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Feasibility of Remote Tai Chi

Primary Purpose

PTSD, Pain, Chronic

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tai Chi
Wellness program
Sponsored by
Boston University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PTSD focused on measuring Tai Chi, PTSD, Chronic musculoskeletal pain, Veterans

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. 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. 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. Exclusion Criteria: 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

Sites / Locations

  • VA Boston Healthcare SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tai Chi Group

Wellness Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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. Individual items are summed to produce a total score that ranges from 8 to 32 with higher scores reflecting greater satisfaction with treatment.
Participant satisfaction at follow-up 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. Individual items are summed to produce a total score that ranges from 8 to 32 with higher scores reflecting greater satisfaction with treatment.
Participant adherence with intervention group sessions
Number of completed remote sessions as monitored by study staff
Participant adherence with completion of assessments
Number of completed remote assessments as monitored by study staff

Secondary Outcome Measures

Burden of administration of the Clinician Administered PTSD Scale, 5th Edition (CAPS-5)
Burden will be measured by the number of minutes to administer the CAPS-5, which is a structured diagnostic interview for PTSD that corresponds to the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for PTSD symptoms. Higher number of minutes are associated with more burden.

Full Information

First Posted
January 12, 2023
Last Updated
June 26, 2023
Sponsor
Boston University
Collaborators
National Center for Complementary and Integrative Health (NCCIH), VA Boston Healthcare System, Tufts Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05693805
Brief Title
Feasibility of Remote Tai Chi
Official Title
Feasibility of Remote-Delivery Interventions: Tai Chi and Wellness for PTSD and Pain in Veterans
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 22, 2023 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston University
Collaborators
National Center for Complementary and Integrative Health (NCCIH), VA Boston Healthcare System, Tufts Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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'. Determine the feasibility and acceptability of a remotely delivered randomized trial of these two interventions and the assessment protocols during Phase Two. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD, Pain, Chronic
Keywords
Tai Chi, PTSD, Chronic musculoskeletal pain, Veterans

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment for Phase One, Random Assignment for Phase Two.
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tai Chi Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Wellness Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Tai Chi
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Wellness program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Participant satisfaction post treatment with interventions being tested
Description
Assessed by the self-administered Client Satisfaction Questionnaire (CSQ), an 8-item scale with individual responses ranging from 1 to 4. Individual items are summed to produce a total score that ranges from 8 to 32 with higher scores reflecting greater satisfaction with treatment.
Time Frame
Post-treatment (about 12 weeks)
Title
Participant satisfaction at follow-up with interventions being tested
Description
Assessed by the self-administered Client Satisfaction Questionnaire (CSQ), an 8-item scale with individual responses ranging from 1 to 4. Individual items are summed to produce a total score that ranges from 8 to 32 with higher scores reflecting greater satisfaction with treatment.
Time Frame
Follow-up (about 6 months)
Title
Participant adherence with intervention group sessions
Description
Number of completed remote sessions as monitored by study staff
Time Frame
Post-treatment (about 12 weeks)
Title
Participant adherence with completion of assessments
Description
Number of completed remote assessments as monitored by study staff
Time Frame
Follow-up (about 6 months)
Secondary Outcome Measure Information:
Title
Burden of administration of the Clinician Administered PTSD Scale, 5th Edition (CAPS-5)
Description
Burden will be measured by the number of minutes to administer the CAPS-5, which is a structured diagnostic interview for PTSD that corresponds to the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for PTSD symptoms. Higher number of minutes are associated with more burden.
Time Frame
Baseline, post-treatment, and (for Phase Two only) 3-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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. 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Barbara L Niles, PhD
Phone
857-364-4128
Email
barbara.niles@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara L Niles, PhD
Organizational Affiliation
Boston Veterans Administration, BUSM Dept of Psych
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Boston Healthcare System
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara L Niles, PhD
Email
barbara.niles@va.gov

12. IPD Sharing Statement

Plan to Share IPD
No

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Feasibility of Remote Tai Chi

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