Remote Tai Chi for PTSD and Chronic Pain

Overseen By Barbara L Niles, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston University

Must not be taking: Psychotropic, Pain medications

Disqualifiers: Major medical disorder, TBI, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

55 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Barbara L Niles, PhD

Principal Investigator

Boston Veterans Administration, BUSM Dept of Psych

Eligibility Criteria

This trial is for Veterans with PTSD and chronic musculoskeletal pain lasting over six months, who have internet access for telehealth. They must not start any new evidence-based psychotherapy during the study but can continue if prescribed by a provider. Participants should be able to stand for Tai Chi sessions and attend scheduled intervention times.

Inclusion Criteria

I am willing to wait on starting certain mental health therapies until after the study.

I am a veteran diagnosed with PTSD by a professional using the CAPS-5 scale.

I have had pain in my muscles or bones in one or more areas for over six months.

Exclusion Criteria

I do not have a major illness or severe brain injury that would stop me from safely doing Tai Chi.

I haven't changed my mental health or pain medication in the last month.

I struggle to stand for most of a 60-minute Tai Chi class.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase One: Treatment

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. Interventions are delivered via videoconferencing.

12 weeks

Remote sessions

Phase Two: Feasibility and Acceptability

Determine the feasibility and acceptability of a remotely delivered randomized trial of the two interventions and the assessment protocols.

12 weeks

Remote sessions

Follow-up

Participants are monitored for satisfaction and adherence with interventions post-treatment and at follow-up.

6 months

Treatment Details

Interventions

• Tai Chi
• Wellness program

Trial Overview The trial tests two 12-week interventions delivered remotely: Tai Chi versus a Wellness program, to see which helps more with PTSD and chronic pain in Veterans. It's a small-scale randomized trial meant to set up for a larger future study.

Participant Groups

Group I: Tai Chi Group Experimental Treatment 1 Intervention

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.

Group II: Wellness Group Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Boston University

Lead Sponsor

Trials

494

Recruited

9,998,000+

Tufts Medical Center

Collaborator

Trials

264

Recruited

264,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

VA Boston Healthcare System

Collaborator

Trials

73

Recruited

971,000+