Completed

Integrative Exercise for Post-Deployment Stress

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What is being tested

Integrative Exercise

+ Monitor Only Waitlist

Behavioral
Who is being recruted

From 18 to 65 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: March 2013
See protocol details

Summary

Principal SponsorNorthern California Institute of Research and Education
Last updated: September 16, 2020
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

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.

Principal SponsorNorthern California Institute of Research and Education
Last updated: September 16, 2020
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

2 inclusion criteria required to participate
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

6 exclusion criteria prevent from participating
Currently exposed to recurrent trauma or have been exposed to a traumatic event within the past 3 months

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

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)

Myocardial infarction (MI) in the past 6 months

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Group II

Active Comparator
Monitor Only Waitlist

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Stress and Health Research Program, University of California San Francisco

San Francisco, United StatesOpen Stress and Health Research Program, University of California San Francisco in Google Maps
CompletedOne Study Center