Integrative Exercise for Post-Deployment Stress

NCT01674244 | Completed DMC

• 1 other identifier: 12-09594
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

PTSD Symptoms

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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.

Behavioral: Integrative Exercise

Monitor Only Waitlist

ACTIVE COMPARATOR

Monitor Only Waitlist

Behavioral: Monitor Only Waitlist

Interventions

Integrative Exercise BEHAVIORAL

Integrative Exercise

Monitor Only Waitlist BEHAVIORAL

Monitor Only Waitlist

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Northern California Institute of Research and Education: lead
• University of California, San Francisco: collaborator

Study Sites (1)

Stress and Health Research Program, University of California San Francisco

San Francisco, California, 94121, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Residence

Study Record Dates

• First Submitted: August 24, 2012
• First Posted: August 28, 2012
• Study Start: March 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 16, 2020

Record last verified: 2020-09

Locations

US (1)