Integrative Exercise for Post-Deployment Stress
|ClinicalTrials.gov Identifier: NCT01674244|
Recruitment Status : Unknown
Verified April 2015 by Thomas C. Neylan, M.D., Northern California Institute of Research and Education.
Recruitment status was: Active, not recruiting
First Posted : August 28, 2012
Last Update Posted : April 15, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|PTSD Symptoms||Behavioral: Integrative Exercise Behavioral: Monitor Only Waitlist||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Integrative Exercise for Post-Deployment Stress|
|Study Start Date :||March 2013|
|Estimated Primary Completion Date :||August 2015|
|Estimated Study Completion Date :||August 2015|
Experimental: Integrative Exercise
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.
|Behavioral: Integrative Exercise|
Active Comparator: Monitor Only Waitlist
Monitor Only Waitlist
|Behavioral: Monitor Only Waitlist|
- Clinician Administered PTSD Scale (CAPS) score comparison between subjects randomized to Integrative Exercise Treatment vs. Monitor Only [ Time Frame: 12 weeks ]
- Self-reported sleep quality comparison between subjects randomized to Integrative Exercise Treatment vs. Monitor Only [ Time Frame: 12 weeks ]
- Hippocampal subfield volume comparison between subjects randomized to Integrative Exercise Treatment vs. Monitor Only [ Time Frame: 12 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01674244
|United States, California|
|Stress and Health Research Program, University of California San Francisco|
|San Francisco, California, United States, 94121|