PTSDNCT05693805
Feasibility of Remote Tai Chi
A study testing Tai Chi and Wellness program in people with PTSD and Pain, Chronic, run by Boston University at 1 site in United States.
Trial summary
In the proposed trial, the investigators plan to refine interventions, then conduct a small randomized trial to provide critical information to inform a future large-scale randomized efficacy trial of Tai Chi for Post Traumatic Stress Disorder (PTSD) and chronic pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD, Pain, Chronic
- What is being tested?
- Tai Chi and Wellness program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2023to 28 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veteran status as indicated by self-report
- PTSD Case Definition. Veterans who meet Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (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 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). The investigators will facilitate enrollment for Veterans not currently enrolled but wish to take part in the study.
Who cannot join
- 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 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Boston Healthcare System
Boston, Massachusetts, 02130
About this study
Official title: Feasibility of Remote-Delivery Interventions: Tai Chi and Wellness for PTSD and Pain in Veterans
In the proposed trial, the investigators plan to refine interventions, then conduct a small randomized trial to provide critical information to inform a future large-scale randomized efficacy trial of Tai Chi for Post Traumatic Stress Disorder (PTSD) and chronic pain. Building on the combined experience the proposed study will progress in new directions to:
- 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'.
- Determine the feasibility and acceptability of a remotely delivered randomized trial of these two interventions and the assessment protocols during Phase Two.
- 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.
- Conditions
- PTSD, Pain, Chronic
- Being tested
- Tai Chi, Wellness program
- Keywords
- Tai Chi, PTSD, Chronic musculoskeletal pain, Veterans
- Medical subject headings
- Stress Disorders, Post-Traumatic, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai ChiBehavioural
The remote delivery Tai Chi protocol that will be developed in this study for Veterans with PTSD and pain will be adapted from a protocol that has been well-tested in previous trials All components of the program derive from the classical Yang-style Tai Chi 108 postures, which has been shown to be a moderate intensity exercise. Sessions will last 60 minutes, twice a week for 12 weeks. Experienced instructors will follow the Tai Chi protocol with rigorous quality control procedures. We will provide the patients with printed materials on the Tai Chi program, including Tai Chi principles, practice techniques, and safety precautions. Every session will include: warm up and a review of Tai Chi principles; breathing techniques; meditation with Tai Chi movement; and relaxation.
Wellness programBehavioural
The Wellness intervention that will be developed for this study will consist of 60-minute sessions that meet twice a week for 12 weeks, and will be facilitated by doctoral level psychology staff and/or psychology trainees who will be supervised by staff. 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. Using the SMART goals model, participants will set health and wellness goals each week. Discussions about ways to address potential barriers will be included in this condition.
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi Group | Experimental | Participants randomized to this arm will receive a standardized Tai Chi protocol developed for veterans, adapted by the investigators, and administered by experienced VA Tai Chi instructors. Receives: Behavioral: Tai Chi |
| Wellness Group | Active comparator | Participants randomized to this arm will receive a wellness program that has been successfully used by the investigators in other studies of veterans with chronic pain. Receives: Behavioral: Wellness program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Satisfaction Post Treatment With Interventions Being Tested
Assessed by the self-administered Client Satisfaction Questionnaire (CSQ), an 8-item scale with individual responses ranging from 1 to 4. Higher scores are associated with greater satisfaction with the treatment.
Measured: Post-treatment (about 12 weeks)
Percentage of Participants Satisfaction at Follow-up With Interventions Being Tested
Percentage of participants that have a mean CSQ item-score of 3 or greater on the 1-4 scale of the 8 original items at post-treatment.
Measured: Post-treatment (about 12 weeks)
Number of Participants That Attended at Least 70% of the Treatment Sessions
The number of participants that attended sessions was monitored by study staff.
Measured: Post-treatment (about 12 weeks)
The Percentage of Participants That Completed All Assessments
Number of participants that completed all assessments (baseline through follow-up) was monitored by study staff.
Measured: Follow-up (about 6 months)
Secondary outcomes (3)
Credibility of Treatment
Credibility will be defined as a mean item-score of 6 or greater on the 1-9 scale of the 6 item Credibility/Expectancy Questionnaire (CEQ). Items 1-3 are specific to credibility and items 4-6 to expectancy.
Measured: 4 weeks
Expectancy of Treatment
Expectancy will be defined as a mean item-score of 6 or greater on the 1-9 scale of the 6 item Credibility/Expectancy Questionnaire (CEQ). Items 1-3 are specific to credibility and items 4-6 to expectancy.
Measured: 4 weeks
Percentage of Participants Who Completed the Weekly Log Sheet
Participants will complete the weekly log sheets that will be monitored by study staff. For the Tai Chi Group participants will record the number of minutes per day spent on home practice. For the Wellness Group, participants will record weekly goals.
Measured: Post treatment (about 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start22 Jun 2023
- Primary completion28 Mar 2025
- Study completion28 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment for Phase One, Random Assignment for Phase Two.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), VA Boston Healthcare System, Tufts Medical Center
- Responsible party
- Sponsor
- Investigators
- Barbara L Niles, PhD, Principal investigator, BUCA School of Medicine, Psychiatry; Boston Veterans Administration
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05693805
- Sponsor's protocol ID
- H-42796
- Other IDs
- 1R34AT011547-01A1
- Status last verified
- May 2026
- First submitted
- 12 Jan 2023
- Last updated
- 20 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Veterans Health Administration (VHA) investigators interested in these data are invited to reach out to discuss data use agreements for the possibility of data sharing. Due to VHA rules related to data sharing and the sensitivity of health records data, data from this project cannot be shared on an open platform.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Remote-Delivery Interventions: Tai Chi and Wellness for PTSD and Pain in Veterans
- ClinicalTrials.gov ID
- NCT05693805
- Acronym / sponsor ID
- H-42796
- Conditions
- PTSD, Pain, Chronic
- Keywords
- Tai Chi, PTSD, Chronic musculoskeletal pain, Veterans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), VA Boston Healthcare System, Tufts Medical Center
- Study start
- 22 Jun 2023 (actual)
- Primary completion
- 28 Mar 2025 (actual)
- Study completion
- 28 Mar 2025 (actual)
- First posted
- 23 Jan 2023 (actual)
- Results
- Posted 28 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the proposed trial, the investigators plan to refine interventions, then conduct a small randomized trial to provide critical information to inform a future large-scale randomized efficacy trial of Tai Chi for Post Traumatic Stress Disorder (PTSD) and chronic pain. Building on the combined experience the proposed study will progress in new directions to:
- 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'.
- Determine the feasibility and acceptability of a remotely delivered randomized trial of these two interventions and the assessment protocols during Phase Two.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment for Phase One, Random Assignment for Phase Two.
| Arm | Type | Receives |
|---|---|---|
| Tai Chi Group | Experimental | Behavioral: Tai ChiParticipants randomized to this arm will receive a standardized Tai Chi protocol developed for veterans, adapted by the investigators, and administered by experienced VA Tai Chi instructors. |
| Wellness Group | Active comparator | Behavioral: Wellness programParticipants randomized to this arm will receive a wellness program that has been successfully used by the investigators in other studies of veterans with chronic pain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Veteran status as indicated by self-report
- PTSD Case Definition. Veterans who meet Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (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 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.
Key exclusion criteria (12 listed)
- 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 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tai ChiThe remote delivery Tai Chi protocol that will be developed in this study for Veterans with PTSD and pain will be adapted from a protocol that has been well-tested in previous trials All components of the program derive from the classical Yang-style Tai Chi 108 postures, which has been shown to be a moderate intensity exercise. Sessions will last 60 minutes, twice a week for 12 weeks. Experienced instructors will follow the Tai Chi protocol with rigorous quality control procedures. We will provide the patients with printed materials on the Tai Chi program, including Tai Chi principles, practice techniques, and safety precautions. Every session will include: warm up and a review of Tai Chi principles; breathing techniques; meditation with Tai Chi movement; and relaxation. | Behavioural | Tai Chi Group |
| Wellness programThe Wellness intervention that will be developed for this study will consist of 60-minute sessions that meet twice a week for 12 weeks, and will be facilitated by doctoral level psychology staff and/or psychology trainees who will be supervised by staff. 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. Using the SMART goals model, participants will set health and wellness goals each week. Discussions about ways to address potential barriers will be included in this condition. | Behavioural | Wellness Group |
Primary outcome
Participant Satisfaction Post Treatment With Interventions Being Tested
Time frame: Post-treatment (about 12 weeks)
Assessed by the self-administered Client Satisfaction Questionnaire (CSQ), an 8-item scale with individual responses ranging from 1 to 4. Higher scores are associated with greater satisfaction with the treatment.
Percentage of Participants Satisfaction at Follow-up With Interventions Being Tested
Time frame: Post-treatment (about 12 weeks)
Percentage of participants that have a mean CSQ item-score of 3 or greater on the 1-4 scale of the 8 original items at post-treatment.
Number of Participants That Attended at Least 70% of the Treatment Sessions
Time frame: Post-treatment (about 12 weeks)
The number of participants that attended sessions was monitored by study staff.
The Percentage of Participants That Completed All Assessments
Time frame: Follow-up (about 6 months)
Number of participants that completed all assessments (baseline through follow-up) was monitored by study staff.
3 secondary outcomes
Credibility of Treatment
Time frame: 4 weeks
Expectancy of Treatment
Time frame: 4 weeks
Percentage of Participants Who Completed the Weekly Log Sheet
Time frame: Post treatment (about 12 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Veterans Health Administration (VHA) investigators interested in these data are invited to reach out to discuss data use agreements for the possibility of data sharing. Due to VHA rules related to data sharing and the sensitivity of health records data, data from this project cannot be shared on an open platform.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara L Niles, PhD principal investigator
BUCA School of Medicine, Psychiatry; Boston Veterans Administration
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi and Wellness program in people with PTSD and Pain, Chronic, run by Boston University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Satisfaction Post Treatment With Interventions Being Tested (time frame: Post-treatment (about 12 weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.