Clinical Trials Directory

Trials / Completed

CompletedNCT01674244

Integrative Exercise for Post-Deployment Stress

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
40 (estimated)
Sponsor
Northern California Institute of Research and Education · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALIntegrative Exercise
BEHAVIORALMonitor Only Waitlist

Timeline

Start date
2013-03-01
Primary completion
2015-08-01
Completion
2015-08-01
First posted
2012-08-28
Last updated
2020-09-16

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01674244. Inclusion in this directory is not an endorsement.