Integrative Exercise for Post-Deployment Stress

Study Overview
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Brief Summary
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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.

Official Title
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Integrative Exercise for Post-Deployment Stress

Conditions
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PTSD Symptoms

Intervention / Treatment
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* Behavioral: Integrative Exercise
* Behavioral: Monitor Only Waitlist


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between the ages of 18-65 and must be physically able to participate in an exercise program Participants will meet criteria for either current, full syndromal PTSD of at least 3 months duration, as indexed by the Clinician Administered PTSD Scale (CAPS) diagnostic criteria or partial PTSD defined by meeting the required number of symptoms in the B symptom cluster as well as the required number of symptoms in either the C or D symptom clusters. Exclusion Criteria: Lifetime history of any psychiatric disorder with psychotic features, bipolar disorder, or mania or meet criteria for drug or alcohol dependence within the past year as assessed by the Structured Clinical Interview for DSM-IV-TR. Prominent suicidal or homicidal ideation Currently exposed to recurrent trauma or have been exposed to a traumatic event within the past 3 months Pregnant, have a clinically significant neurologic disorder, systemic illness affecting CNS function, history of seizure disorder, asthma, and/or physical disabilities making it impossible to use exercise equipment will be excluded Myocardial infarction (MI) in the past 6 months Moderate to severe Traumatic Brain Injury (any history of head trauma associated with the onset of persistent cognitive complaints, neurological symptoms, or loss of consciousness > 5 minutes)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Integrative Exercise<br>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<br> <br> |
| Active Comparator: Monitor Only Waitlist<br>Monitor Only Waitlist | Behavioral: Monitor Only Waitlist<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |