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Remote Tai Chi for PTSD and Chronic Pain
N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up follow-up (about 6 months)
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am a veteran diagnosed with PTSD by a professional using the CAPS-5 scale.
Select...
I have had pain in my muscles or bones in one or more areas for over six months.
Select...
I can attend the scheduled group sessions.
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Participant adherence with completion of assessments
Participant adherence with intervention group sessions
Participant satisfaction at follow-up with interventions being tested
+1 moreSecondary outcome measures
Burden of administration of the Clinician Administered PTSD Scale, 5th Edition (CAPS-5)
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
Find a Location
Who is running the clinical trial?
Tufts Medical CenterOTHER
255 Previous Clinical Trials
255,210 Total Patients Enrolled
Boston UniversityLead Sponsor
454 Previous Clinical Trials
9,941,522 Total Patients Enrolled
National Center for Complementary and Integrative Health (NCCIH)NIH
832 Previous Clinical Trials
668,925 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.You have recently been hospitalized for mental health reasons, are in a drug or alcohol rehab program, or have attempted suicide in the past year.I am willing to wait on starting certain mental health therapies until after the study.You regularly practice Tai Chi, mindfulness meditation, or yoga for at least three hours per week for more than three months. Veterans with past experience who don't practice at this level now can still participate.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.I am unable to understand or sign a consent form.I am a veteran.I can attend the scheduled group sessions.You have been advised by a doctor not to do any physical activity unless approved by a medical team.You have a medical condition that prevents you from safely doing physical activities.
Research Study Groups:
This trial has the following groups:- Group 1: Tai Chi Group
- Group 2: Wellness Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there an opportunity for individuals to partake in this experiment?
"As per the details on clinicaltrials.gov, there is no need for additional participants at this time. The study was first uploaded to the website in March of 2023 and then revised in December of that same year. Even though it has not been recently updated, 697 other medical trials are still open to recruit patients currently."
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