Feasibility of Remote Tai Chi

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston University
Study ID
NCT05693805
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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

Key Dates

Start date
Jun 22, 2023
Status verified
May 2026
Primary completion
Mar 28, 2025
Completion
Mar 28, 2025

Study Design

Enrollment
42 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tai Chi Group
    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.
  • Active Comparator: Wellness Group
    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.

Primary Outcome Measure

Participant Satisfaction Post Treatment With Interventions Being Tested [ Time Frame: Post-treatment (about 12 weeks) ]

Locations (1)

FacilityCityStateZIPSite coordinators
VA Boston Healthcare SystemBostonMassachusetts02130-

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