform a future large-scale randomized efficacy trial of Tai Chi for PTSD and 
chronic pain. Building on our combined experience the proposed study will:  
(1) Adapt, refine, and standardize two 12-week treatment protocols (Tai Chi and a Wellness control 
condition) for Veterans diagnosed with PTSD and chronic musculoskeletal pain during Phase One. Tai 
Chi and Wellness interventions will be adapted for delivery via a videoconferencing platform for the 
population and piloted in a ‘dry run’.  
(2) Determine the feasibility and acceptability of a remotely delivered randomized trial of these two 
interventions and the assessment protocols during Phase Two.  
(3) Utilize information from this trial to plan and design a large, randomized control study evaluating the 
efficacy of Tai Chi compared to Wellness for improving outcomes for Veterans with PTSD and chronic 
musculoskeletal pain. 
 
Study Interventions: 
 
Tai Chi Intervention and Instructors  
Tai Chi will be practiced using a standardized Tai Chi protocol developed for Veterans with PTSD that will be 
based on protocols that have been well-tested in our previous trials32-34, and adapted with information obtained 
while conducting the Introduction to Tai Chi for PTSD study35, and the currently running Gulf War Illness study. 
Tai Chi Instructors Brian Muccio and Ben Warner have had extensive experience conducting Tai Chi programs 
at VA Boston and are credentialed through the VABHS Research Service to provide Tai Chi instruction to 
Veterans in research studies. They will utilize their knowledge of Veterans with chronic disorders and will work 
with Dr. Wang and VA study staff to develop a suitable and replicable Tai Chi program specifically for Veterans 
with PTSD and chronic pain.  They will adapt the protocol to minimize movement across the floor (e.g., 
removing sequential stepping and instead include Tai Chi movements that involve single steps so participants 
will not encounter obstacles in their homes or move out of range of their camera and to maximize instructor 
demonstration ability on screen (e.g., providing front and side views, and close ups) to help participants see 
and learn the movements. Due to the time limited nature of the group intervention, the 108 postures of 
Classical Yang style Tai Chi will be condensed to 10 forms that are easily comprehensible and can be learned 
within 12 weeks.  Sessions will not be videorecorded to protect participant privacy.  For missed sessions, 
participants will be encouraged to practice using the video recordings that will be available on the study 
website. 
  
Wellness Control Intervention and Facilitators. We will utilize a Wellness program for the comparison group 
because this approach has been successfully used in other studies conducted by our team, including a pilot 
feasibility study conducted with Veterans with PTSD36-38. The Wellness intervention will be based on the VA 
Whole Health Program which helps individuals identify and achieve their personal health goals. The Whole 
Health Program include modules that address physical activity, personal development, healthy eating and 
drinking, stress management, relationships, personal surroundings, and spirituality. The Wellness intervention 
has been adapted with updated information from the VA Whole Health website and other resources to make it 
suitable for a population with PTSD and chronic pain. Using the SMART goals model, participants will set 
health and wellness goals each week, and discussions about ways to address potential barriers will be 
included in this condition. This group will be facilitated by doctoral level psychology staff, and/or psychology 
trainees and research staff who will be supervised by licensed and credentialed study staff. 
 
For both interventions, study staff will hold “tech sessions” with participants prior to the initial session to ensure 
that audio and video connections are adequate, and participants know how to navigate the VA-approved 
videoconferencing platform used (e.g., Cisco Webex or Microsoft Teams). In addition, participants randomized 
to the Tai Chi group will have the opportunity to provide updates on any physical issues or limitations they 
would like to make the instructor aware of. Study staff will be available by telephone to help with connectivity 

 
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and technical issues at the beginning of each session and will call participants who have not logged in to offer 
assistance.  
 
Participants may be given a water bottle after attending Tai Chi or Wellness class. The water bottles have a 
logo that says “VA Boston Health & Wellness Research” and display the circular VA emblem. These water 
bottles may be mailed to participants with a thank you note from the study team. 
 
Participants in both conditions will receive assessments at baseline and at 12 weeks (post-intervention). 
Participants in Phase Two (described below) will also receive a 3-month follow-up assessment. Weekly 
measures will be administered electronically using Qualtrics and entered into a secure database. (Please see 
section 5.5 below for more information about assessments). In addition, participants will receive phone calls 
each week where they will report on their home practice in the Tai Chi Group, and report on their SMART goals 
in the Wellness group. During these calls, participants will have the opportunity to provide feedback that may 
be used to improve their group experience. This could include topics such as: best ways to maximize 
telehealth visibility and at-home Tai Chi setup; any feedback to relay to the instructor including updates on 
physical issues or limitations; preferences for the amount of sitting vs. standing for the class; preferences for 
the amount of group discussion vs. didactic instruction, etc. This information will be recorded in an Excel 
spreadsheet that will use subject ID identifiers only and will be saved to a previously approved folder in the 
Drive: “\\r04bhsnas61\resgroups$\PTSD\DATA\RESEARCH\TeleHealth - Niles\Tai Chi 
Studies\1.NCCIH_R34”. Information will be discussed at weekly lab meetings to help the study team improve 
the TeleHealth experience for group participants. 
 
In Phase One, we will conduct a ‘dry run’ of each treatment with 6 participants for Tai Chi and 6 participants for 
the Wellness control (recruited separately for expediency).  After participants complete the group treatment, 
staff will schedule participants for a post-treatment assessment.  In addition, participants will be interviewed 
about their group experience.  These interviews will be conducted using a VA-approved videoconferencing 
platform (e.g., Microsoft Teams or Cisco Webex) without video, and participants will be called at a telephone 
number that they provide.  With participant permission to audio record, these interviews will be recorded and 
transcribed using the transcription feature available with the platform. The feedback obtained will be used to 
make modifications to our methods to optimize the delivery of the remotely delivered interventions. We will 
examine issues regarding instructor style, session content, and written materials for both interventions using 
participant feedback interviews and will modify the participant manuals, videos, and protocols as appropriate. 
The revised participant manuals will be used for Phase Two.  (See Figure 1 below). 
 
 
Figure 1: Phase One Schema 
 
 
 
 
Screening for 
Phase One 
Baseline 
Evaluation 
Parts 1 and 2 
12-week 
Evaluation 
(Post-Tx) 
Veterans with PTSD 
and Chronic Pain 
(n=6) 
Veterans with PTSD 
and Chronic Pain 
(n=6) 
Tai Chi – 12 weeks 
2x per week (n=6) 
Wellness – 12 weeks 
2x per week (n=6) 
Refinement of 
Wellness Treatment 
Protocol for Phase 
Two 
Refinement of Tai Chi 
Treatment Protocol for 
Phase Two 

 
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Randomize 
 
In Phase Two, we will use an individually randomized group treatment trial (IRGT) design.  A target goal of 36 
participants will be recruited and randomly assigned over 3 cohorts (n = 12 for each cohort, n = 6 for each 
group) to either a Tai Chi or a Wellness group for 12 weeks.  Evaluations will occur at baseline, post-treatment 
(12-weeks) and 3-month follow-up (24-weeks). (See Figure 2 below.) Both groups will be delivered using a 
videoconferencing platform.  
 
 
Figure 2: Phase Two Schema 
 
 
 
 
To ensure that our development efforts benefit from the perspectives and ideas of the Veterans with symptoms 
of PTSD and chronic pain, study staff will also interview each participant individually during the post-treatment 
(12-week) evaluation and 3-month follow-up (24-week) evaluation about their experience. Staff will utilize an 
interview guide and will elicit suggestions from the participants for optimizing the effectiveness of the 
videoconferencing platform and appeal of the program, recruitment procedure, class logistics, adherence, and 
outcome measures. These individual interviews will be conducted virtually using a VA-approved video 
conferencing platform (e.g., Microsoft Teams or Cisco Webex), and with participant permission, will be video-
recorded. Participants will be informed that the recording will be transcribed using the transcription feature in 
the platform used. Participants who decline being video recorded will be asked permission for study staff to 
take notes on their comments.   
 
The video recording and transcript data will be saved in the restricted-access study folder.   
 
We will instruct participants to maintain their regular medications and routine visits to their doctors throughout 
the study. The investigators will record any changes in medication therapy but will not be involved in any 
changes of therapy. The changes in treatment will be determined through the Electronic Medical Records and 
patient report. 
 
We will conduct this trial through the National Center for PTSD at the Veterans Affairs Boston Healthcare 
System (VABHS). Information from this trial will be used to plan and design a larger study evaluating the 
efficacy of Tai Chi in improving health outcomes in Veteran populations with PTSD and chronic pain. 
 
Participant Enrollment 
For both phases of the study, after determining preliminary eligibility via telephone screening and examination 
of electronic health record, a study staff member will schedule and conduct a remote session with each 
 
Screening for 
Phase Two 
Baseline 
Evaluation 
Parts 1 and 2 
(Pre-Tx) 
Tai Chi    
12 weeks 
2x weekly 
(target n=18) 
12-week 
Evaluation 
(Post-Tx) 
Wellness 
12 weeks 
2x weekly 
(target n=18) 
24-week 
Evaluation 
(3 mo. follow-up) 
Veterans with PTSD 
and Chronic Pain 
(target n=36) 

 
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participant via a secure videoconferencing platform approved by VA Boston for patient use (e.g. Cisco Webex, 
Microsoft Teams). Study details and alternatives to participating in the study will be reviewed. If participants 
report that they understand the study procedures and are willing to participate in the study, staff will ask 
participants to sign the ICF and HIPAA forms either electronically using DocuSign program or on a hard copy 
with a wet signature if unable to do so electronically. (See below for Informed Consent Process). 
 
Dropout/Unenrollment 
Participants will not be unenrolled in the study if they do not attend sessions.  We will use an intention-to-treat 
approach and attempt to capture all potential data at all assessments unless participants request that we do 
not contact them. (Examples: If a participant does not attend the post-treatment assessment, we will 
nonetheless contact them to ask them to complete the 3-month follow-up. If a participant gets a new job and 
cannot attend group sessions, we will nonetheless contact them for the post-treatment and follow-up 
assessments. If a participant tells us that they would like to drop out of the study and do not want to be 
contacted for additional assessments, we will not contact them again.)  A dropout will be defined as someone 
who requests that we do not contact them again for study assessments. 
Use of Email  
 
Study staff may use e-mail with participants to send: 1) instructions on how to access the remotely delivered 
intervention groups, 2) date, time and link to assessments that will be conducted remotely, and/or 3) previously 
approved participant manuals or measures to participants as needed (e.g. if postal mail is delayed or 
participants ask for copies), 3) a standardized email with instructions for the baseline assessment. 
Standard VA-approved language indicating that Veterans should not reply to these e-mails will be included in 
each e-mail. 
 
Risks to Human Subjects 
While the risks of both the Tai Chi and Wellness group protocols are minimal, there are some potential risks. 
There is potential for minor injury from the Tai Chi exercises, including muscle tears, strain, sprains, and joint 
pain. In the Wellness Group Condition, some individuals may feel discomfort discussing goals with other 
participants and staff. In addition, participants may feel some stress, frustration, or boredom while completing 
the questionnaires.  There will be a mental health professional available throughout the study for participants to 
talk with if needed.  The social risks of participating in this protocol are minimal.  There may be some 
embarrassment as participants learn to do Tai Chi or share in a group with other participants, but the 
instructors will be trained to be very sensitive to the individual needs of each participant and create an 
environment that feels safe and nonjudgmental. There is no economic risk associated with participating in this 
study.  
 
Some discomfort may occur when discussing traumatic experiences during the assessment interviews.  Drs. 
Niles, Mori, and Pless Kaiser are all licensed psychologists with extensive experience in handling emotional 
discomfort and risk management of patients with psychological disorders.  They will directly supervise the 
study staff who will be conducting diagnostic interviews and one of them will always be on call when interviews 
are taking place to handle emergencies, such as safety concerns. 
 
Protection Against Risk 
• 
Given that this study will take place fully remotely, it will be important to ensure that participants have a 
safe and private location where they will be able to participate in the study.  In order to protect the 
confidentiality of everyone in their group, participants will need to be in place where others are not able 
to see their video screen or hear the audio.   

 
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• 
Study staff will monitor participants on screen (grid view) during the classes, direct them to stay in front 
of their cameras, and take appropriate actions (e.g. calling out to them, calling by phone) if participants 
are not visible on screen. 
• 
Participants will also need to provide the address where they will be participating in the study, and 
contact information of someone who can be called in the event of an emergency.  The local police 
number will also be obtained for emergency purposes 
• 
Participants will be informed in the ICF that “to comply with laws and regulations, we may need to share 
safety-related information such as that relating to child abuse or neglect; elder or disabled person 
abuse; specific reportable diseases; harm to yourself or others”. Although there will be no questions 
asked in the assessments regarding suicidal or homicidal thoughts or intentions, if suicidal or homicidal 
intentions are disclosed, confidentiality may be broken in order for protective measures to be taken.  
Although there will be no questions asked in the assessments regarding care of children or geriatric 
persons, if a participant were to disclose child or elder abuse, appropriate agencies would be 
contacted, and participants will be so informed in the consent form.  
• 
All personnel involved in this proposed project will have completed the required ethics, human subjects, 
and confidentiality training, which include information about maintaining data integrity and security.  
Careful monitoring of participants during all phases of study participation will be conducted by the 
project staff. Participants will be instructed to contact study personnel at any time (including during the 
follow-up interval) in the event of worsening of symptoms.  Participants who begin treatment and 
experience adverse outcomes sufficient to require removal from the study will receive appropriate 
clinical care.  
• 
Drs. Niles, Mori, and Pless Kaiser are all licensed psychologists with extensive experience in handling 
emotional discomfort and risk management of patients with psychological disorders. They will directly 
supervise the study staff who will be conducting screening interviews, assessments, and intervention 
sessions. One of the psychologist investigators will always be on call during interactions with study 
participants to handle emergencies, such as safety concerns, and to make appropriate referrals for 
mental health services. Participants who are screened out due to recent suicide attempts or active 
suicidality will be referred for appropriate VA mental health services.  
• 
As in any type of treatment or clinical research program, participants’ confidentiality must be carefully 
guarded and respected.  All data with identifying information will be stored in locked files or password-
protected computer files.  Data being analyzed will be identified by subject codes and identifying 
information will be removed.  The identity of participants will not be revealed in the presentation or 
publication of any results from the project.  All project staff working on the project will be educated 
about the importance of strictly respecting participants’ rights to confidentiality and will have completed 
several training courses including proper practice in accordance with HIPAA regulations, protection of 
human subjects, and computer security. 
• 
The VABHS will provide care to participants during their enrollment in this study for any study-related 
adverse events or injuries.  Participants will not be required to pay for any services they receive as a 
subject in an approved VA research study. However, some Veterans are required to pay co-payments 
for medical care and services provided by the VA. These co-payment requirements will continue to 
apply to medical care and services (including, but not limited to, dental services, supplies, medicines, 
orthopedic and prosthetic appliances, and domiciliary or nursing home care) provided by the VA that 
are not part of this research study.  In the event that emergency care is needed during the intervention 
classes, study staff will call either the Veteran’s identified emergency point of contact, the local police 
number, or the enhanced-911 number (267-908-6605) to alert emergency services in the geographic 
area where the patient is located.   
 
Potential Benefits of the Proposed Research to Research Participants and Others 
While there are some minimal risks associated with the proposed risks, they are offset by some potential 
benefits.  Specifically, the current research shows that Tai Chi has both physical and mental health benefits 
and appears to be safe and effective in promoting balance control, muscle strength, flexibility, and 
cardiovascular fitness.  For the Wellness condition, health behaviors with known physical health benefits (e.g., 
healthy eating, improving sleep habits, engaging in physical activity) and mental health benefits (e.g., stress 
management, relationship skills) will be promoted.  

 
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4.2 Recruitment Methods 
 
Participants will be recruited in the following ways: 
1. IRB approved flyer and link to the study website may be posted on VA Facebook pages (e.g., Health 
Promotion Disease Prevention Facebook Page). Information contained in the approved flyer and 
posted on the approved website [https://www.research.va.gov/for_veterans/ptsd-pain-holistic.cfm] may 
be used by researchers, clinicians, or other interested parties outside VA Boston to inform populations 
of Veterans about this study (e.g., researchers of studies taking place at other VA sites, researchers at 
non-VA institutions, personnel from local or national Veterans organizations).  
2. IRB approved flyer and webpage developed on a VA ORD website may be distributed at public events 
for Veterans and/or at public research affiliated events (e.g., Museum of Science Annual Brain Health 
Fair).  
3. IRB approved language approved for the flyer and website may be used to promote the study in 
newsletters distributed by the VA.  
4. IRB approved flyer may be posted throughout VABHS and Vet Centers.  
5. Investigators will inform medical center staff about the study and encourage them to inform Veterans 
with symptoms of PTSD of the study or provide them with IRB-approved pamphlets.  
6. We may utilize the National Center for PTSD’s electronic referral database which consists of over 500 
potential research participants. Participants are entered into the repository on a voluntary basis, and 
written permission for future contact has already been established. The IRB of the VABHS has 
approved this recruitment mechanism (IRB#1293: “Multiproject Subject Recruitment by the National 
Center For PTSD”). 
7. IRB approved flyer and link to the study website may be posted to Veteran social media platforms such 
as Veterans Facebook groups and pages. Our research team will contact the administrator of each page 
we wish to post to and inquire if they are willing to post the study flyers, brochures, and link. If yes, the 
approved recruitment materials will be shared.  
8. Study staff may post directly to social media about research study. In addition to asking administrators of 
social media groups to post to pages and groups, study staff may announce the study on various 
Veteran social media platforms such as New England Friends of Veterans, Boston Veterans 
Collaborative and Veterans Facebook groups, directly. Our research team will post the IRB approved 
study flyer and link to our website. The study will continue to track the source of recruitment for each 
participant in order to evaluate and maximize recruitment strategies throughout the study. The ability to 
post directly will allow us to reach a wider audience as often the administrators miss the study team’s 
requests to post. 
 
If additional recruitment materials are developed in the future, we will submit those for IRB approval before 
employing them.  
 
Study staff will contact potentially eligible Veterans by telephone and describe logistical aspects of the study. 
Interviewers will answer any questions and obtain oral consent for screening to inquire about inclusion and 
exclusion criteria. Participants who are not screened out will be scheduled for a remote informed consent and 
baseline assessment during which the remaining inclusion/exclusion criteria will be evaluated. At no time will 
study staff engage in “cold-calling” to contact potential participants. 
 
To ensure success in meeting the target recruitment goal of averaging 6 participants per group (12 participants 
for Phase One and 36 participants for Phase Two), we will recruit up to 10 participants per group for a total of 
20 participants for Phase One and 60 participants for Phase Two.  
 
4.3 Informed Consent Procedures 
 

 
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One of the Investigators or a trained, research-credentialed member of the study staff will go through the 
informed consent process prior to the baseline evaluations for each patient who elects to participate.  In order 
to ensure consistent and thorough administration of the ICF process for this study, study research staff will be 
trained by the study investigators on the ICF process and will conduct mock ICF sessions with investigators 
prior to performing the ICF process with participants. The ICF process will take place on a private remote 
videoconference (e.g., Cisco Webex, Microsoft Teams).    
 
At the scheduled ICF and initial baseline assessment, a study staff member will confirm inclusion and 
exclusion criteria reported at the initial phone screening call and verbally review each section of the ICF and 
HIPAA forms with the Veteran. They will explain alternatives to participating in the study, such as treatment 
available at VA Boston Healthcare System. The study staff member will answer any questions about the study 
the participant might have. Participants will be given as long as they like to consider participation. If they report 
that they understand the study procedures and are willing to participate in the study, staff will ask participants 
to sign the ICF and HIPAA forms electronically using the DocuSign program. This method of informed consent 
and documentation has been approved for other studies by the VA Boston IRB.  If DocuSign is unavailable or 
the participant does not want to sign the form electronically, study staff will send two hard copies of the ICF to 
the participant in advance of this meeting.  Participants will sign the hard copies and will then be asked to hold 
the signed signature pages of the ICF and HIPAA forms up to the screen so study staff can capture screen 
shots of the signed forms to save in secure files. Given the variability in screen-shot quality, study staff will also 
instruct the veterans to send signed copies of the ICF and HIPAA back to Dr. Niles for VA Boston study 
records and to keep a signed copy of the forms for their own records. 
 
After the informed consent document is signed, additional screening procedures covered in the informed 
consent document will be conducted prior to randomization. The investigators consider this consent process to 
be an ongoing process maintained throughout the study to provide participants with a continued understanding 
of the protocol, their participation, and their rights as human research subjects.  
 
All discussions concerning consent will emphasize that participation is voluntary and that the participant’s 
medical care/benefits will be unaffected by his or her decision regarding participation. Participants will be 
informed that they will be compensated for time and inconvenience at a rate of $25 for each of the two baseline 
assessment sessions and $65 for the post-treatment assessments. Those participants who are recruited for 
Phase Two will be compensated $80 for the 3-month follow-up assessment. Participants will also receive $5 
for completing the weekly measures, $5 for the weekly phone calls with study staff who track home 
practice/goals, and $5 for each intervention group session they attend for a grand total of up to $355 for those 
in Phase One and $435 for those in Phase Two. In the event that a participant completes the baseline 
assessment twice (see paragraph below for scenario where this could occur), the potential total compensation 
for Phase Two could be $485. This remuneration for time, inconvenience, and ongoing commitment is not so 
high as to coerce an individual to participate who would otherwise not participate. Compensation will be 
provided in one of three ways: 1) gift cards to a national chain store (e.g., Target or Walmart) which would be 
mailed to them, 2) electronic funds transfers to the participants’ bank accounts (bank account information 
including bank routing number, account number, bank name, account type will need to be confirmed), or by 3) 
debit card payments using Direct Express (participants will need to request a debit card or provide account 
information if they already have one) and payments will be made directly to the debit card. If gift cards are sent 
to participants, a templated thank you letter with a breakdown of the gift card payments will be mailed with the 
gift cards to ensure participants can keep track of (for their own records) the payments they have received 
throughout the study and what they were for.  
 
Some participants may complete the consenting process but not complete the entire baseline assessment in a 
timely manner due to illness or other unforeseen reasons. If a participant completed or partially completed a 
baseline assessment, but is not able to participate in the upcoming cohort, they may be considered for a later 
cohort. In this case, the participant will be reconsented, baseline measures will be readministered, the 
participant will be compensated for the additional baseline assessment, and the original baseline measures will 
not be included for analysis. 
 

 
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[Note: If there is a delay before the second baseline session and the only measure the participant is asked to 
re-take is the sit to stand task (see below under Study Evaluation for explanation of that), no additional 
compensation will be provided. This measure takes approximately 5 minutes to administer.] 
 
There will be no circumstances under which a legal authorized representative will provide consent for a 
participant enrolled in the study. Participants will also be informed that if suicidal intentions, or child or elder 
abuse are disclosed, confidentiality may be broken for protective measures to be taken. 
4.4 Inclusion/Exclusion Criteria 
The primary inclusion criteria for this study will be Veterans with PTSD and chronic musculoskeletal pain who 
agree to abstain from initiating other formal treatments for PTSD during the study period. A more complete 
description of both the inclusion and exclusion criteria is located in the table below.  
 
An initial screening will take place over the telephone (or in person if the potential participant stops by the 
research office) to determine if the veteran meets initial inclusion criteria.  (Please see Telephone Screening 
Form.)  Telephone screening forms for veterans, including those who do not meet all inclusion criteria, will be 
completed digitally and kept in a secure data folder on our shared drive (specified below). In the event that we 
seek and gain IRB approval to amend our inclusion criteria at a future date (e.g. loosen the criteria to include 
more veterans), we will submit a HIPAA waiver for IRB approval to allow us to access the forms for those who 
did not originally meet eligibility criteria and to re-contact those individuals who may now be eligible to 
participate. Additionally, participants who are deemed ineligible after screening will be asked if they would like 
to be added to the Subject Recruitment Database, in which case they will be mailed the relevant form at a later 
date. 
 
Final eligibility for the study will be determined after the baseline assessment is completed. The informed 
consent process will occur prior to initiating the baseline assessment. The CAPS-5 interview to determine the 
PTSD case definition will take place during part two of the baseline assessment after the informed consent 
process in part one of the baseline assessment. If veterans do not meet the diagnostic criteria on the CAPS-5, 
they will be determined ineligible at this point. In addition, if information comes to light during the baseline 
assessment that indicates ineligibility (e.g., veteran mentions they recently began a new treatment or had a 
psychiatric hospitalization), they will not be added to the list of participants to be randomized. We anticipate 
that a small number of veterans may be screened out after the informed consent process and prior to 
randomization. These veterans will be compensated for participation in the baseline assessment but will be 
deemed ineligible for the remainder of the study and will not be randomized. 
 
Inclusion criteria 
Exclusion criteria 
- 
Veteran status as indicated by self-report 
- 
PTSD Case Definition. Veterans who 
meet DSM-5 diagnostic criteria according 
to DSM-5 diagnostic algorithm for current 
PTSD as assessed on the Clinician-
Administered PTSD Scale for DSM-5 
(CAPS-5) will be eligible for the study. A 
diagnosis of current PTSD requires: a 
traumatic stressor (Criterion A) and the 
requisite number of symptoms at a 
severity level of 2 or higher in each 
symptom cluster. Each symptom is rated 
on a severity scale of 0 (no symptoms) to 
4 (extreme), with 2 representing clinically 
significant and clearly present 
symptomatology. An individual must 
endorse at least one reexperiencing 
(Criterion B) symptom, at least one 
- 
Lacks the capacity to provide consent.  
- 
Diagnosed major medical disorder (e.g., 
neurological disorder, cancer, chronic 
infectious disease or liver disease) or has a 
moderate or severe traumatic brain injury, 
which could otherwise explain the health 
symptoms or interfere with their ability to 
safely engage in Tai Chi exercises.  
- 
Change in psychotropic or pain medication 
during the past month. This will minimize 
amount of symptom change due to 
medication alterations. (Once enrolled, 
medication changes are nonetheless 
expected and will be monitored.) 
- 
Regular current Tai Chi, formal mindfulness 
meditation program, or yoga practice, 
defined as at least three hours per week for 
more than three months. (Veterans with 

 
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4.5 Study Evaluations 
Our primary evaluation measures for this feasibility trial will be measures of feasibility, acceptability, and 
adherence. Our secondary measures will be administered to pilot the administration of psychometric measures 
for future trials.  Evaluations will be conducted during two baseline sessions (prior to randomization), at post-
treatment (12-week evaluation), and (for Phase Two only) at 3-month follow-up (24-week evaluation). A VA 
approved videoconferencing platform (e.g., Cisco Webex, Microsoft Teams) will be used to administer the 
measures that need to be conducted by staff (see below). Study staff will also instruct participants regarding 
how to complete the questionnaires collected electronically using the Qualtrics program and will be available to 
answer participants’ questions in order to facilitate completion. Post-treatment and 3-month follow-up 
assessments will be completed in one or two sessions. 
avoidance (Criterion C) symptom, at least 
two symptoms of negative alterations in 
cognition and mood (Criterion D), and at 
least two hyperarousal (Criterion E) 
symptoms. In addition, these symptoms 
must have been present for at least one 
month (Criterion F) and cause either 
clinically significant distress or functional 
impairment (Criterion G). 
- 
Chronic pain as indicated by complaints of 
musculoskeletal pain in one or more body 
regions for six months or more.  
- 
Willing to abstain from initiating evidence-
based and mindfulness-based 
psychotherapy for PTSD, pain and related 
disorders until completion of the study (i.e., 
prolonged exposure, cognitive processing 
therapy, cognitive-behavioral treatment for 
insomnia or pain, acceptance and 
commitment therapy, dialectical behavior 
therapy, mindfulness-based stress 
reduction). Once enrolled, however, if 
other providers prescribe treatment or if 
participants require additional intervention 
(such as to manage a safety or substance 
abuse condition), treatment will be 
allowed, and appropriate referrals will be 
made.  Individuals who are currently 
engaging in short-term (e.g., 12-week 
protocol) evidence-based treatment will 
not be eligible until treatment has ended. 
- 
Access to internet and home computer or 
tablet device that will allow telehealth 
delivery of intervention. 
- 
Available to attend either intervention 
group at the times they are scheduled. 
- 
Enrolled and eligible to receive care in 
Veterans Health Administration (VHA).  
We will facilitate enrollment for Veterans 
not currently enrolled but wish to take part 
in the study. 
 
prior experience who do not currently 
engage in regular practice at this level will 
be eligible.) 
- 
High risk from a mental health perspective 
e.g., recent psychiatric hospitalization, high 
risk flag or a note in their VA electronic 
health record indicating current high-risk 
factors, entered into a drug or alcohol 
detoxification or rehabilitation program, or 
attempted suicide within the previous year 
as indicated in their VA electronic health 
record. 
- 
Pregnant or breastfeeding or plans to 
become pregnant within the year, assessed 
via self-report. Enrollment of pregnant or 
breastfeeding participants could potentially 
complicate outcomes, as new symptoms 
are likely to arise during the course of the 
intervention that are attributable to the 
pregnancy or breastfeeding and not the 
intervention or symptoms related to PTSD.  
- 
Reports difficulty standing on feet for the 
majority of a Tai Chi class (approximately 
60 minutes). 
- 
Reports that they have been told by a 
doctor that they should not engage in 
physical activity unless recommended by a 
medical team. 
- 
Reports other reason they cannot safely 
participate in physical activity. 
- 
Concurrent participation in another clinical 
trial 
- 
Participants who engage in behavior that is 
disrespectful or disrupts the group may be 
terminated from the study. 
- 
Participants who demonstrate evidence of 
falsifying data may be terminated from the 
study 

 
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In order for the baseline data to be valid, the baseline assessment should be completed within approximately 
one month prior to group assignment. The sit to stand task (planned to be administered at the first baseline 
session) may be readministered closer to the group start date if delays have taken place. Also, if participants 
were unable to complete the sit to stand task at the first baseline assessment (e.g. if they do not have an 
appropriate chair available), it may be completed later. 
 
 
 
A. Primary Measures: Feasibility and Acceptability, Measures of Participant Satisfaction and 
Adherence 
Measure 
Description, Citation, and Metric for Current Study 
The Client Satisfaction 
Questionnaire (CSQ) 
The CSQ assesses participants satisfaction with patient care39. Administered at 
post-treatment, and 3-month follow-up (for Phase Two only) via Qualtrics. There are 
8 original items that focus on client satisfaction and 3 supplementary items that 
measure global life satisfaction, general health status and global effectiveness of 
services received. 
Metric: At least 70% of participants will have a mean item-score of 3 or greater on 
the 1-4 scale of the 8 original items at post-treatment.      
Participant Adherence 
Attendance/Compliance 
Study staff will monitor number of missed sessions, reasons given for missing 
sessions, and completion of assessments.  
Metric: 75% of participants will attend at least 70% of the treatment sessions. 70% 
of participants will complete all assessments (baseline through follow-up). 
Credibility/Expectancy 
Questionnaire (CEQ). 
Assesses participants’ perceptions of treatment credibility and outcome expectancy 
in clinical outcome trials.41  
Administered at weeks 1,2,4, and 9 via Qualtrics 
Metric: At least 70% of participants will report a mean item-score of 6 or greater on 
the 1-9 scale by week 4 for both credibility and expectancy  
Weekly Log Sheets 
Participants will keep logs of homework/practice that will be reported via telephone 
to the project coordinator weekly during the 12-week intervention period. In the Tai 
Chi condition, they will record the number of minutes per day spent on home 
practice. In the Wellness condition, they will record weekly goals. 
Metric: At least 75% of participants will complete at least 70% of weekly log sheets. 
 
B. Secondary Measures Outcome Measures to Be Administered to Ascertain Burden and Calculate 
Intra-Class Correlation Coefficients 
           Administered at baseline, post-treatment (12-weeks), and 3-month follow-up (24-weeks), for Phase Two 
only) (Note that CAPS-5 will only be administered at baseline and post-treatment for Phase Two) 
Construct and Measure 
Description and Citation 
PTSD severity:  
Clinician Administered 
PTSD Scale – 5th 
Edition (CAPS-5) 
The CAPS-5 is a structured diagnostic interview for PTSD administered by study 
staff.42  The interviews will take place using a VA approved platform (e.g., Cisco 
Webex or Microsoft Teams).  During Phase Two, this diagnostic interview will be 
video-recorded, with participant permission and administered at baseline and post-
treatment.  The recordings will be used to ensure reliability of assessor ratings.   
Pain: 
The Brief Pain Inventory 
– Short Form (BPI) 
The BPI is a self-report measure that examines pain intensity and interference with 
functioning in various life domains.43,44 Administered via Qualtrics. 43, 44  
Medical Outcomes Study 
Self-Reported Measure 
of Health Status: 
36-Item Short Form 
Survey (SF-36) 
The SF-36 is a 36 item self-report questionnaire that assesses self-perception of 
health status in the following domains: physical functioning, role limitations due to 
physical and emotional factors, social functioning, bodily pain, general health, 
vitality, and mental health.45 Administered via Qualtrics.  

 
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Physical Functioning: 30 
second Sit to Stand Test 
(30-s STS) 
The 30-s STS is an objective measure of lower body strength.46 Administered by 
study staff over videoconference platform.  
 
 
C. Weekly Outcome Measures to Be Administered to Ascertain Burden 
           Administered weekly using Qualtrics throughout intervention period (both Phase One and Phase Two) 
Construct and Measure 
Description and Citation 
PTSD: 
The PTSD Checklist for 
DSM-5 (PCL-5) 
The PCL-5 is a 20-item self-report measure that examines symptoms of DSM-5 
posttraumatic stress disorder criteria over the past week.47,48  Administered via 
Qualtrics.   
Pain: 
The Brief Pain Inventory 
– Short Form (BPI) 
In addition to being administered at the primary assessment points (baseline, post-
treatment, 3-month follow-up) as noted above, the BPI will be administered weekly 
during the intervention period using Qualtrics. 43, 44 43,44  
 
 
 
 
D. Other Descriptive Measures  
Demographics 
This information will be used to provide a comprehensive description of the sample of 
Veterans and variables may be used as covariates in sensitivity analyses.  
Administered at baseline. Administered via Qualtrics. 
Life Events Checklist 
Extended Self Report 
The LEC-5 will be used to establish Criterion A for the CAPS-5 interview with study 
staff.  Administered at baseline. Administered via Qualtrics.  
Psychoactive and Pain 
Medication Usage 
A list of current, prescribed psychoactive and pain medications will be obtained 
through VA electronic medical record and verified through participant self-report at 
baseline and updated at subsequent assessments. For each prescribed medication, 
staff will ask whether participants have been taking medications as prescribed during 
the previous period and will document lapses and changes.  
 
E. Other Measures  
Telephone Screening 
Form 
Potential participants will be screened over the telephone by study staff to determine if 
they meet inclusion criteria.  Individuals who meet this initial criteria will be scheduled 
for the baseline assessment where the Informed Consent will be reviewed and 
signed.  
Feedback Interview 
Form 
 
Semi-structured interview developed to obtain feedback from each participant about 
their participation in the study.  This feedback will be obtained through interviews that 
will take place at post-treatment (12-weeks) and, in Phase Two, at 3-month follow-up 
(24-week evaluation). Interviews will take place using a VA approved platform (e.g., 
Cisco Webex or Microsoft Teams), and with participant permission, will be video 
recorded and transcribed.  
Additional Feedback 
Questions 
Some additional satisfaction items will be administered via Qualtrics to address 
participants’ response to the specific interventions used in this study. 

 
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4.6 Group Assignment and Randomization 
For Phase 1, participants will be assigned to groups based on when they are enrolled. Once we have a group 
of 6-10 veterans, we will begin one of the groups (either Tai Chi or Wellness based on instructor availability).  
We then will gather another 6-10 participants for the next group.  
For Phase 2, randomization will occur after baseline assessments for all members of the cohort are completed. 
A study staff member will make a list of available cohort participants in order of completion of initial telephone 
screening. The cohort list is password-protected and unavailable to the rest of the staff. Another staff member 
will then use the list randomizer from Random.org (https://www.random.org/lists/) to create a randomly ordered 
list of the group assignments equally distributed between Tai Chi and Wellness and equal to the size of the 
cohort, rounding up to an even number. The list of group assignments is then matched with the numbered list 
of participants. Study staff then call participants to inform them of their condition assignment and the days and 
times of the group intervention to which they have been assigned. 
4.7 Data Analysis 
Sample Size Calculation 
In this pilot study we are primarily concerned with feasibility and data gathering with a target goal of 48 
participants (12 in Phase One and 36 in Phase Two). Based on our prior experience, we feel confident we can 
reasonably recruit 48 participants during the study period over 4 waves of recruitment for these intensive (twice 
per week for 12 weeks) interventions. From our previous experience with remote Tai Chi groups, we found 6 to 
be an optimal group size as it permitted the instructor to see each participant well on the video screen to 
provide individualized attention and facilitated a feeling of camaraderie among the participants. For this study’s 
primary outcomes of satisfaction (measured by the CSQ) and credibility of the interventions (measured by the 
CEQ), we anticipate that more than 70% of the participants will meet the metrics identified. If 26 of 36 
participants enrolled in Phase Two meet the metric the estimated completion percent would be 72% (95% CI: 
55% to 86%). For the primary outcomes of compliance/attendance (measured by sessions and assessments 
attended), and completion of weekly log sheets, we anticipate that more than 75% of the participants will meet 
the metrics identified. If 28 of 36 participants enrolled in Phase Two meet the metric the estimated completion 
percent would be 77% (95% CI: 60% to 89%). 
 
Phase Two of this trial will use an individually randomized group treatment trial (IRGT) design, where individual 
participants are randomized to one of the interventions and the interventions are delivered in small groups. In 
Phase Two, after a cohort of approximately 12 eligible participants are identified, research staff will contact 
eligible participants by phone to confirm that they still wish to participate in the study and are able to attend 
sessions at the days and time of the interventions. Once confirmed, half will be randomly assigned to each of 
the two conditions (Tai Chi and Wellness).  If we are unable to recruit 12 Veterans over a one-month 
recruitment push, we may randomize a smaller cohort of Veterans so that Veterans who have agreed to 
participate will not be kept waiting too long to begin the interventions. 
If we are successful in recruiting more than 12 Veterans over the recruitment push, we may randomize up to 
20 Veterans to help ensure that we will end up with an average of 12 Veterans who are able to participate in 
the groups.  Random assignments to condition will be managed by study staff who will generate the 
randomization scheme.  Participants will be randomized in order of completion of initial telephone screening. 
Personal Health 
Inventory (PHI) 
The PHI is a 12-item self-report measure that assesses participants’ relationship with 
8 areas of health and well-being from the VA Whole Health Circle (model that is used 
in the Wellness Intervention) including relationships, sleep, exercise, food and drink, 
personal development, spirituality, surroundings, and power of the mind.49 This scale 
will be administered using Qualtrics to participants who are in the Wellness 
Intervention to measure potential growth across these 8 areas of self-care over the 
course of the study. It will be administered during the intervention at week 2 and week 
12 in Phase 1, and also at the 3-month follow-up (24-weeks) in Phase 2. 

 
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Study staff will then call participants to inform them of their condition assignment and the days and times of the 
group intervention to which they have been assigned. 
 
 
AIM 1. During Phase One, we will refine and standardize two treatment protocols for Veterans diagnosed with 
PTSD and chronic musculoskeletal pain. Tai Chi and Wellness interventions will be adapted for delivery via a 
videoconferencing platform for the population.  
Using information gathered from group and individual feedback sessions, we will edit and refine the participant 
manuals to optimize remote delivery issues such as sound quality, ability to see and follow instructors, 
instructor ability to view Veterans, and connectivity difficulties. We will also inquire about frequency, duration, 
and time of day of sessions, class size, ease of use of printed materials and log sheets. We will use adherence 
and satisfaction data and qualitative feedback to modify the interventions and improve the protocol before 
moving to Phase Two. 
 
AIM 2. During Phase Two, we will determine the feasibility and acceptability of a remotely delivered 
randomized trial of the two interventions and the assessment protocols.  
Feasibility and acceptability will be quantified by evaluating rates of eligibility, enrollment, satisfaction, 
adherence, retention, and credibility expectancy, and compliance with home practice. Specifically: 
o Successful eligibility and enrollment will be indicated by our ability to meet overall recruitment 
goals (in addition to successfully recruiting a representative sample of women and minorities as 
projected in the Enrollment Table).  
o Treatment satisfaction will be indicated if at least 70% of participants have a score of 3 or 
greater (corresponding to mostly or very satisfied) on the 1-4 scale of the CSQ.  
o Adherence and retention will be determined by meeting the metric of at least 75% of participants 
attending at least 70% of the treatment sessions and 70% of participants completing all baseline 
and follow-up assessments.  
o Credibility will be measured by the CEQ with at least 70% of participants reporting a credibility 
rating of 6 or greater on the 9-point scale.  
o Compliance with home practice will be measured by 75% of participants completing 70% of 
weekly log sheets.  
 
Measures to be examined for participant burden for the larger trial will assess PTSD symptom severity, pain 
levels, global health, and physical functioning at baseline, post-treatment and (for Phase Two only) 3-month 
follow-up. In the qualitative feedback interviews, we will further assess these issues to determine if changes 
are needed regarding recruitment, retention, adherence, and participant burden. If we do not meet the 
feasibility goals, we will reevaluate to make refinements before developing protocols for a future large trial.  
 
AIM 3. We will utilize information from this trial to plan and design a large, randomized control study evaluating 
the efficacy of Tai Chi compared to Wellness for improving outcomes for Veterans with PTSD and chronic 
musculoskeletal pain. 
The Tai Chi and Wellness control protocols developed, revised, and finalized as part of the proposed project 
will be used in a future larger study designed to evaluate Tai Chi for PTSD and chronic pain. The current study 
will provide preliminary data on feasibility, acceptability, adherence, and participant burden. In addition, the 
preliminary trial will allow us to work out technology issues to optimize our use of remote videoconferencing 
and to develop methods to maximize efficiency for research staff that will help guide the design of this large-
scale trial. If we fall short of recruitment and/or retention goals, we will use the information gathered during the 
qualitative interviews and study staff experience to make further refinements to our remote protocol (e.g. 
providing additional resources for assistance with technology issues for participants, providing videocams or 
tablets to all participants, assistance with home setup, etc.). 
 
Qualitative data will be analyzed using an iterative coding process. Individual Interviews will be transcribed and 
then analyzed by a committee of study staff using a general inductive approach. Raters will independently 
code several transcripts to identify themes, starting with specific categories such as positive experiences, 
negative experiences, areas for improvement, and other. Next, the committee will meet to review identified 
themes, to discuss discrepancies, and to refine the suggested coding rubric. Raters will code the remaining 

 
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transcripts and continue to meet until consensus is reached on the identified themes and on the distribution of 
participant quotes under appropriate themes. The committee will then choose participant quotes that best 
represent the identified themes. This information will be used to inform refinement of the Tai Chi and Wellness 
protocols to be used in future studies.  
5.0 
Reporting 
Monitoring of safety and data quality in the proposed study will be the responsibility of all personnel on the 
project, under the guidance and supervision of the Principal Investigators, and with the oversight of an 
Independent Safety Monitor, John Otis, Ph.D.  Dr. John Otis is an expert in the field of pain management and 
behavioral medicine from VA Boston Healthcare System and Boston University Chobanian and Avedesian 
School of Medicine.  He has a strong track record of conducting research on non-pharmacological pain 
management interventions and has worked with and developed interventions for Veterans with co-morbid pain 
and PTSD.  Given his experience in working with the specific population we will be recruiting for this study, and 
his expertise in non-pharmacological interventions for pain and PTSD, he will be an ideal Independent Safety 
Monitor for this study.  Dr. Otis will review our participant safety processes upon initiation of the study and will 
assess the progress of this study at least once a year. This will include evaluating the processes that are 
delineated below.  
 
The VA Boston and Boston Medical Center/Boston University Medical Campus (BMC/BUMC) Institutional 
Review Boards will approve the Statement of Informed Consent for the study and provide institutional oversight 
of data and safety issues. The study protocol will be approved prior to recruiting or consenting any participants.  
Moreover, the study will be reviewed on an annual basis by the VABHS IRB committee. Each participant will 
sign the Informed Consent Form prior to participating in the study. To ensure participant safety, once 
participants are enrolled in the study, study staff will immediately report all adverse and serious adverse events 
to one of the PIs. The PI will, per standardized procedures, report them to the VA and BMC/BUMC IRBs for 
their review. With regard to monitoring of data quality and protected health information, all required personnel 
proposed for this project will have the required human subjects and confidentiality training, which includes 
information about maintaining data integrity and security.  Confidentiality will be guarded using established 
procedures such as storing data in locked cabinets within locked offices or locked data rooms, coding by study 
identification numbers rather than any personally identifying information to avoid revealing the identity of 
subjects, and aggregating data across participants.  The key linking names and study identification numbers 
will be kept separately from the data sets with limited access by study personnel. Only study personnel will 
have access to the data sets on protected servers. Data will not be removed from the VA protected 
environment at any time, except by methods approved through a Data Use Agreement. The investigators may 
seek a Data Use Agreement at a later date to transfer deidentified data for analysis. Data will be securely 
transmitted using VA approved methods.  Oversight of all aspects of data management will occur with the PIs. 
Questionnaire data will be collected using the Qualtrics survey tool for online data collection or will be collected 
by study staff through participant interviews and record reviews. On study forms, participants will only be 
identified using the participant’s ID number (no names or identifying information will be on the forms). Data 
collected by study staff will be entered in the computer independently by trained data entry staff, and data entry 
discrepancies will be corrected by the project coordinator, based on source documents.  The quality of the data 
will be monitored on an ongoing basis. Data quality will be monitored by inspection of the completed forms by a 
research assistant and any problems detected will be discussed with the PIs.  Electronic data will be stored in 
password-protected database files on a password-protected network system.  Only the study staff will have 
access to the data. Telephone screening forms for Veterans who are ineligible or are eligible but decide not to 
participate will be kept in a secure electronic file separate from data collected on enrolled participants and will 
not be accessed by study staff after being placed there. 
 
Records will be destroyed in accordance with the VA Record retention schedule. Records will be destroyed, 
when applicable, in the following manner: All research data for this study that is maintained on electronic 
storage and memory devices (e.g., computers, laptops, CDs, recordings, etc.) will be destroyed in a manner in 
which it cannot be retrieved.  All paper records will be destroyed by shredding. Research records and the 

 
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information within them will not be used for any purpose other than that which is described in the study as 
approved by the VA IRB. 
 
In the proposed study we will use the FDA definition of adverse events (AE) and serious adverse events 
(SAE). Any SAE, whether related to study intervention or not, will be reported within the required 5-day 
reporting period to the VA IRB and will be followed by an additional letter detailing the nature of the SAE. In the 
event that a participant either withdraws from the study or the PIs decide to discontinue a participant due to a 
SAE, the participant will be monitored by the investigators until (a) a resolution is reached (e.g., the problem 
has resolved or stabilized with no further change expected), (b) the SAE is determined to be clearly unrelated 
to the study intervention, or (c) the SAE results in death. Outcomes of SAEs will be regularly reported to the VA 
IRB. A summary of all AEs and SAEs that occurred during the previous year will be included in the annual VA 
IRB renewal.   
 
Unanticipated Problems will be submitted to the BMC/BUMC IRB within 7 days; AEs/SAEs will be submitted to 
the BMC/BUMC IRB every three years during the required status check-in for minimal risk research. 
 
We will specifically outline in the Informed Consent Forms the availability of emergency services to participants 
who may seek them during and after normal working hours.  In the Informed Consent Form, we will provide 
specific information about emergency contacts.  Participants are instructed to contact Dr. Niles or Dr. Mori 
during working hours.  
6.0 
Privacy and Confidentiality 
In order to protect participant privacy, all personnel proposed for this project will have the required human 
subjects and confidentiality training, which includes information about maintaining data integrity and security.  
Confidentiality will be guarded using established procedures such as storing electronic data in password-
protected database files on a password-protected network system, and hard copy data will be stored in locked 
cabinets within locked offices or locked data rooms.  Data will be coded by study identification numbers rather 
than any personally identifying information to avoid revealing the identity of subjects, and data will be 
aggregated across participants.  As noted above, the codes that link names and their ID numbers will be kept 
confidential by the PI in a password protected file on a password-protected network system.  Only study 
personnel will have access to the data, and the datasets will be kept on protected servers.  Oversight of all 
aspects of data management will occur with the PI and Co-Is. 
 
Research records and the information within them will not be used for any purpose other than that which is 
described in the study as approved by the IRB. 
 
In order to ensure that participants are adequately informed about the protocol and any anticipated risks, 
research staff will carefully review the IRB approved Informed Consent with the participants.   A summary of 
the potential risks to participants will be provided, and study staff will provide participants with an opportunity to 
ask questions to insure an adequate understanding.   
 
This study is funded by the NCCIH, one of the institutes of the National Institute of Health (NIH). Certificates of 
Confidentiality (CoCs) are automatically deemed to be issued for any NIH-funded clinical trials. The NIH does 
not issue a physical CoC for NIH-funded research projects.  
7.0 
Communication Plan 
 
The PIs will provide oversight of the entire research project, including the development and implementation of 
the study. Drs. Niles and Mori have been working collaboratively for over a dozen years and have 
successfully and jointly conducted two small pilot studies relevant to the proposed project, along with a 
currently running larger randomized controlled trial where the efficacy of Tai Chi and Wellness interventions 

 
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are being investigated with a population of Veterans with Gulf War Illnesses. They are a strong team that 
provides seamless and comprehensive coverage for the studies they manage. As both PIs have competing 
responsibilities, sharing interchangeable roles has enhanced their ability to be fully responsive to any 
administrative or safety issues that arise with their projects. When a question or issue comes up, they can 
respond quickly and provide immediate resolution. Consequently, they are viewed as a highly responsible 
research team that takes minimal risks and is capable of conducting complex research protocols with Veteran 
populations, while always adhering to Good Clinical Practice standards. Drs. Niles and Mori will be in regular 
communication with each other and with the Co-Investigators regarding project decisions. Conflicts will be 
resolved through group consensus with the team. 
Approval through the VA Boston and Boston Medical Center/Boston University Medical Campus Institutional 
Review Boards will be obtained prior to recruiting or consenting any participants.   
 
To ensure participant safety, once participants are enrolled in the study, study staff will immediately report all 
adverse and serious adverse events to one of the PIs. The PI will, per standardized procedures, report them to 
the IRB for their review.  
 
Any SAE, whether related to study intervention or not, will be reported within the required 5-day reporting 
period to the IRB and will be followed by an additional letter detailing the nature of the SAE. In the event that a 
participant either withdraws from the study or the PIs decide to discontinue a participant due to a SAE, the 
participant will be monitored by the investigators until (a) a resolution is reached (e.g., the problem has 
resolved or stabilized with no further change expected), (b) the SAE is determined to be clearly unrelated to 
the study intervention, or (c) the SAE results in death. Outcomes of SAEs will be regularly reported to the IRB.  
8.0 
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