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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
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Despite the considerable efforts of the DoD and VA to improve awareness of mental health problems and access to care, many returning veterans still report substantial barriers to seeking traditional mental health care. Research suggests that a significant barrier to pursuing treatment is the perception of stigma (Hoge at al., 2004). The primary objective of this 12-week pilot, randomized controlled trial (RCT) is to obtain pilot data on the utilization and efficacy of a standardized, integrative exercise protocol (aerobic exercise and mindful breath training) in addressing global post-traumatic stress disorder (PTSD) symptoms, sleep disturbances, and non-sleep PTSD symptoms in veterans with PTSD. Specifically, this study will examine whether a 12-week course of Integrative Exercise therapy, a treatment lacking stigma, 1) produces significant pre-post improvements in PTSD symptoms and sleep disturbances (compared to a Monitor Only Waitlist condition) 2) improves other clinical outcomes including mood, alcohol and non-alcohol substance use, psychological distress, mindfulness, and overall quality of life (compared to a Monitor Only Waitlist condition) and 3) whether such treatment is feasible and acceptable.
A secondary aim of this study is to evaluate possible mechanisms underlying these effects such as chemicals in the blood related to stress, changes in brain imaging markers, aerobic capacity, and improved sleep.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Integrative Exercise | Experimental | Subjects will exercise for 12 weeks (3 times weekly, with each total workout being approximately 60 minutes in length). The exercise protocol will incorporate elements of mindfulness, cardiovascular strengthening, and controlled breathing. |
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| Monitor Only Waitlist | Active Comparator | Monitor Only Waitlist |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Integrative Exercise | Behavioral |
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| Monitor Only Waitlist |
| Measure | Description | Time Frame |
|---|---|---|
| Clinician Administered PTSD Scale (CAPS) score comparison between subjects randomized to Integrative Exercise Treatment vs. Monitor Only | 12 weeks | |
| Self-reported sleep quality comparison between subjects randomized to Integrative Exercise Treatment vs. Monitor Only | 12 weeks | |
| Hippocampal subfield volume comparison between subjects randomized to Integrative Exercise Treatment vs. Monitor Only | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stress and Health Research Program, University of California San Francisco | San Francisco | California | 94121 | United States |
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| Behavioral |
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