Integrative Exercise for Post-Deployment Stress

PTSD Symptoms Clinical Trial

Official title:

Integrative Exercise for Post-Deployment Stress

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01674244
• Other study ID #: 12-09594
• Status: Completed
• Phase: N/A
• Start date: March 1, 2013
• Est. completion date: August 1, 2015

Study information

• Verified date: September 2020
• Source: Northern California Institute of Research and Education
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 1, 2015
• Est. primary completion date: August 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• PTSD Symptoms

Intervention

Behavioral:
• Integrative Exercise

• Monitor Only Waitlist

Locations

Country	Name	City	State
United States	Stress and Health Research Program, University of California San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Northern California Institute of Research and Education	University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician Administered PTSD Scale (CAPS) score comparison between subjects randomized to Integrative Exercise Treatment vs. Monitor Only		12 weeks
Primary	Self-reported sleep quality comparison between subjects randomized to Integrative Exercise Treatment vs. Monitor Only		12 weeks
Primary	Hippocampal subfield volume comparison between subjects randomized to Integrative Exercise Treatment vs. Monitor Only		12 weeks