Feasibility of Remote Tai Chi

NCT05693805 | Completed Results

• 2 other identifiers: H-427961R34AT011547-01A1
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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. Building on the combined experience the proposed study will progress in new directions to:

1. 1.Adapt, refine, and standardize two 12-week treatment protocols (Tai Chi and a Wellness control condition) for Veterans diagnosed with PTSD and chronic musculoskeletal pain during Phase One. Tai Chi and Wellness interventions will be adapted for delivery via a videoconferencing platform for the population and piloted in a 'dry run'.
2. 2.Determine the feasibility and acceptability of a remotely delivered randomized trial of these two interventions and the assessment protocols during Phase Two.
3. 3.Utilize information from this trial to plan and design a large randomized control study evaluating the efficacy of Tai Chi compared to Wellness for improving outcomes for Veterans with PTSD and chronic musculoskeletal pain.

Conditions

PTSD; Pain, Chronic

Keywords

Tai Chi; PTSD; Chronic musculoskeletal pain; Veterans

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Follow-up (about 6 months)

Secondary Outcomes (3)

• Credibility of Treatment

  4 weeks

• Expectancy of Treatment

  4 weeks

• Percentage of Participants Who Completed the Weekly Log Sheet

  Post treatment (about 12 weeks)

Study Arms (2)

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.

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.

Behavioral: Wellness program

Interventions

Tai Chi BEHAVIORAL

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.

Tai Chi Group

Wellness program BEHAVIORAL

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.

Wellness Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Boston University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• VA Boston Healthcare System: collaborator
• Tufts Medical Center: collaborator

Study Sites (1)

VA Boston Healthcare System

Boston, Massachusetts, 02130, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Chronic Pain

Interventions

Tai Ji; Health Promotion

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities; Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Barbara L Niles, PhD
• Organization: BUCA School of Medicine, Psychiatry; Boston Veterans Administration

barbara.niles@va.gov

857-364-4128

Study Officials

• Barbara L Niles, PhD

  BUCA School of Medicine, Psychiatry; Boston Veterans Administration

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The blinded evaluator will utilize remote videoconferencing to conduct structured interviews and assess each participant at baseline (prior to randomization), and post-treatment, and (for Phase Two only) at 3-month follow-up.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment for Phase One, Random Assignment for Phase Two.

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: January 23, 2023
• Study Start: June 22, 2023
• Primary Completion: March 28, 2025
• Study Completion: March 28, 2025
• Last Updated: November 28, 2025
• Results First Posted: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: January 2027 to December 2028
• Access Criteria: Investigators interested in these data are invited to reach out to discuss data use agreements for the possibility of data sharing.

Locations

US (1)