Integrative Exercise for Post-Deployment Stress

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Northern California Institute of Research and Education
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
Thomas C. Neylan, M.D., Northern California Institute of Research and Education
ClinicalTrials.gov Identifier:
NCT01674244
First received: August 24, 2012
Last updated: September 23, 2014
Last verified: September 2014
  Purpose

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 Intervention
PTSD Symptoms
Behavioral: Integrative Exercise
Behavioral: Monitor Only Waitlist

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Integrative Exercise for Post-Deployment Stress

Resource links provided by NLM:


Further study details as provided by Northern California Institute of Research and Education:

Primary Outcome Measures:
  • Clinician Administered PTSD Scale (CAPS) score comparison between subjects randomized to Integrative Exercise Treatment vs. Monitor Only [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Self-reported sleep quality comparison between subjects randomized to Integrative Exercise Treatment vs. Monitor Only [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Hippocampal subfield volume comparison between subjects randomized to Integrative Exercise Treatment vs. Monitor Only [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: March 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01674244

Locations
United States, California
Stress and Health Research Program, University of California San Francisco Recruiting
San Francisco, California, United States, 94121
Contact: Aliza Silver, MA    415-221-4810 ext 2565    Aliza.Silver@va.gov   
Principal Investigator: Thomas Neylan, MD         
Sponsors and Collaborators
Northern California Institute of Research and Education
University of California, San Francisco
  More Information

No publications provided

Responsible Party: Thomas C. Neylan, M.D., Professor in Residence, Northern California Institute of Research and Education
ClinicalTrials.gov Identifier: NCT01674244     History of Changes
Other Study ID Numbers: 12-09594
Study First Received: August 24, 2012
Last Updated: September 23, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 19, 2014