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Remote Tai Chi for PTSD and Chronic Pain

N/A

Waitlist Available

Led By Barbara L Niles, PhD

Research Sponsored by Boston University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

PTSD Case Definition. Veterans who meet 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

Must not have

Lacks the capacity to provide consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up follow-up (about 6 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial will refine interventions to test the efficacy of Tai Chi vs Wellness to help Veterans with PTSD and chronic pain.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves physical activity (Tai Chi) and wellness programs, side effects may include muscle soreness or strain from exercise. However, these activities are generally low-risk and promote overall well-being.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I can attend the scheduled group sessions.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable to understand or sign a consent form.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ follow-up (about 6 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~follow-up (about 6 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and follow-up (about 6 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Participant adherence with completion of assessments

Participant adherence with intervention group sessions

Participant satisfaction at follow-up with interventions being tested

+1 more

Secondary study objectives

Burden of administration of the Clinician Administered PTSD Scale, 5th Edition (CAPS-5)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Tai Chi GroupExperimental Treatment1 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 GroupActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tai Chi

2014

Completed Phase 2

~1660

0 / 4Eligibility criteria met