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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34AT011547-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| VA Boston Healthcare System | FED |
| Tufts Medical Center | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tai Chi Group | Experimental | 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. |
|
| Wellness Group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tai Chi | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. Higher scores are associated with greater satisfaction with the treatment. | Post-treatment (about 12 weeks) |
| Percentage of Participants Satisfaction at Follow-up With Interventions Being Tested | 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. | Post-treatment (about 12 weeks) |
| Number of Participants That Attended at Least 70% of the Treatment Sessions | The number of participants that attended sessions was monitored by study staff. | Post-treatment (about 12 weeks) |
| The Percentage of Participants That Completed All Assessments | Number of participants that completed all assessments (baseline through follow-up) was monitored by study staff. | Follow-up (about 6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Credibility of Treatment | 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. | 4 weeks |
| Expectancy of Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara L Niles, PhD | BUCA School of Medicine, Psychiatry; Boston Veterans Administration | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Boston Healthcare System | Boston | Massachusetts | 02130 | United States |
Veterans Health Administration (VHA) investigators interested in these data are invited to reach out to discuss data use agreements for the possibility of data sharing. Due to VHA rules related to data sharing and the sensitivity of health records data, data from this project cannot be shared on an open platform.
January 2027 to December 2028
Investigators interested in these data are invited to reach out to discuss data use agreements for the possibility of data sharing.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tai Chi Group | 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. |
| FG001 | Wellness Group | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Tai Chi Group | 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. |
| BG001 | Wellness Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. Higher scores are associated with greater satisfaction with the treatment. | CSQ data are not available for 3 participants in the Tai Chi Groups and 3 participants in the Wellness Group. | Posted | Mean | Standard Deviation | score on a scale | Post-treatment (about 12 weeks) |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tai Chi Group | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Barbara L Niles, PhD | BUCA School of Medicine, Psychiatry; Boston Veterans Administration | 857-364-4128 | barbara.niles@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 5, 2024 | Nov 5, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 2, 2023 | Apr 30, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D026302 | Tai Ji |
| D006293 | Health Promotion |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026241 | Exercise Movement Techniques |
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Parallel Assignment for Phase One, Random Assignment for Phase Two.
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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.
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| Wellness program | Behavioral | 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. |
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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. |
| 4 weeks |
| Percentage of Participants Who Completed the Weekly Log Sheet | 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. | Post treatment (about 12 weeks) |
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.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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. |
|
|
| Primary | Percentage of Participants Satisfaction at Follow-up With Interventions Being Tested | 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. | CSQ data are not available for 3 participants in the Tai Chi Groups and 3 participants in the Wellness Group. | Posted | Count of Participants | Participants | Post-treatment (about 12 weeks) |
|
|
|
| Primary | Number of Participants That Attended at Least 70% of the Treatment Sessions | The number of participants that attended sessions was monitored by study staff. | Posted | Count of Participants | Participants | Post-treatment (about 12 weeks) |
|
|
|
| Primary | The Percentage of Participants That Completed All Assessments | Number of participants that completed all assessments (baseline through follow-up) was monitored by study staff. | Posted | Count of Participants | Participants | Follow-up (about 6 months) |
|
|
|
| Secondary | Credibility of Treatment | 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. | CEQ data are not available for 2 participants in the Tai Chi Groups and 3 participants in the Wellness Group. | Posted | Count of Participants | Participants | 4 weeks |
|
|
|
| Secondary | Expectancy of Treatment | 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. | CEQ data are not available for 2 participants in the Tai Chi Groups and 3 participants in the Wellness Group. | Posted | Count of Participants | Participants | 4 weeks |
|
|
|
| Secondary | Percentage of Participants Who Completed the Weekly Log Sheet | 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. | Posted | Count of Participants | Participants | Post treatment (about 12 weeks) |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Wellness Group | 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. | 0 | 21 | 0 | 21 | 0 | 21 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D026741 |
| Physical Therapy Modalities |
| D006266 | Health Education |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |