VA Boston Healthcare System
Boston, Massachusetts, 02130, United States
NCT Number: NCT05693805
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02130, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Post-treatment (about 12 weeks)
Assessed by the self-administered Client Satisfaction Questionnaire (CSQ), an 8-item scale with individual responses ranging from 1 to 4. Higher scores are associated with greater satisfaction with the treatment.
Time frame: Post-treatment (about 12 weeks)
Percentage of participants that have a mean CSQ item-score of 3 or greater on the 1-4 scale of the 8 original items at post-treatment.
Time frame: Post-treatment (about 12 weeks)
The number of participants that attended sessions was monitored by study staff.
Time frame: Follow-up (about 6 months)
Number of participants that completed all assessments (baseline through follow-up) was monitored by study staff.
Time frame: 4 weeks
Credibility will be defined as a mean item-score of 6 or greater on the 1-9 scale of the 6 item Credibility/Expectancy Questionnaire (CEQ). Items 1-3 are specific to credibility and items 4-6 to expectancy.
Time frame: 4 weeks
Expectancy will be defined as a mean item-score of 6 or greater on the 1-9 scale of the 6 item Credibility/Expectancy Questionnaire (CEQ). Items 1-3 are specific to credibility and items 4-6 to expectancy.
Time frame: Post treatment (about 12 weeks)
Participants will complete the weekly log sheets that will be monitored by study staff. For the Tai Chi Group participants will record the number of minutes per day spent on home practice. For the Wellness Group, participants will record weekly goals.
Boston University
Other
Feasibility of Remote-Delivery Interventions: Tai Chi and Wellness for PTSD and Pain in Veterans
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