Tai Chi and Wellness Education for Older Veterans
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 60 - 100 |
| Updated: | 10/13/2018 |
| Start Date: | November 2018 |
| End Date: | November 2019 |
| Contact: | Anica Pless Kaiser, PhD |
| Email: | Anica.PlessKaiser@va.gov |
| Phone: | 857-364-5309 |
A Randomized Pilot Trial of Tai Chi Compared to Wellness Education for Older Veterans
The primary purpose of this study is to examine physical fitness, PTSD, and satisfaction with
a Tai Chi intervention for older (aged 60 and older), sedentary, trauma-exposed veterans, in
comparison to a wellness education attention control. Secondary outcomes include physical
activity, depression, well-being, late-onset stress, functional status, cognition, and
exercise self-efficacy. Outcomes will be examined pre- to post-intervention and in comparison
to the control condition.
a Tai Chi intervention for older (aged 60 and older), sedentary, trauma-exposed veterans, in
comparison to a wellness education attention control. Secondary outcomes include physical
activity, depression, well-being, late-onset stress, functional status, cognition, and
exercise self-efficacy. Outcomes will be examined pre- to post-intervention and in comparison
to the control condition.
The proposed study will consist of a pilot trial of three 12-week, 24-session Tai Chi
intervention groups compared with three 12-week, 24-session wellness education control
groups. Participants will be randomly assigned in blocks of 14 to either the Tai Chi or the
wellness education condition, half to each. Veterans who do not agree to randomization will
be excluded. Baseline and post-intervention assessments will be completed, and it is
anticipated that 42 individuals will complete baseline assessments. After the final sessions,
participants will be asked to provide feedback to investigators via questionnaires, a focus
group discussion, and individual interviews utilizing open-ended questions. Information
collected from participants will be integrated and utilized for presentations/manuscript
preparation, as well as to refine protocols for use in future research.
Potentially eligible veterans who have expressed interest in the study will be called and
research staff will describe all aspects of the study. Research staff will answer any
questions, and then obtain oral consent for screening for eligibility criteria in the medical
record. Study staff will then go through the eligibility criteria over the telephone and
schedule a baseline assessment as appropriate. Participants will be mailed information about
the time and location for the initial baseline assessment and the class schedule and location
to which they are assigned. They will also receive phone calls with this information.
Information collected during the telephone screening (prior to completion of the Informed
Consent Form) will be collected and retained with the prospective participant's verbal
permission. This information will be kept separate from identifying information (names,
addresses, and telephone numbers). Some information collected from the electronic medical
record will be recorded in order to document inclusion and exclusion criteria.
intervention groups compared with three 12-week, 24-session wellness education control
groups. Participants will be randomly assigned in blocks of 14 to either the Tai Chi or the
wellness education condition, half to each. Veterans who do not agree to randomization will
be excluded. Baseline and post-intervention assessments will be completed, and it is
anticipated that 42 individuals will complete baseline assessments. After the final sessions,
participants will be asked to provide feedback to investigators via questionnaires, a focus
group discussion, and individual interviews utilizing open-ended questions. Information
collected from participants will be integrated and utilized for presentations/manuscript
preparation, as well as to refine protocols for use in future research.
Potentially eligible veterans who have expressed interest in the study will be called and
research staff will describe all aspects of the study. Research staff will answer any
questions, and then obtain oral consent for screening for eligibility criteria in the medical
record. Study staff will then go through the eligibility criteria over the telephone and
schedule a baseline assessment as appropriate. Participants will be mailed information about
the time and location for the initial baseline assessment and the class schedule and location
to which they are assigned. They will also receive phone calls with this information.
Information collected during the telephone screening (prior to completion of the Informed
Consent Form) will be collected and retained with the prospective participant's verbal
permission. This information will be kept separate from identifying information (names,
addresses, and telephone numbers). Some information collected from the electronic medical
record will be recorded in order to document inclusion and exclusion criteria.
Inclusion Criteria:
- Age 60 or older
- Have experienced a traumatic event (determined through telephone screening)
- English-speaking
- Considered to be sedentary
- Not planning to relocate in the next three months
- Reports ability to attend group sessions.
Exclusion Criteria:
- Lacks the capacity to provide consent
- Unable to stand for the duration of a 60-minute Tai Chi intervention
- Has major medical, psychiatric, or neurological disorder or has a moderate or severe
traumatic brain injury,
- Change in psychotropic or pain medication during the past month
- Regular current Tai Chi, formal mindfulness meditation program, or yoga practice
- Unwillingness to be randomly assigned to group
- Engagement in another treatment study that might impact findings
We found this trial at
1
site
Boston, Massachusetts 02130
Principal Investigator: Anica Pless Kaiser, PhD
Phone: 857-364-5309
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