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Novel Interventions for GWVI

Novel Interventions for Gulf War Veterans' Illnesses

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02661997
Acronym
NIGWVI
Enrollment
114
Registered
2016-01-25
Start date
2017-06-01
Completion date
2025-09-30
Last updated
2025-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gulf War Veteran's Illness

Keywords

Tai Chi, Wellness, Mind-body, Gulf War Illness, Gulf War Veteran's Illness, GWVI

Brief summary

The primary aim of this study was to examine the beneficial effects of two novel treatments for Gulf War Veteran's Illness (Tai Chi and Wellness intervention) and to establish the efficacy of these mind-body approaches to symptom reduction. In March 2020 after 53 Veterans were randomized, this trial was halted due to the onset of COVID-19. In late 2020, we shifted from conducting an in-person study to a fully remote study with interventions delivered via synchronous video teleconferencing. We then randomized an additional 61 Veterans for a study grand total of 114 Veterans.

Detailed description

Objectives: Over 40,000 Veterans who served in the 1991 Gulf War (GW) have a persistent form of chronic multisymptom illness that defines Gulf War Veterans Illness (GWVI). With no existing proven treatments to provide relief to these sufferers, it is critical to find efficacious and acceptable treatments for GWVI. The long-term goal was to develop a safe, readily available, mind-body treatment to reduce pain and other chronic symptoms and enhance wellness in Veterans with GWVI. Tai Chi is a traditional Chinese mind-body therapy that has been practiced for centuries. In the last decade, the investigators have demonstrated that Tai Chi can improve both physical health and psychological wellbeing in patients with a variety of chronic conditions. This randomized trial aimed to establish the effectiveness of a Tai Chi mind-body treatment in Veterans with GWVI. One hundred and fourteen participants meeting criteria for GWVI were randomly assigned to either a Tai Chi exercise or a wellness education group for 12 weeks with a post treatment assessment, and follow-up assessments. The investigators addressed the following Specific Aims: Specific Aim 1: Evaluate whether the Tai Chi intervention will reduce symptoms of pain in Veterans with GWVI more than the Wellness intervention. The investigators hypothesized that participants randomized to the Tai Chi intervention will show a greater reduction in pain symptoms than those in the Wellness intervention and will maintain changes over a 9-month follow-up period. Specific Aim 2: Evaluate whether the Tai Chi intervention improves fatigue, cognition, quality of life, and physical functioning in GW Veterans with GWVI, as compared to the Wellness intervention. The investigators hypothesized that participants randomized to the Tai Chi intervention will evidence more improvement in fatigue, cognitive functioning, quality of life, and physical functioning than those randomized to the Wellness intervention and will maintain changes over a 9-month follow-up period. Research Design: One hundred and fourteen GW Veterans meeting criteria for GWVI were randomly assigned to either the Tai Chi Condition (n=58) or the Wellness Condition (n=56). Methodology: Participants received 12 weeks of the randomly-assigned intervention twice each week. Assessments were conducted at baseline, 12 weeks (post-intervention), 24 weeks (3 months post-intervention) and 48 weeks (9 months post-intervention). Assessments included instruments to measure self-reported pain, fatigue, cognition, quality of life, and physical functioning.

Interventions

All components of the program derive from the classical Yang Tai Chi 108 postures, which has been shown to be a moderate intensity exercise. Each Tai Chi session will last 60 minutes, twice a week for 12 weeks. In the first session, the Tai Chi instructors will explain exercise theory and procedures of Tai Chi. In subsequent sessions, subjects will practice Tai Chi under the instruction of one of the Tai Chi instructors. Every session will include the following components: (1) warm up and a review of Tai Chi principles; (2) meditation with Tai Chi movement; (3) breathing techniques; and (4) relaxation. The investigators will instruct patients to practice at least 30 minutes a day at home throughout the intervention period and will provide them with training materials for home practice.

The investigators will utilize a wellness education program for the control group because this approach has been successfully used in other Tai Chi studies from the investigators' team. Participants in the Wellness condition will also attend two 60-minute sessions per week for 12 weeks. The Wellness condition will correspond to the VA Whole Health Program to emphasize wellness across various domains (e.g., physical, emotional, and spiritual lives.) Each session will include a video clip as well as a brief mindfulness exercise that corresponds with the material being presented. The project coordinator for this study will provide the didactic lessons.

Sponsors

Boston University
CollaboratorOTHER
Tufts Medical Center
CollaboratorOTHER
VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Served in the 1991 Gulf War. * Meets criteria for chronic multisymptom illness (CMI) based on CDC criteria32 characterized by one or more symptoms of at least 6 months duration from at least two of three symptom categories: 1) musculoskeletal pain (muscle pain, joint pain, or stiffness); 2) fatigue; and 3) mood-cognition. * One symptom of CMI must be musculoskeletal or joint pain or stiffness of at least 6 months duration (in addition to fatigue or cognitive complaints of the CDC criteria32). * Not planning to relocate in next 3 months * English-Speaking: English is the only language to be used during the exercise training program. Our self-reported outcome measures are obtained from validated English-version questionnaires. In addition, using other languages would likely require separate classes, recruitment and instructors which are beyond our current study scope. * Has access to a home computer or device that will allow telehealth delivery of the intervention.

Exclusion criteria

* Lacks the capacity to provide consent * Major medical, psychiatric, or neurological disorder or has a moderate or severe traumatic brain injury, which could 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, mindfulness, or yoga practice, defined as at least three hours per week for more than three months. * Veterans with prior experience who do not currently engage in regular practice at this level will be eligible * Reports difficulty standing on feet for the majority of a Tai Chi class (approximately 60 minutes). * Participants who are disruptive or disrespectful or engage in behavior that threatens staff and/or participant safety may be terminated from the study. * Participants who are currently involved in another treatment study that might confound our findings (e.g., treatments for GWI, pain).

Design outcomes

Primary

MeasureTime frameDescription
Change in Brief Pain Inventory - Short Form (BPI) - Pain InterferenceChange from baseline to post-treatment at 12 weeksThe Brief Pain Inventory (BPI) is a self-report measure that examines pain severity and interference with functioning in various life domains, including general activity, mood, walking activity, work, relationships, sleep, and enjoyment of life. In addition, the BPI asks questions about pain relief, pain quality, and patient perception of the cause of pain. It has been used and validated in a wide range of clinical conditions and is a gold standard measure for the assessment of pain and its impact. Test-retest reliability has been studied in a variety of pain populations and ranges from .83 to .98. Results of the Pain Interference subscale are reported below. Each item of the 7-item subscale is rated from 0 to 10 with higher scores reflecting a worse outcome. Sum scores are changed to mean scores so they are in the same metric as the individual items constituting the scale with a minimum score of 0 and a maximum score of 10.
Change in Brief Pain Inventory - Short Form (BPI) - Pain SeverityChange from baseline to post-treatment at 12 weeksThe Brief Pain Inventory (BPI) is a self-report measure that examines pain severity and interference with functioning in various life domains, including general activity, mood, walking activity, work, relationships, sleep, and enjoyment of life. In addition, the BPI asks questions about pain relief, pain quality, and patient perception of the cause of pain. It has been used and validated in a wide range of clinical conditions and is a gold standard measure for the assessment of pain and its impact. Test-retest reliability has been studied in a variety of pain populations and ranges from .83 to .98. Results of the Pain Severity subscale are reported below. Each item of the 4-item subscale is rated from 0 to 10 with higher scores reflecting a worse outcome. Sum scores are changed to mean scores so they are in the same metric as the individual items constituting the scale with a minimum score of 0 and a maximum score of 10.

Secondary

MeasureTime frameDescription
50 Foot Walk TestChange from baseline to post-treatment (12 weeks)The Walk 50FT is a widely used timed measure of fast walking speed. It involves a participant walking 50 feet without any use of an aid while study staff monitor and record their time in seconds using a stopwatch. Participants are instructed to walk as fast as possible. Two trials of the Walk 50FT were conducted and an average score of these two trials was produced. A lower Walk 50FT score is indicative of higher (i.e., faster) walking speed. The Walk 50FT is empirically supported, possesses strong validity and reliability, and demonstrates sensitivity to change over time among individuals with chronic disorders and is a promising measure of physical functioning in patients with a pain-related condition.
Change in Trail Making Test (TMT) - Trails AChange from baseline to post-treatment at 12 weeksThe Trail Making Test (TMT) is one of the most popular neuropsychological tests and provides information on visual search, scanning, speed of processing, mental flexibility, and executive functioning. It consists of two parts: A and B. Part A requires an individual to draw lines sequentially connecting 25 encircled numbers distributed on a sheet of paper. Task B requires a similar task, however a participant is asked to draw a line alternating between numbers and letters (e.g., 1, A, 2, B, 3, C, etc). The score on each part represents the amount of time required to complete the task with higher scores reflecting a worse outcome. Results from Trails A are presented below.
Change in Trail Making Test (TMT) - Trails BChange from baseline to post-treatment at 12 weeksThe Trail Making Test (TMT) is one of the most popular neuropsychological tests and provides information on visual search, scanning, speed of processing, mental flexibility, and executive functioning. It consists of two parts: A and B. Trails A requires an individual to draw lines sequentially connecting 25 encircled numbers distributed on a sheet of paper. Trails B requires a similar task, however a participant is asked to draw a line alternating between numbers and letters (e.g., 1, A, 2, B, 3, C, etc). The score on each part represents the amount of time required to complete the task with higher scores reflecting a worse outcome. Results from Trails B is reported below.
Change in Hopkins Verbal Learning Test - Revised (HVLT-R)Change from baseline to post-treatment at 12 weeksThe Hopkins Verbal Learning Test- Revised (HVLT-R) is a cognitive test of verbal learning and memory task where participants are instructed to learn a list of 12 nouns over three learning trials. Each time study staff read the list of words, participants are asked to recall as many words from the list as they can remember immediately afterwards. The sum of correctly recalled words over the three trials is a measure of total recall. Scores can range from 0 to 36 with higher scores reflect better a better outcome.
Change in Multi-dimensional Fatigue Inventory (MFI-20)Change from baseline to post-treatment at 12 weeksThe Multidimensional Fatigue Inventory (MFI-20) is a widely-used self-report measure that quantifies symptoms of fatigue, including general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. Internal consistency and test-retest reliability are strong for all subscales. Responses are made on a 5-point scale from 1-5, with higher scores reflecting greater fatigue. Sum scores are changed to mean scores so they are in the same metric as the individual items constituting the scale with a minimum score of 1 and a maximum score of 5. Results from the General Fatigue Subscale are provided below.
Short Physical Performance Battery (SPPB) - 4-Meter Walk TestChange from baseline to post-treatment at 12 weeksThe Short Physical Performance Battery (SPPB) captures domains of strength, endurance, and balance and is highly predictive of disability. The SPPB is based on three timed measures of standing balance, walking (gait) speed, and ability to rise from a chair. The 4-Meter Walk Test is a measure of gate speed where participants are asked to walk 4-meters at a normal walking pace while being timed. Results from the 4-Meter Walk Test are presented below.
Short Physical Performance Battery (SPPB) - Chair Stand Test (CST)Change from baseline to post-treatment at 12 weeksThe Short Physical Performance Battery (SPPB) captures domains of strength, endurance, and balance and is highly predictive of disability. The SPPB consists of three timed measures: standing balance, walking speed, and ability to rise from a chair. The Chair Sit Test (CST) is a timed evaluation of the strength and power of lower-extremities. Participants are instructed to complete five chair stands from a sitting position with their arms folded across their chests. They are instructed to do this as fast as possible, while being timed. Lower scores reflect a better outcome.
Short Physical Performance Battery (SPPB) - Standing Balance Test (SBT)Change from baseline to post-treatment at 12 weeksThe SPPB captures domains of strength, endurance, and balance and is highly predictive of disability. The SPPB consists of three timed measures: standing balance, walking speed, and ability to rise from a chair. The Standing Balance Test measures ability to balance while holding in three different positions for 10 seconds. For each position they are able to hold for 10 seconds, they receive a score of 1. If they are unable to hold the position, they receive a score of 0. To illustrate the minimal variability on this measure, results are provided below for the tandem position (the most difficult position to hold).
PROMIS Global Health Scale - Mental Health SubscaleChange from baseline to post-treatment at 12 weeksThe PROMIS initiative developed new ways to measure patient-reported outcomes such as pain, fatigue, physical functioning, emotional distress, and social role participation that have a major impact on quality-of-life across a variety of chronic diseases. The PROMIS Global Health Scale asks participants to rate their health in terms of physical health, mental health, and satisfaction with social activities, and two scores are produced: Physical Health and Mental Health. Results from the Mental Health Subscale are presented below. Sum scores are changed to mean scores so they are in the same metric as the individual items constituting the scale with a minimum score of 1 and a maximum score of 5. Higher scores reflect a better outcome.
PROMIS Global Health Scale - Physical Health SubscaleChange from baseline to post-treatment at 12 weeksThe PROMIS initiative developed new ways to measure patient-reported outcomes such as pain, fatigue, physical functioning, emotional distress, and social role participation that have a major impact on quality-of-life across a variety of chronic diseases. The PROMIS Global Health Scale asks participants to rate their health in terms of physical health, mental health, and satisfaction with social activities, and two scores are produced: Physical Health and Mental Health. Results from the Physical Health Subscale are presented below. Sum scores are changed to mean scores so they are in the same metric as the individual items constituting the scale with a minimum score of 1 and a maximum score of 5. Higher scores reflect a better outcome.

Other

MeasureTime frameDescription
Change in Chronic Pain Self-Efficacy Scale (CPSS)Change from baseline CPSS at 12 weeksThe Chronic Pain Self-Efficacy Scale (CPSS) is a 22-item questionnaire designed to measure chronic pain patients' perceived self-efficacy to cope with the consequences of chronic pain. Questions are broken down into three categories: self-efficacy for pain management, self-efficacy for physical function, and self-efficacy for coping with symptoms. Each item in the CPSS is presented as a question (e.g., How certain are you that you can decrease your pain quite a bit?). Participants rate each belief on a 10-point Likert scale (range 10-100). A total score is calculated by first summing the item responses across all three categories. Sum scores are changed to mean scores so they are in the same metric as the individual items constituting the scale with a minimum score of 10 and a maximum score of 100, with higher scores reflecting greater perceived self-efficacy.
Group Cohesiveness Scale (GSC)Post-treatment measure taken at 12 weeksThe Group Cohesiveness Scale is a self-report measure that examines group cohesion within a therapeutic environment. Each of the 7 questions are responded to on a 5-point scale (1-5). Scores are obtained by summing the items with higher scores reflecting greater group cohesiveness.
PROMIS Self-Efficacy for Managing SymptomsChange from baseline PROMIS Self-Efficacy at 12 weeksThe Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Symptoms is an 8-item self-report measure that examines elements of self-care. Each item is responded to on a 5 point scale ranging from 1-5. Raw scores are calculated by summing responses to all the items (score range 8-40), and then converted to a T-score using a conversion table located in the administration guide provided for the PROMIS instruments. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. Higher scores reflect greater confidence in one's ability to manage one's symptoms
Mindfulness Attention Awareness Scale (MAAS)Change from baseline MAAS at 12 weeksThe Mindfulness Attention Awareness Scale (MAAS) is a 15-item self-report measure that assesses participants' openness towards, awareness of, and attention to the present. This scale can reveal information about one's self-regulation and well-being. Each item is responded to on a 6-point scale from 1 (almost always) to 6 (almost never) with higher scores reflecting greater mindfulness awareness. Sum scores are changed to mean scores so they are in the same metric as the individual items constituting the scale with a minimum score of 1 and a maximum score of 6.
Body Mass Index (BMI)Change from baseline measurements at 12 weeksStudy staff recorded participants' height in inches and weight in pounds. Weight and height measurements were used to calculate Body Mass Index using the formula: \[weight (lb) / height (in)\^2\] x 703. This data is only available for the participants who participated in-person.
Systolic Blood PressureChange from baseline measurements at 12 weeksSystolic pressures were measured in mmHg using a blood pressure cuff and sphygmomanometer. Two blood pressure readings were taken at each assessment point, and the average was used. This data is only available for the participants who were in-person.
Health Symptom Checklist (HSC)Change from baseline HSC at 12 weeksThe Health Symptom Checklist consists of 34 frequently reported health and mental health symptoms from nine body systems (cardiac, pulmonary, dermatological, gastrointestinal, genitourinary, musculoskeletal, neurological, neuropsychological and psychological). On a 5 point scale from 0 (no) to 4 (very often), respondents indicate if they have experienced each symptom in the last 30 days, and if yes, how often. A response of 2 (about once per week) or greater is considered an endorsement of the symptom. All symptoms endorsed are added together for a total score. Total scores can range from 0 to 34 with higher scores indicating more symptoms.
Physical Activity Recall (PAR) - General Physical ActivityChange from baseline PAR at 12 weeksThe Physical Activity Recall (PAR) is a measure that was administered by study staff in an interview format. The PAR asks participants' to report time they spent engaged in general physical activity, strength building activities, and activities that involve flexibility over the past week. For the measure of general physical activity, all activity that is of at least moderate intensity is counted and is reported as hours of activity in the past week.
Physical Activity Recall (PAR) - Strength ActivityChange from baseline PAR Strength time at 12 weeksThe Physical Activity Recall (PAR) is a measure that was administered by study staff in an interview format. The PAR asks participants' to report time they spent engaged in general physical activity, strength building activities, and activities that involve flexibility over the past week. For the measure of strength activity, time spent engaged in strength building activity over the past seven days is totaled and is reported as hours of strength activity in the past week.
Physical Activity Recall (PAR) - Flexibility ActivityChange from baseline PAR Flexibility time at 12 weeksThe Physical Activity Recall (PAR) is a measure that was administered by study staff in an interview format. The PAR asks participants' to report time they spent engaged in general physical activity, strength building activities, and activities that involve flexibility over the past week. For the measure of flexibility activity, time spent engaged in activity that involve flexibility over the past seven days is totaled and is reported as hours of flexibility activity in the past week.
The Epidemic - Pandemic Impacts Inventory (EPII) - Negative ImpactsChange from baseline EPII at 12 weeksThe Epidemic - Pandemic Impacts Inventory (EPII) is a 92-item questionnaire. This recently-developed measure was designed to learn about and describe the impact of the coronavirus disease pandemic on various domains of personal and family life, including employment, education, home life, social life, economic, physical health, infection experiences, and positive changes. This instrument was only administered to the remote participants, after the pandemic started. Participants were asked to respond to each item with one of the following four responses: 1) Yes, me, 2) Yes, person in home, 3) no, and 4) not applicable. Any yes response was coded as 1 and a no or not applicable response was coded as 0. Two scales were created (Positive Impacts and Negative Impacts) by summing the items for each scale. Negative Impacts are reported here (possible response range of 0-73), with higher scores indicating greater negative impact of the pandemic.
The Epidemic - Pandemic Impacts Inventory (EPII) - Positive ImpactsChange from baseline EPII at 12 weeks Change from baseline EPII at 12-weeksThe Epidemic - Pandemic Impacts Inventory (EPII) is a 92-item questionnaire. This recently-developed measure was designed to learn about and describe the impact of the coronavirus disease pandemic on various domains of personal and family life, including employment, education, home life, social life, economic, physical health, infection experiences, and positive changes. This instrument was only administered to the remote participants, after the pandemic started. Participants were asked to respond to each item with one of the following four responses: 1) Yes, me, 2) Yes, person in home, 3) no, and 4) not applicable. Any yes response was coded as 1 and a no or not applicable response was coded as 0. Two scales were created (Positive Impacts and Negative Impacts) by summing the items for each scale. Positive Impacts are reported here (possible response range of 0-18), with higher scores indicating greater positive impact of the pandemic.
Diastolic Blood PressureChange from baseline measurements at 12-weeksDiastolic pressures were measured in mmHg using a blood pressure cuff and sphygmomanometer. Two blood pressure readings were taken at each assessment point, and the average was used. This data is only available for the participants who were in-person.
The PTSD Checklist for DSM-5 (PCL-5)Change from baseline PCL-5 at 12 weeksThe PTSD Checklist for DSM-5 (PCL-5) is a self-report measure consisting of 20 items that parallel the DSM-5 posttraumatic stress disorder criteria. Respondents indicate on a 5-point scale (0-4) how much they have been bothered in the last month by particular symptoms that are related to stressful military experiences. Sum scores are changed to mean scores so they are in the same metric as the individual items constituting the scale with a minimum score of 0 and a maximum score of 4.The DSM-IV version of the PCL has been shown to have excellent reliability and validity.
Insomnia Severity Index (ISI)Change from baseline ISI at 12 weeksThe Insomnia Severity Index (ISI) is a brief instrument that was designed to assess the severity of both nighttime and daytime components of insomnia. It is comprised of seven questions that are responded to on a scale from 0 to 4.. Sum scores are changed to mean scores so they are in the same metric as the individual items constituting the scale with a minimum score of 0 and a maximum score of 4, with higher scores reflecting greater insomnia symptom severity.
Participant Compliance Log - Intervention Sessions Attended12 weeksStudy staff will monitor number of intervention sessions attended. The maximum total number of sessions is 24 (range 0-24) with higher numbers showing greater number of sessions attended.
Participant Compliance Log - Assessment Sessions Attended12 weeksPercentage of participants who completed the post-treatment assessment.
Weekly Practice Log Sheet12 weeksThis measure will monitor compliance with home Tai Chi practice during the intervention. Average Tai Chi practice minutes per week is reported.
Client Satisfaction QuestionnaireDifference between two intervention groups at post-treatment (12 weeks)The Client Satisfaction Questionnaire (CSQ) is is an 8-item measure that assesses satisfaction with both the interventions. Each item is responded to on a 4-point scale (1-4) and items are summed for a total score that can range from 8-32 with higher scores reflecting greater satisfaction.
Depression Anxiety Sensitivity Scale (DASS) - Depression ScaleChange from baseline DASS at 12 weeksThe Depression Anxiety Sensitivity Scale (DASS) is a 21 item questionnaire that is responded to on a 4-point scale that ranges from 0-3. There are three self-report scales designed to measure the negative emotional states of depression, anxiety and stress. Scores are obtained by summing the items that comprise each of the three scales, with higher scores reflecting greater symptomatology. Sum scores are changed to mean scores so they are in the same metric as the individual items constituting the scale with a minimum score of 0 and a maximum score of 3.The DASS was constructed not merely as another set of scales to measure conventionally defined emotional states, but to further the process of defining, understanding, and measuring the ubiquitous and clinically significant emotional states usually described as depression, anxiety and stress.
Depression Anxiety Sensitivity Scale (DASS) - Anxiety ScaleChange from baseline DASS at 12 weeksThe Depression Anxiety Sensitivity Scale (DASS) is a 21 item questionnaire that is responded to on a 4-point scale that ranges from 0-3. There are three self-report scales designed to measure the negative emotional states of depression, anxiety and stress. Scores are obtained by summing the items that comprise each of the three scales, with higher scores reflecting greater symptomatology. Sum scores are changed to mean scores so they are in the same metric as the individual items constituting the scale with a minimum score of 0 and a maximum score of 3.The DASS was constructed not merely as another set of scales to measure conventionally defined emotional states, but to further the process of defining, understanding, and measuring the ubiquitous and clinically significant emotional states usually described as depression, anxiety and stress.
Depression Anxiety Sensitivity Scale (DASS) - Stress ScaleChange from baseline DASS at 12 weeksThe Depression Anxiety Sensitivity Scale (DASS) is a 21 item questionnaire that is responded to on a 4-point scale that ranges from 0-3. There are three self-report scales designed to measure the negative emotional states of depression, anxiety and stress. Scores are obtained by summing the items that comprise each of the three scales, with higher scores reflecting greater symptomatology. Sum scores are changed to mean scores so they are in the same metric as the individual items constituting the scale with a minimum score of 0 and a maximum score of 3.The DASS was constructed not merely as another set of scales to measure conventionally defined emotional states, but to further the process of defining, understanding, and measuring the ubiquitous and clinically significant emotional states usually described as depression, anxiety and stress.
Change in the Pain Catastrophizing Scale (PCS)Change from baseline PCS at 12 weeksThe PCS is a 13-item self-report scale that assesses the degree to which people engage in three subtypes of pain catastrophizing: rumination, magnification, and helplessness. Each item is responded to on a 5 point scale (0-4). Sum scores are changed to mean scores so they are in the same metric as the individual items constituting the scale with a minimum score of 0 and a maximum score of 4, with higher scores reflecting greater pain catastrophizing. It is one of the most widely used instruments for measuring catastrophic thinking in relation to pain.
Change in West Haven-Yale Multidimensional Pain Inventory (WHYMPI) - General Activity ScaleChange from baseline WHYMPI at 12 weeksThe West Haven-Yale Multidimensional Pain Inventory (WHMPI) is a well-validated measure of the experience of chronic pain and has been shown to be applicable across a variety of clinical pain conditions. The 52-item inventory is divided into three parts: 1) Important dimensions of the chronic pain experience, 2) patient perceptions of how important others respond to their pain, and 3) engagement in everyday activities. Patient's responses to WHYMPI items are made on a 7-point scale (0-6). The focus of the analysis reported before is on the 18 items that constitute Part 3. This General Activity Scale was scored by summing responses and then obtaining an average by dividing by the number of non-missing items. Total average scores range from 0-6 with higher scores reflecting greater engagement in common everyday activities.

Countries

United States

Participant flow

Participants by arm

ArmCount
Tai Chi Intervention
All components of the program derive from the classical Yang Tai Chi 108 postures, which has been shown to be a moderate intensity exercise. Each Tai Chi session will last 60 minutes, twice a week for 12 weeks. In the first session, the Tai Chi instructors will explain exercise theory and procedures of Tai Chi. In subsequent sessions, subjects will practice Tai Chi under the instruction of one of the Tai Chi instructors. Every session will include the following components: (1) warm up and a review of Tai Chi principles; (2) meditation with Tai Chi movement; (3) breathing techniques; and (4) relaxation. The investigators will instruct patients to practice at least 30 minutes a day at home throughout the intervention period and will provide them with training materials for home practice.
58
Wellness Intervention
The investigators will utilize a wellness education program for the control group because this approach has been successfully used in other Tai Chi studies from the investigators' team. Participants in the Wellness condition will also attend two 60-minute sessions per week for 12 weeks. The Wellness condition will correspond to the VA Whole Health Program to emphasize wellness across various domains (e.g., physical, emotional, and spiritual lives.) Each session will include a video clip as well as a brief mindfulness exercise that corresponds with the material being presented. The project coordinator for this study will provide the didactic lessons.
56
Total114

Baseline characteristics

CharacteristicTai Chi InterventionTotalWellness Intervention
Age, Continuous57.09 years
STANDARD_DEVIATION 8.4
56.80 years
STANDARD_DEVIATION 7.9
56.50 years
STANDARD_DEVIATION 7.41
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
6 Participants24 Participants18 Participants
Race (NIH/OMB)
More than one race
6 Participants9 Participants3 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants5 Participants4 Participants
Race (NIH/OMB)
White
45 Participants76 Participants31 Participants
Region of Enrollment
United States
58 Participants114 Participants56 Participants
Sex: Female, Male
Female
10 Participants20 Participants10 Participants
Sex: Female, Male
Male
48 Participants94 Participants46 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
1 / 580 / 56
other
Total, other adverse events
3 / 582 / 56
serious
Total, serious adverse events
0 / 582 / 56

Outcome results

Primary

Change in Brief Pain Inventory - Short Form (BPI) - Pain Interference

The Brief Pain Inventory (BPI) is a self-report measure that examines pain severity and interference with functioning in various life domains, including general activity, mood, walking activity, work, relationships, sleep, and enjoyment of life. In addition, the BPI asks questions about pain relief, pain quality, and patient perception of the cause of pain. It has been used and validated in a wide range of clinical conditions and is a gold standard measure for the assessment of pain and its impact. Test-retest reliability has been studied in a variety of pain populations and ranges from .83 to .98. Results of the Pain Interference subscale are reported below. Each item of the 7-item subscale is rated from 0 to 10 with higher scores reflecting a worse outcome. Sum scores are changed to mean scores so they are in the same metric as the individual items constituting the scale with a minimum score of 0 and a maximum score of 10.

Time frame: Change from baseline to post-treatment at 12 weeks

Population: 98 Veterans participated in the post-treatment assessment, however only 91 completed full data on this measure.

ArmMeasureGroupValue (MEAN)Dispersion
Tai Chi InterventionChange in Brief Pain Inventory - Short Form (BPI) - Pain InterferenceBaseline Measure4.47 score on a scaleStandard Deviation 2.69
Tai Chi InterventionChange in Brief Pain Inventory - Short Form (BPI) - Pain InterferencePost-Treatment (12 weeks)3.59 score on a scaleStandard Deviation 2.92
Wellness InterventionChange in Brief Pain Inventory - Short Form (BPI) - Pain InterferenceBaseline Measure4.77 score on a scaleStandard Deviation 2.85
Wellness InterventionChange in Brief Pain Inventory - Short Form (BPI) - Pain InterferencePost-Treatment (12 weeks)3.66 score on a scaleStandard Deviation 2.62
p-value: 0.58ANOVA
Primary

Change in Brief Pain Inventory - Short Form (BPI) - Pain Severity

The Brief Pain Inventory (BPI) is a self-report measure that examines pain severity and interference with functioning in various life domains, including general activity, mood, walking activity, work, relationships, sleep, and enjoyment of life. In addition, the BPI asks questions about pain relief, pain quality, and patient perception of the cause of pain. It has been used and validated in a wide range of clinical conditions and is a gold standard measure for the assessment of pain and its impact. Test-retest reliability has been studied in a variety of pain populations and ranges from .83 to .98. Results of the Pain Severity subscale are reported below. Each item of the 4-item subscale is rated from 0 to 10 with higher scores reflecting a worse outcome. Sum scores are changed to mean scores so they are in the same metric as the individual items constituting the scale with a minimum score of 0 and a maximum score of 10.

Time frame: Change from baseline to post-treatment at 12 weeks

Population: 98 Veterans participated in the post-treatment assessment, however only 91 completed full data on this measure.

ArmMeasureGroupValue (MEAN)Dispersion
Tai Chi InterventionChange in Brief Pain Inventory - Short Form (BPI) - Pain SeverityBaseline Measure4.28 score on a scaleStandard Deviation 1.94
Tai Chi InterventionChange in Brief Pain Inventory - Short Form (BPI) - Pain SeverityPost-Treatment (12 weeks)4.02 score on a scaleStandard Deviation 2.51
Wellness InterventionChange in Brief Pain Inventory - Short Form (BPI) - Pain SeverityBaseline Measure4.75 score on a scaleStandard Deviation 2.38
Wellness InterventionChange in Brief Pain Inventory - Short Form (BPI) - Pain SeverityPost-Treatment (12 weeks)4.43 score on a scaleStandard Deviation 2.46
p-value: 0.88ANOVA
Secondary

50 Foot Walk Test

The Walk 50FT is a widely used timed measure of fast walking speed. It involves a participant walking 50 feet without any use of an aid while study staff monitor and record their time in seconds using a stopwatch. Participants are instructed to walk as fast as possible. Two trials of the Walk 50FT were conducted and an average score of these two trials was produced. A lower Walk 50FT score is indicative of higher (i.e., faster) walking speed. The Walk 50FT is empirically supported, possesses strong validity and reliability, and demonstrates sensitivity to change over time among individuals with chronic disorders and is a promising measure of physical functioning in patients with a pain-related condition.

Time frame: Change from baseline to post-treatment (12 weeks)

Population: 98 Veterans participated in the post-treatment assessment, however only 42 completed full data on this measure. This measure could not be administered when the study changed to be a fully remote study during the pandemic.

ArmMeasureGroupValue (MEAN)Dispersion
Tai Chi Intervention50 Foot Walk TestBaseline measure10.72 secondsStandard Deviation 2.26
Tai Chi Intervention50 Foot Walk TestPost-treatment (12-weeks)11.27 secondsStandard Deviation 4.04
Wellness Intervention50 Foot Walk TestBaseline measure10.55 secondsStandard Deviation 3.96
Wellness Intervention50 Foot Walk TestPost-treatment (12-weeks)9.64 secondsStandard Deviation 2.74
p-value: 0.032ANOVA
Secondary

Change in Hopkins Verbal Learning Test - Revised (HVLT-R)

The Hopkins Verbal Learning Test- Revised (HVLT-R) is a cognitive test of verbal learning and memory task where participants are instructed to learn a list of 12 nouns over three learning trials. Each time study staff read the list of words, participants are asked to recall as many words from the list as they can remember immediately afterwards. The sum of correctly recalled words over the three trials is a measure of total recall. Scores can range from 0 to 36 with higher scores reflect better a better outcome.

Time frame: Change from baseline to post-treatment at 12 weeks

Population: 98 Veterans participated in the post-treatment assessment, however only 42 completed full data on this measure. This measure could not be administered when the study changed to be a fully remote study during the pandemic.

ArmMeasureGroupValue (MEAN)Dispersion
Tai Chi InterventionChange in Hopkins Verbal Learning Test - Revised (HVLT-R)Baseline measure22.25 total words recalledStandard Deviation 4.32
Tai Chi InterventionChange in Hopkins Verbal Learning Test - Revised (HVLT-R)Post-treatment (12-weeks)23.85 total words recalledStandard Deviation 3.91
Wellness InterventionChange in Hopkins Verbal Learning Test - Revised (HVLT-R)Baseline measure21.27 total words recalledStandard Deviation 4.1
Wellness InterventionChange in Hopkins Verbal Learning Test - Revised (HVLT-R)Post-treatment (12-weeks)22.59 total words recalledStandard Deviation 4.71
p-value: 0.36ANOVA
Secondary

Change in Multi-dimensional Fatigue Inventory (MFI-20)

The Multidimensional Fatigue Inventory (MFI-20) is a widely-used self-report measure that quantifies symptoms of fatigue, including general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. Internal consistency and test-retest reliability are strong for all subscales. Responses are made on a 5-point scale from 1-5, with higher scores reflecting greater fatigue. Sum scores are changed to mean scores so they are in the same metric as the individual items constituting the scale with a minimum score of 1 and a maximum score of 5. Results from the General Fatigue Subscale are provided below.

Time frame: Change from baseline to post-treatment at 12 weeks

Population: 98 Veterans participated in the post-treatment assessment, however only 91 completed full data on this measure.

ArmMeasureGroupValue (MEAN)Dispersion
Tai Chi InterventionChange in Multi-dimensional Fatigue Inventory (MFI-20)Post-Treatment (12 weeks)3.55 score on a scaleStandard Deviation 1.06
Tai Chi InterventionChange in Multi-dimensional Fatigue Inventory (MFI-20)Baseline Measure3.62 score on a scaleStandard Deviation 1.04
Wellness InterventionChange in Multi-dimensional Fatigue Inventory (MFI-20)Baseline Measure3.72 score on a scaleStandard Deviation 0.91
Wellness InterventionChange in Multi-dimensional Fatigue Inventory (MFI-20)Post-Treatment (12 weeks)3.42 score on a scaleStandard Deviation 0.93
p-value: 0.17ANOVA
Secondary

Change in Trail Making Test (TMT) - Trails A

The Trail Making Test (TMT) is one of the most popular neuropsychological tests and provides information on visual search, scanning, speed of processing, mental flexibility, and executive functioning. It consists of two parts: A and B. Part A requires an individual to draw lines sequentially connecting 25 encircled numbers distributed on a sheet of paper. Task B requires a similar task, however a participant is asked to draw a line alternating between numbers and letters (e.g., 1, A, 2, B, 3, C, etc). The score on each part represents the amount of time required to complete the task with higher scores reflecting a worse outcome. Results from Trails A are presented below.

Time frame: Change from baseline to post-treatment at 12 weeks

Population: 98 Veterans participated in the post-treatment assessment, however only 42 completed full data on this measure. This measure could not be administered when the study changed to be a fully remote study during the pandemic.

ArmMeasureGroupValue (MEAN)Dispersion
Tai Chi InterventionChange in Trail Making Test (TMT) - Trails ABaseline measure25.28 secondsStandard Deviation 8.67
Tai Chi InterventionChange in Trail Making Test (TMT) - Trails APost-treatment (12-weeks)24.75 secondsStandard Deviation 8.83
Wellness InterventionChange in Trail Making Test (TMT) - Trails ABaseline measure27.96 secondsStandard Deviation 9.34
Wellness InterventionChange in Trail Making Test (TMT) - Trails APost-treatment (12-weeks)26.29 secondsStandard Deviation 10.63
p-value: 0.44ANOVA
Secondary

Change in Trail Making Test (TMT) - Trails B

The Trail Making Test (TMT) is one of the most popular neuropsychological tests and provides information on visual search, scanning, speed of processing, mental flexibility, and executive functioning. It consists of two parts: A and B. Trails A requires an individual to draw lines sequentially connecting 25 encircled numbers distributed on a sheet of paper. Trails B requires a similar task, however a participant is asked to draw a line alternating between numbers and letters (e.g., 1, A, 2, B, 3, C, etc). The score on each part represents the amount of time required to complete the task with higher scores reflecting a worse outcome. Results from Trails B is reported below.

Time frame: Change from baseline to post-treatment at 12 weeks

Population: 98 Veterans participated in the post-treatment assessment, however only 40 completed full data on this measure. This measure could not be administered when the study changed to be a fully remote study during the pandemic.

ArmMeasureGroupValue (MEAN)Dispersion
Tai Chi InterventionChange in Trail Making Test (TMT) - Trails BBaseline measure65.91 secondsStandard Deviation 30.25
Tai Chi InterventionChange in Trail Making Test (TMT) - Trails BPost-treatment (12-weeks)66.04 secondsStandard Deviation 42.6
Wellness InterventionChange in Trail Making Test (TMT) - Trails BBaseline measure63.52 secondsStandard Deviation 24.21
Wellness InterventionChange in Trail Making Test (TMT) - Trails BPost-treatment (12-weeks)60.52 secondsStandard Deviation 24.16
p-value: 0.73ANOVA
Secondary

PROMIS Global Health Scale - Mental Health Subscale

The PROMIS initiative developed new ways to measure patient-reported outcomes such as pain, fatigue, physical functioning, emotional distress, and social role participation that have a major impact on quality-of-life across a variety of chronic diseases. The PROMIS Global Health Scale asks participants to rate their health in terms of physical health, mental health, and satisfaction with social activities, and two scores are produced: Physical Health and Mental Health. Results from the Mental Health Subscale are presented below. Sum scores are changed to mean scores so they are in the same metric as the individual items constituting the scale with a minimum score of 1 and a maximum score of 5. Higher scores reflect a better outcome.

Time frame: Change from baseline to post-treatment at 12 weeks

Population: 98 Veterans participated in the post-treatment assessment, however only 92 completed full data on this measure.

ArmMeasureGroupValue (MEAN)Dispersion
Tai Chi InterventionPROMIS Global Health Scale - Mental Health SubscalePost-treatment Measure (12-weeks)2.73 units on a scaleStandard Deviation 1.11
Tai Chi InterventionPROMIS Global Health Scale - Mental Health SubscaleBaseline Measure2.44 units on a scaleStandard Deviation 0.93
Wellness InterventionPROMIS Global Health Scale - Mental Health SubscaleBaseline Measure2.67 units on a scaleStandard Deviation 0.84
Wellness InterventionPROMIS Global Health Scale - Mental Health SubscalePost-treatment Measure (12-weeks)2.83 units on a scaleStandard Deviation 0.82
p-value: 0.24ANOVA
Secondary

PROMIS Global Health Scale - Physical Health Subscale

The PROMIS initiative developed new ways to measure patient-reported outcomes such as pain, fatigue, physical functioning, emotional distress, and social role participation that have a major impact on quality-of-life across a variety of chronic diseases. The PROMIS Global Health Scale asks participants to rate their health in terms of physical health, mental health, and satisfaction with social activities, and two scores are produced: Physical Health and Mental Health. Results from the Physical Health Subscale are presented below. Sum scores are changed to mean scores so they are in the same metric as the individual items constituting the scale with a minimum score of 1 and a maximum score of 5. Higher scores reflect a better outcome.

Time frame: Change from baseline to post-treatment at 12 weeks

Population: 98 Veterans participated in the post-treatment assessment, however only 92 completed full data on this measure.

ArmMeasureGroupValue (MEAN)Dispersion
Tai Chi InterventionPROMIS Global Health Scale - Physical Health SubscaleBaseline Measure2.88 score on a scaleStandard Deviation 0.7
Tai Chi InterventionPROMIS Global Health Scale - Physical Health SubscalePost-Treatment (12 weeks)3.00 score on a scaleStandard Deviation 0.8
Wellness InterventionPROMIS Global Health Scale - Physical Health SubscaleBaseline Measure2.93 score on a scaleStandard Deviation 0.74
Wellness InterventionPROMIS Global Health Scale - Physical Health SubscalePost-Treatment (12 weeks)3.02 score on a scaleStandard Deviation 0.74
Comparison: This is an analysis of pre to post-treatment changes on the Physical Health subscale of the PROMIS Global Health Scalep-value: 0.88ANOVA
Secondary

Short Physical Performance Battery (SPPB) - 4-Meter Walk Test

The Short Physical Performance Battery (SPPB) captures domains of strength, endurance, and balance and is highly predictive of disability. The SPPB is based on three timed measures of standing balance, walking (gait) speed, and ability to rise from a chair. The 4-Meter Walk Test is a measure of gate speed where participants are asked to walk 4-meters at a normal walking pace while being timed. Results from the 4-Meter Walk Test are presented below.

Time frame: Change from baseline to post-treatment at 12 weeks

Population: 98 Veterans participated in the post-treatment assessment, however only 42 completed full data on this measure. This measure could not be administered when the study changed to be a fully remote study during the pandemic.

ArmMeasureGroupValue (MEAN)Dispersion
Tai Chi InterventionShort Physical Performance Battery (SPPB) - 4-Meter Walk TestBaseline measure5.26 secondsStandard Deviation 1.14
Tai Chi InterventionShort Physical Performance Battery (SPPB) - 4-Meter Walk TestPost-treatment (12-weeks)5.23 secondsStandard Deviation 1.19
Wellness InterventionShort Physical Performance Battery (SPPB) - 4-Meter Walk TestBaseline measure5.54 secondsStandard Deviation 0.92
Wellness InterventionShort Physical Performance Battery (SPPB) - 4-Meter Walk TestPost-treatment (12-weeks)4.70 secondsStandard Deviation 1.02
p-value: 0.006ANOVA
Secondary

Short Physical Performance Battery (SPPB) - Chair Stand Test (CST)

The Short Physical Performance Battery (SPPB) captures domains of strength, endurance, and balance and is highly predictive of disability. The SPPB consists of three timed measures: standing balance, walking speed, and ability to rise from a chair. The Chair Sit Test (CST) is a timed evaluation of the strength and power of lower-extremities. Participants are instructed to complete five chair stands from a sitting position with their arms folded across their chests. They are instructed to do this as fast as possible, while being timed. Lower scores reflect a better outcome.

Time frame: Change from baseline to post-treatment at 12 weeks

Population: 98 Veterans participated in the post-treatment assessment, however only 39 completed full data on this measure. This measure could not be administered when the study changed to be a fully remote study during the pandemic.

ArmMeasureGroupValue (MEAN)Dispersion
Tai Chi InterventionShort Physical Performance Battery (SPPB) - Chair Stand Test (CST)Baseline measure13.60 secondsStandard Deviation 3.13
Tai Chi InterventionShort Physical Performance Battery (SPPB) - Chair Stand Test (CST)Post-treatment (12-weeks)13.92 secondsStandard Deviation 5.03
Wellness InterventionShort Physical Performance Battery (SPPB) - Chair Stand Test (CST)Baseline measure12.49 secondsStandard Deviation 3.39
Wellness InterventionShort Physical Performance Battery (SPPB) - Chair Stand Test (CST)Post-treatment (12-weeks)13.20 secondsStandard Deviation 7.94
p-value: 0.55ANOVA
Secondary

Short Physical Performance Battery (SPPB) - Standing Balance Test (SBT)

The SPPB captures domains of strength, endurance, and balance and is highly predictive of disability. The SPPB consists of three timed measures: standing balance, walking speed, and ability to rise from a chair. The Standing Balance Test measures ability to balance while holding in three different positions for 10 seconds. For each position they are able to hold for 10 seconds, they receive a score of 1. If they are unable to hold the position, they receive a score of 0. To illustrate the minimal variability on this measure, results are provided below for the tandem position (the most difficult position to hold).

Time frame: Change from baseline to post-treatment at 12 weeks

Population: 98 Veterans participated in the post-treatment assessment, however only 41 completed full data on this measure. This measure could not be administered when the study changed to be a fully remote study during the pandemic.

ArmMeasureGroupValue (MEAN)Dispersion
Tai Chi InterventionShort Physical Performance Battery (SPPB) - Standing Balance Test (SBT)Baseline measure1.0 units on a scaleStandard Deviation 0
Tai Chi InterventionShort Physical Performance Battery (SPPB) - Standing Balance Test (SBT)Post-treatment (12-weeks)1.0 units on a scaleStandard Deviation 0
Wellness InterventionShort Physical Performance Battery (SPPB) - Standing Balance Test (SBT)Baseline measure1.0 units on a scaleStandard Deviation 0
Wellness InterventionShort Physical Performance Battery (SPPB) - Standing Balance Test (SBT)Post-treatment (12-weeks).95 units on a scaleStandard Deviation 0.21
p-value: 0.36ANOVA
Other Pre-specified

Body Mass Index (BMI)

Study staff recorded participants' height in inches and weight in pounds. Weight and height measurements were used to calculate Body Mass Index using the formula: \[weight (lb) / height (in)\^2\] x 703. This data is only available for the participants who participated in-person.

Time frame: Change from baseline measurements at 12 weeks

Population: 42 Veterans participated in the in-person post-treatment assessment and all 42 completed full data on this measure.

ArmMeasureGroupValue (MEAN)Dispersion
Tai Chi InterventionBody Mass Index (BMI)Baseline Measure31.23 kg/m^2Standard Deviation 6.03
Tai Chi InterventionBody Mass Index (BMI)Post-treatment31.43 kg/m^2Standard Deviation 5.95
Wellness InterventionBody Mass Index (BMI)Baseline Measure31.43 kg/m^2Standard Deviation 4.9
Wellness InterventionBody Mass Index (BMI)Post-treatment31.87 kg/m^2Standard Deviation 4.18
p-value: 0.67ANOVA
Other Pre-specified

Change in Chronic Pain Self-Efficacy Scale (CPSS)

The Chronic Pain Self-Efficacy Scale (CPSS) is a 22-item questionnaire designed to measure chronic pain patients' perceived self-efficacy to cope with the consequences of chronic pain. Questions are broken down into three categories: self-efficacy for pain management, self-efficacy for physical function, and self-efficacy for coping with symptoms. Each item in the CPSS is presented as a question (e.g., How certain are you that you can decrease your pain quite a bit?). Participants rate each belief on a 10-point Likert scale (range 10-100). A total score is calculated by first summing the item responses across all three categories. Sum scores are changed to mean scores so they are in the same metric as the individual items constituting the scale with a minimum score of 10 and a maximum score of 100, with higher scores reflecting greater perceived self-efficacy.

Time frame: Change from baseline CPSS at 12 weeks

Population: 98 Veterans participated in the post-treatment assessment, however only 91 completed full data on this measure.

ArmMeasureGroupValue (MEAN)Dispersion
Tai Chi InterventionChange in Chronic Pain Self-Efficacy Scale (CPSS)Baseline Measure61.09 units on a scaleStandard Deviation 18.6
Tai Chi InterventionChange in Chronic Pain Self-Efficacy Scale (CPSS)Post-treatment63.02 units on a scaleStandard Deviation 18.81
Wellness InterventionChange in Chronic Pain Self-Efficacy Scale (CPSS)Baseline Measure57.25 units on a scaleStandard Deviation 18.45
Wellness InterventionChange in Chronic Pain Self-Efficacy Scale (CPSS)Post-treatment61.52 units on a scaleStandard Deviation 19.94
p-value: 0.44ANOVA
Other Pre-specified

Change in the Pain Catastrophizing Scale (PCS)

The PCS is a 13-item self-report scale that assesses the degree to which people engage in three subtypes of pain catastrophizing: rumination, magnification, and helplessness. Each item is responded to on a 5 point scale (0-4). Sum scores are changed to mean scores so they are in the same metric as the individual items constituting the scale with a minimum score of 0 and a maximum score of 4, with higher scores reflecting greater pain catastrophizing. It is one of the most widely used instruments for measuring catastrophic thinking in relation to pain.

Time frame: Change from baseline PCS at 12 weeks

Population: 98 Veterans participated in the post-treatment assessment, however only 89 completed full data on this measure.

ArmMeasureGroupValue (MEAN)Dispersion
Tai Chi InterventionChange in the Pain Catastrophizing Scale (PCS)Baseline Measure1.61 units on a scaleStandard Deviation 1.1
Tai Chi InterventionChange in the Pain Catastrophizing Scale (PCS)Post-treatment1.43 units on a scaleStandard Deviation 0.99
Wellness InterventionChange in the Pain Catastrophizing Scale (PCS)Baseline Measure1.49 units on a scaleStandard Deviation 1.16
Wellness InterventionChange in the Pain Catastrophizing Scale (PCS)Post-treatment1.31 units on a scaleStandard Deviation 1.05
p-value: 0.99ANOVA
Other Pre-specified

Change in West Haven-Yale Multidimensional Pain Inventory (WHYMPI) - General Activity Scale

The West Haven-Yale Multidimensional Pain Inventory (WHMPI) is a well-validated measure of the experience of chronic pain and has been shown to be applicable across a variety of clinical pain conditions. The 52-item inventory is divided into three parts: 1) Important dimensions of the chronic pain experience, 2) patient perceptions of how important others respond to their pain, and 3) engagement in everyday activities. Patient's responses to WHYMPI items are made on a 7-point scale (0-6). The focus of the analysis reported before is on the 18 items that constitute Part 3. This General Activity Scale was scored by summing responses and then obtaining an average by dividing by the number of non-missing items. Total average scores range from 0-6 with higher scores reflecting greater engagement in common everyday activities.

Time frame: Change from baseline WHYMPI at 12 weeks

Population: 98 Veterans participated in the post-treatment assessment, however only 91 completed full data on this measure.

ArmMeasureGroupValue (MEAN)Dispersion
Tai Chi InterventionChange in West Haven-Yale Multidimensional Pain Inventory (WHYMPI) - General Activity ScaleBaseline Measure2.84 units on a scaleStandard Deviation 1.06
Tai Chi InterventionChange in West Haven-Yale Multidimensional Pain Inventory (WHYMPI) - General Activity ScalePost-treatment2.76 units on a scaleStandard Deviation 1
Wellness InterventionChange in West Haven-Yale Multidimensional Pain Inventory (WHYMPI) - General Activity ScaleBaseline Measure2.58 units on a scaleStandard Deviation 0.94
Wellness InterventionChange in West Haven-Yale Multidimensional Pain Inventory (WHYMPI) - General Activity ScalePost-treatment2.80 units on a scaleStandard Deviation 1.07
p-value: 0.09ANOVA
Other Pre-specified

Client Satisfaction Questionnaire

The Client Satisfaction Questionnaire (CSQ) is is an 8-item measure that assesses satisfaction with both the interventions. Each item is responded to on a 4-point scale (1-4) and items are summed for a total score that can range from 8-32 with higher scores reflecting greater satisfaction.

Time frame: Difference between two intervention groups at post-treatment (12 weeks)

Population: 98 Veterans participated in the post-treatment assessment, however only 87 completed full data on this measure.

ArmMeasureValue (MEAN)Dispersion
Tai Chi InterventionClient Satisfaction Questionnaire28.81 units on a scaleStandard Deviation 3.64
Wellness InterventionClient Satisfaction Questionnaire27.67 units on a scaleStandard Deviation 3.74
p-value: 0.15t-test, 2 sided
Other Pre-specified

Depression Anxiety Sensitivity Scale (DASS) - Anxiety Scale

The Depression Anxiety Sensitivity Scale (DASS) is a 21 item questionnaire that is responded to on a 4-point scale that ranges from 0-3. There are three self-report scales designed to measure the negative emotional states of depression, anxiety and stress. Scores are obtained by summing the items that comprise each of the three scales, with higher scores reflecting greater symptomatology. Sum scores are changed to mean scores so they are in the same metric as the individual items constituting the scale with a minimum score of 0 and a maximum score of 3.The DASS was constructed not merely as another set of scales to measure conventionally defined emotional states, but to further the process of defining, understanding, and measuring the ubiquitous and clinically significant emotional states usually described as depression, anxiety and stress.

Time frame: Change from baseline DASS at 12 weeks

Population: 98 Veterans participated in the post-treatment assessment, however only 92 completed full data on this measure.

ArmMeasureGroupValue (MEAN)Dispersion
Tai Chi InterventionDepression Anxiety Sensitivity Scale (DASS) - Anxiety ScaleBaseline Measure0.95 units on a scaleStandard Deviation 0.73
Tai Chi InterventionDepression Anxiety Sensitivity Scale (DASS) - Anxiety ScalePost-treatment0.85 units on a scaleStandard Deviation 0.75
Wellness InterventionDepression Anxiety Sensitivity Scale (DASS) - Anxiety ScaleBaseline Measure0.86 units on a scaleStandard Deviation 0.66
Wellness InterventionDepression Anxiety Sensitivity Scale (DASS) - Anxiety ScalePost-treatment0.69 units on a scaleStandard Deviation 0.62
p-value: 0.42ANOVA
Other Pre-specified

Depression Anxiety Sensitivity Scale (DASS) - Depression Scale

The Depression Anxiety Sensitivity Scale (DASS) is a 21 item questionnaire that is responded to on a 4-point scale that ranges from 0-3. There are three self-report scales designed to measure the negative emotional states of depression, anxiety and stress. Scores are obtained by summing the items that comprise each of the three scales, with higher scores reflecting greater symptomatology. Sum scores are changed to mean scores so they are in the same metric as the individual items constituting the scale with a minimum score of 0 and a maximum score of 3.The DASS was constructed not merely as another set of scales to measure conventionally defined emotional states, but to further the process of defining, understanding, and measuring the ubiquitous and clinically significant emotional states usually described as depression, anxiety and stress.

Time frame: Change from baseline DASS at 12 weeks

Population: 98 Veterans participated in the post-treatment assessment, however only 92 completed full data on this measure.

ArmMeasureGroupValue (MEAN)Dispersion
Tai Chi InterventionDepression Anxiety Sensitivity Scale (DASS) - Depression ScaleBaseline Measure1.18 units on a scaleStandard Deviation 0.9
Tai Chi InterventionDepression Anxiety Sensitivity Scale (DASS) - Depression ScalePost-treatment0.95 units on a scaleStandard Deviation 0.97
Wellness InterventionDepression Anxiety Sensitivity Scale (DASS) - Depression ScaleBaseline Measure1.03 units on a scaleStandard Deviation 0.87
Wellness InterventionDepression Anxiety Sensitivity Scale (DASS) - Depression ScalePost-treatment0.82 units on a scaleStandard Deviation 0.74
p-value: 0.91ANOVA
Other Pre-specified

Depression Anxiety Sensitivity Scale (DASS) - Stress Scale

The Depression Anxiety Sensitivity Scale (DASS) is a 21 item questionnaire that is responded to on a 4-point scale that ranges from 0-3. There are three self-report scales designed to measure the negative emotional states of depression, anxiety and stress. Scores are obtained by summing the items that comprise each of the three scales, with higher scores reflecting greater symptomatology. Sum scores are changed to mean scores so they are in the same metric as the individual items constituting the scale with a minimum score of 0 and a maximum score of 3.The DASS was constructed not merely as another set of scales to measure conventionally defined emotional states, but to further the process of defining, understanding, and measuring the ubiquitous and clinically significant emotional states usually described as depression, anxiety and stress.

Time frame: Change from baseline DASS at 12 weeks

Population: 98 Veterans participated in the post-treatment assessment, however only 92 completed full data on this measure.

ArmMeasureGroupValue (MEAN)Dispersion
Tai Chi InterventionDepression Anxiety Sensitivity Scale (DASS) - Stress ScaleBaseline Measure1.21 units on a scaleStandard Deviation 0.73
Tai Chi InterventionDepression Anxiety Sensitivity Scale (DASS) - Stress ScalePost-treatment1.14 units on a scaleStandard Deviation 0.81
Wellness InterventionDepression Anxiety Sensitivity Scale (DASS) - Stress ScaleBaseline Measure1.36 units on a scaleStandard Deviation 0.69
Wellness InterventionDepression Anxiety Sensitivity Scale (DASS) - Stress ScalePost-treatment1.12 units on a scaleStandard Deviation 0.7
p-value: 0.1ANOVA
Other Pre-specified

Diastolic Blood Pressure

Diastolic pressures were measured in mmHg using a blood pressure cuff and sphygmomanometer. Two blood pressure readings were taken at each assessment point, and the average was used. This data is only available for the participants who were in-person.

Time frame: Change from baseline measurements at 12-weeks

Population: 42 Veterans participated in this in-person post-treatment assessment and data is available for all 42.

ArmMeasureGroupValue (MEAN)Dispersion
Tai Chi InterventionDiastolic Blood PressureBaseline Measure84.70 millimeters of mercuryStandard Deviation 10.79
Tai Chi InterventionDiastolic Blood PressurePost-treatment82.66 millimeters of mercuryStandard Deviation 7.75
Wellness InterventionDiastolic Blood PressureBaseline Measure86.33 millimeters of mercuryStandard Deviation 9.66
Wellness InterventionDiastolic Blood PressurePost-treatment85.23 millimeters of mercuryStandard Deviation 11.81
p-value: 0.8ANOVA
Other Pre-specified

Group Cohesiveness Scale (GSC)

The Group Cohesiveness Scale is a self-report measure that examines group cohesion within a therapeutic environment. Each of the 7 questions are responded to on a 5-point scale (1-5). Scores are obtained by summing the items with higher scores reflecting greater group cohesiveness.

Time frame: Post-treatment measure taken at 12 weeks

Population: 72 Veterans participated in this week 12 assessment.

ArmMeasureValue (MEAN)Dispersion
Tai Chi InterventionGroup Cohesiveness Scale (GSC)28.12 units on a scaleStandard Deviation 6.47
Wellness InterventionGroup Cohesiveness Scale (GSC)30.49 units on a scaleStandard Deviation 4.67
p-value: 0.09t-test, 2 sided
Other Pre-specified

Health Symptom Checklist (HSC)

The Health Symptom Checklist consists of 34 frequently reported health and mental health symptoms from nine body systems (cardiac, pulmonary, dermatological, gastrointestinal, genitourinary, musculoskeletal, neurological, neuropsychological and psychological). On a 5 point scale from 0 (no) to 4 (very often), respondents indicate if they have experienced each symptom in the last 30 days, and if yes, how often. A response of 2 (about once per week) or greater is considered an endorsement of the symptom. All symptoms endorsed are added together for a total score. Total scores can range from 0 to 34 with higher scores indicating more symptoms.

Time frame: Change from baseline HSC at 12 weeks

Population: 98 Veterans participated in the post-treatment assessment, however only 91 completed full data on this measure.

ArmMeasureGroupValue (MEAN)Dispersion
Tai Chi InterventionHealth Symptom Checklist (HSC)Post-treatment18.07 score on a scaleStandard Deviation 8.37
Tai Chi InterventionHealth Symptom Checklist (HSC)Baseline Measure18.82 score on a scaleStandard Deviation 7.87
Wellness InterventionHealth Symptom Checklist (HSC)Baseline Measure17.53 score on a scaleStandard Deviation 8.35
Wellness InterventionHealth Symptom Checklist (HSC)Post-treatment15.27 score on a scaleStandard Deviation 8.38
p-value: 0.13ANOVA
Other Pre-specified

Insomnia Severity Index (ISI)

The Insomnia Severity Index (ISI) is a brief instrument that was designed to assess the severity of both nighttime and daytime components of insomnia. It is comprised of seven questions that are responded to on a scale from 0 to 4.. Sum scores are changed to mean scores so they are in the same metric as the individual items constituting the scale with a minimum score of 0 and a maximum score of 4, with higher scores reflecting greater insomnia symptom severity.

Time frame: Change from baseline ISI at 12 weeks

Population: 98 Veterans participated in the post-treatment assessment, however only 86 completed full data on this measure.

ArmMeasureValue (MEAN)Dispersion
Tai Chi InterventionInsomnia Severity Index (ISI)2.40 units on a scaleStandard Deviation 1.11
Wellness InterventionInsomnia Severity Index (ISI)2.38 units on a scaleStandard Deviation 0.9
p-value: 0.04ANOVA
Other Pre-specified

Mindfulness Attention Awareness Scale (MAAS)

The Mindfulness Attention Awareness Scale (MAAS) is a 15-item self-report measure that assesses participants' openness towards, awareness of, and attention to the present. This scale can reveal information about one's self-regulation and well-being. Each item is responded to on a 6-point scale from 1 (almost always) to 6 (almost never) with higher scores reflecting greater mindfulness awareness. Sum scores are changed to mean scores so they are in the same metric as the individual items constituting the scale with a minimum score of 1 and a maximum score of 6.

Time frame: Change from baseline MAAS at 12 weeks

Population: 98 Veterans participated in the post-treatment assessment, however only 91 completed full data on this measure.

ArmMeasureGroupValue (MEAN)Dispersion
Tai Chi InterventionMindfulness Attention Awareness Scale (MAAS)Baseline Measure3.85 units on a scaleStandard Deviation 1.16
Tai Chi InterventionMindfulness Attention Awareness Scale (MAAS)Post-treatment3.99 units on a scaleStandard Deviation 1.24
Wellness InterventionMindfulness Attention Awareness Scale (MAAS)Baseline Measure3.91 units on a scaleStandard Deviation 1.05
Wellness InterventionMindfulness Attention Awareness Scale (MAAS)Post-treatment4.18 units on a scaleStandard Deviation 1.12
p-value: 0.44ANOVA
Other Pre-specified

Participant Compliance Log - Assessment Sessions Attended

Percentage of participants who completed the post-treatment assessment.

Time frame: 12 weeks

Population: This data was collected on all 114 participants who were validly randomized for this study.

ArmMeasureValue (NUMBER)
Tai Chi InterventionParticipant Compliance Log - Assessment Sessions Attended82.8 percentage of participants
Wellness InterventionParticipant Compliance Log - Assessment Sessions Attended89.3 percentage of participants
Other Pre-specified

Participant Compliance Log - Intervention Sessions Attended

Study staff will monitor number of intervention sessions attended. The maximum total number of sessions is 24 (range 0-24) with higher numbers showing greater number of sessions attended.

Time frame: 12 weeks

Population: This data was collected on all 114 participants who were validly randomized for this study.

ArmMeasureValue (MEAN)Dispersion
Tai Chi InterventionParticipant Compliance Log - Intervention Sessions Attended15.62 sessions attendedStandard Deviation 7.33
Wellness InterventionParticipant Compliance Log - Intervention Sessions Attended16.95 sessions attendedStandard Deviation 7.62
p-value: 0.35t-test, 2 sided
Other Pre-specified

Physical Activity Recall (PAR) - Flexibility Activity

The Physical Activity Recall (PAR) is a measure that was administered by study staff in an interview format. The PAR asks participants' to report time they spent engaged in general physical activity, strength building activities, and activities that involve flexibility over the past week. For the measure of flexibility activity, time spent engaged in activity that involve flexibility over the past seven days is totaled and is reported as hours of flexibility activity in the past week.

Time frame: Change from baseline PAR Flexibility time at 12 weeks

Population: 98 Veterans participated in the post-treatment assessment, however only 95 completed full data on this measure.

ArmMeasureGroupValue (MEAN)Dispersion
Tai Chi InterventionPhysical Activity Recall (PAR) - Flexibility ActivityBaseline Measure0.52 Hours of activity per weekStandard Deviation 0.81
Tai Chi InterventionPhysical Activity Recall (PAR) - Flexibility ActivityPost-treatment1.75 Hours of activity per weekStandard Deviation 1.86
Wellness InterventionPhysical Activity Recall (PAR) - Flexibility ActivityBaseline Measure0.57 Hours of activity per weekStandard Deviation 0.94
Wellness InterventionPhysical Activity Recall (PAR) - Flexibility ActivityPost-treatment0.46 Hours of activity per weekStandard Deviation 0.77
p-value: <0.001ANOVA
Other Pre-specified

Physical Activity Recall (PAR) - General Physical Activity

The Physical Activity Recall (PAR) is a measure that was administered by study staff in an interview format. The PAR asks participants' to report time they spent engaged in general physical activity, strength building activities, and activities that involve flexibility over the past week. For the measure of general physical activity, all activity that is of at least moderate intensity is counted and is reported as hours of activity in the past week.

Time frame: Change from baseline PAR at 12 weeks

Population: 98 Veterans participated in the post-treatment assessment, however only 95 completed full data on this measure.

ArmMeasureGroupValue (MEAN)Dispersion
Tai Chi InterventionPhysical Activity Recall (PAR) - General Physical ActivityBaseline Measure9.05 hours per weekStandard Deviation 10.34
Tai Chi InterventionPhysical Activity Recall (PAR) - General Physical ActivityPost-treatment9.66 hours per weekStandard Deviation 10.95
Wellness InterventionPhysical Activity Recall (PAR) - General Physical ActivityBaseline Measure10.55 hours per weekStandard Deviation 9.82
Wellness InterventionPhysical Activity Recall (PAR) - General Physical ActivityPost-treatment9.11 hours per weekStandard Deviation 9.14
p-value: 0.31ANOVA
Other Pre-specified

Physical Activity Recall (PAR) - Strength Activity

The Physical Activity Recall (PAR) is a measure that was administered by study staff in an interview format. The PAR asks participants' to report time they spent engaged in general physical activity, strength building activities, and activities that involve flexibility over the past week. For the measure of strength activity, time spent engaged in strength building activity over the past seven days is totaled and is reported as hours of strength activity in the past week.

Time frame: Change from baseline PAR Strength time at 12 weeks

Population: 98 Veterans participated in the post-treatment assessment, however only 95 completed full data on this measure.

ArmMeasureGroupValue (MEAN)Dispersion
Tai Chi InterventionPhysical Activity Recall (PAR) - Strength ActivityBaseline Measure0.40 hours of activity per weekStandard Deviation 0.89
Tai Chi InterventionPhysical Activity Recall (PAR) - Strength ActivityPost-treatment0.55 hours of activity per weekStandard Deviation 1.13
Wellness InterventionPhysical Activity Recall (PAR) - Strength ActivityBaseline Measure1.04 hours of activity per weekStandard Deviation 3.95
Wellness InterventionPhysical Activity Recall (PAR) - Strength ActivityPost-treatment0.32 hours of activity per weekStandard Deviation 0.89
p-value: 0.16ANOVA
Other Pre-specified

PROMIS Self-Efficacy for Managing Symptoms

The Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Symptoms is an 8-item self-report measure that examines elements of self-care. Each item is responded to on a 5 point scale ranging from 1-5. Raw scores are calculated by summing responses to all the items (score range 8-40), and then converted to a T-score using a conversion table located in the administration guide provided for the PROMIS instruments. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. Higher scores reflect greater confidence in one's ability to manage one's symptoms

Time frame: Change from baseline PROMIS Self-Efficacy at 12 weeks

Population: 98 Veterans participated in the post-treatment assessment, however only 92 completed full data on this measure.

ArmMeasureGroupValue (MEAN)Dispersion
Tai Chi InterventionPROMIS Self-Efficacy for Managing SymptomsBaseline Measure45.75 units on a scaleStandard Deviation 9.66
Tai Chi InterventionPROMIS Self-Efficacy for Managing SymptomsPost-treatment46.51 units on a scaleStandard Deviation 9.76
Wellness InterventionPROMIS Self-Efficacy for Managing SymptomsBaseline Measure45.71 units on a scaleStandard Deviation 8.08
Wellness InterventionPROMIS Self-Efficacy for Managing SymptomsPost-treatment46.00 units on a scaleStandard Deviation 7.7
p-value: 0.75ANOVA
Other Pre-specified

Systolic Blood Pressure

Systolic pressures were measured in mmHg using a blood pressure cuff and sphygmomanometer. Two blood pressure readings were taken at each assessment point, and the average was used. This data is only available for the participants who were in-person.

Time frame: Change from baseline measurements at 12 weeks

Population: 42 Veterans participated in the in-person post-treatment assessment and data for all 42 is available on this measure.

ArmMeasureGroupValue (MEAN)Dispersion
Tai Chi InterventionSystolic Blood PressureBaseline Measure127.07 millimeters of mercuryStandard Deviation 16.05
Tai Chi InterventionSystolic Blood PressurePost-treatment125.49 millimeters of mercuryStandard Deviation 15.18
Wellness InterventionSystolic Blood PressureBaseline Measure126.64 millimeters of mercuryStandard Deviation 11.41
Wellness InterventionSystolic Blood PressurePost-treatment128.92 millimeters of mercuryStandard Deviation 13.57
p-value: 0.43ANOVA
Other Pre-specified

The Epidemic - Pandemic Impacts Inventory (EPII) - Negative Impacts

The Epidemic - Pandemic Impacts Inventory (EPII) is a 92-item questionnaire. This recently-developed measure was designed to learn about and describe the impact of the coronavirus disease pandemic on various domains of personal and family life, including employment, education, home life, social life, economic, physical health, infection experiences, and positive changes. This instrument was only administered to the remote participants, after the pandemic started. Participants were asked to respond to each item with one of the following four responses: 1) Yes, me, 2) Yes, person in home, 3) no, and 4) not applicable. Any yes response was coded as 1 and a no or not applicable response was coded as 0. Two scales were created (Positive Impacts and Negative Impacts) by summing the items for each scale. Negative Impacts are reported here (possible response range of 0-73), with higher scores indicating greater negative impact of the pandemic.

Time frame: Change from baseline EPII at 12 weeks

Population: 98 Veterans participated in the post-treatment assessment, however only 50 completed full data on this measure.

ArmMeasureGroupValue (MEAN)Dispersion
Tai Chi InterventionThe Epidemic - Pandemic Impacts Inventory (EPII) - Negative ImpactsBaseline Measure17.25 units on a scaleStandard Deviation 10.66
Tai Chi InterventionThe Epidemic - Pandemic Impacts Inventory (EPII) - Negative ImpactsPost-treatment16.95 units on a scaleStandard Deviation 10.61
Wellness InterventionThe Epidemic - Pandemic Impacts Inventory (EPII) - Negative ImpactsBaseline Measure18.58 units on a scaleStandard Deviation 8.83
Wellness InterventionThe Epidemic - Pandemic Impacts Inventory (EPII) - Negative ImpactsPost-treatment17.29 units on a scaleStandard Deviation 8.21
p-value: 0.56ANOVA
Other Pre-specified

The Epidemic - Pandemic Impacts Inventory (EPII) - Positive Impacts

The Epidemic - Pandemic Impacts Inventory (EPII) is a 92-item questionnaire. This recently-developed measure was designed to learn about and describe the impact of the coronavirus disease pandemic on various domains of personal and family life, including employment, education, home life, social life, economic, physical health, infection experiences, and positive changes. This instrument was only administered to the remote participants, after the pandemic started. Participants were asked to respond to each item with one of the following four responses: 1) Yes, me, 2) Yes, person in home, 3) no, and 4) not applicable. Any yes response was coded as 1 and a no or not applicable response was coded as 0. Two scales were created (Positive Impacts and Negative Impacts) by summing the items for each scale. Positive Impacts are reported here (possible response range of 0-18), with higher scores indicating greater positive impact of the pandemic.

Time frame: Change from baseline EPII at 12 weeks Change from baseline EPII at 12-weeks

Population: 98 Veterans participated in the post-treatment assessment, however only 50 completed full data on this measure.

ArmMeasureGroupValue (MEAN)Dispersion
Tai Chi InterventionThe Epidemic - Pandemic Impacts Inventory (EPII) - Positive ImpactsPost-treatment6.04 units on a scaleStandard Deviation 5.01
Tai Chi InterventionThe Epidemic - Pandemic Impacts Inventory (EPII) - Positive ImpactsBaseline Measure5.05 units on a scaleStandard Deviation 3.53
Wellness InterventionThe Epidemic - Pandemic Impacts Inventory (EPII) - Positive ImpactsBaseline Measure7.38 units on a scaleStandard Deviation 4.6
Wellness InterventionThe Epidemic - Pandemic Impacts Inventory (EPII) - Positive ImpactsPost-treatment8.83 units on a scaleStandard Deviation 4.87
p-value: 0.64ANOVA
Other Pre-specified

The PTSD Checklist for DSM-5 (PCL-5)

The PTSD Checklist for DSM-5 (PCL-5) is a self-report measure consisting of 20 items that parallel the DSM-5 posttraumatic stress disorder criteria. Respondents indicate on a 5-point scale (0-4) how much they have been bothered in the last month by particular symptoms that are related to stressful military experiences. Sum scores are changed to mean scores so they are in the same metric as the individual items constituting the scale with a minimum score of 0 and a maximum score of 4.The DSM-IV version of the PCL has been shown to have excellent reliability and validity.

Time frame: Change from baseline PCL-5 at 12 weeks

Population: 98 Veterans participated in the post-treatment assessment, however only 91 completed full data on this measure.

ArmMeasureGroupValue (MEAN)Dispersion
Tai Chi InterventionThe PTSD Checklist for DSM-5 (PCL-5)Baseline Measure1.85 units on a scaleStandard Deviation 1.04
Tai Chi InterventionThe PTSD Checklist for DSM-5 (PCL-5)Post-treatment1.72 units on a scaleStandard Deviation 1.01
Wellness InterventionThe PTSD Checklist for DSM-5 (PCL-5)Baseline Measure1.86 units on a scaleStandard Deviation 1.02
Wellness InterventionThe PTSD Checklist for DSM-5 (PCL-5)Post-treatment1.60 units on a scaleStandard Deviation 0.96
p-value: 0.26ANOVA
Other Pre-specified

Weekly Practice Log Sheet

This measure will monitor compliance with home Tai Chi practice during the intervention. Average Tai Chi practice minutes per week is reported.

Time frame: 12 weeks

Population: 58 Veterans were randomized to Tai Chi, however only 54 completed full data on this measure.

ArmMeasureValue (MEAN)Dispersion
Tai Chi InterventionWeekly Practice Log Sheet183.62 minutes per weekStandard Deviation 87.7

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026