Improving Mind/Body Health and Functioning With Integrative Exercise
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stress Disorders, Post-Traumatic
- Sponsor
- VA Office of Research and Development
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- Clinician Administered PTSD Scale (CAPS) Score Comparison Between Subjects Randomized to Integrative Exercise Treatment vs. Illness Management and Recovery
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
There is evidence demonstrating that aerobic exercise improves many symptoms of Posttraumatic Stress Disorder (PTSD) including; anxiety, depression, insomnia, and cognition. With the goal of using exercise as a rehabilitation therapy for Veterans with PTSD, a team of scientists and doctors developed a 12-week exercise program, combining aerobic and strength training with concentration training and mindful breathing techniques. The initial pilot study suggested that Integrative Exercise may improve overall quality of life, sleep quality, cardiovascular fitness, and PTSD symptoms. This new study will help determine the effectiveness of Integrative Exercise compared to health education classes. The overall goal is to determine if integrative exercise is an effective rehabilitation intervention for combat Veterans with PTSD.
Detailed Description
Despite the considerable efforts of the 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. There is a large body of evidence demonstrating that aerobic exercise effectively improves many outcomes relevant to Posttraumatic Stress Disorder (PTSD) including; anxiety, depression, insomnia, cognition, and cardiovascular disease. In addition, there is a rapidly growing evidence base showing that aerobic exercise produces an increase in the growth of new neurons (e.g., neurogenesis) and increases the volume of the hippocampus which underscores the potential value of exercise for producing broad benefits to psychological health. Recognizing the promise that exercise might hold for attracting more Veterans into care and improving overall health in Veterans with PTSD, a team of investigators at the San Francisco Veterans Administration Medical Center (SFVAMC) with funding from the Department of Defense developed a treatment protocol and completed a pilot study of Integrative Exercise (Aerobic exercise and Breath Training 3 weekly sessions over 12 weeks) versus a waitlist control condition. Promising results from this trial have led us to the next step which is to conduct a definitive efficacy study of Integrative Exercise versus an active health education control condition: Illness Management and Recovery (IMR). The control condition will be matched on contact hours with treatment personnel. The goal of this revised proposal is to test if Integrative Exercise improves overall quality of life, PTSD symptoms, sleep quality, and measures of cardiovascular health in combat Veterans with chronic PTSD relative to the IMR condition. Another goal is to test if improvements in quality of life are predicted by improvements in cardiovascular fitness as measured by exercise capacity on treadmill testing. Finally, the proposal will test if Integrative Exercise versus IMR will produce greater improvements in additional health outcomes, including mood, subjective sleep quality, and PTSD symptoms.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Veterans (Male and Female) between the ages of 18-75 who are physically able to participate in an exercise program
- •Meet criteria for PTSD of at least 3 months duration, OR have some symptoms of PTSD with a current CAPS score of 23 or higher, as indexed by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
Exclusion Criteria
- •History of any psychiatric disorder with active psychosis or mania in the past 5 years
- •Meet criteria for severe drug or alcohol use disorder within the past 6 months as assessed by the Structured Clinical Interview for DSM-5
- •Prominent suicidal or homicidal ideation
- •Currently exposed to recurrent trauma or have been exposed to a traumatic event within the past 3 months
- •Have a clinically significant:
- •neurologic disorder
- •systemic illness affecting central nervous system (CNS) function
- •history of seizure disorder in the past 5 years
- •and/or physical disabilities making it impossible to use exercise equipment
- •Acute coronary events (i.e., Myocardial Infarction) in the past 6 months
Outcomes
Primary Outcomes
Clinician Administered PTSD Scale (CAPS) Score Comparison Between Subjects Randomized to Integrative Exercise Treatment vs. Illness Management and Recovery
Time Frame: 12 weeks
The CAPS-5 is a 20 item scale that provides both a dimensional and categorical measure of PTSD. The CAPS-5 items are rated with a single severity score, ranging from 0-80 with higher scores indicating worse severity, that incorporates both frequency and intensity PTSD-related symptoms. In addition to assessing the 20 DSM-5 PTSD symptoms, questions target the onset and duration of symptoms, subjective distress, impact of symptoms on social and occupational functioning, improvement in symptoms since a previous CAPS administration, overall response validity, overall PTSD severity, and specifications for the dissociative subtype (depersonalization and derealization).
The World Health Organization Quality of Life (WHOQOL-BREF) Score Comparison Between Subjects Randomized to Integrative Exercise Treatment vs. Monitor Only
Time Frame: 12 weeks
The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. The WHOQOL-BREF is a shorter version of the original WHOQOL-100 instrument and is more convenient for use in large research studies or clinical trials. The Psychological Domain, the investigators' primary outcome, is derived from 6 items which index body image, negative \& positive feelings, self-esteem, spirituality, and cognition. Each of the 6 items have 5 response options with higher scores indicating higher psychological health. The mean score of items within each domain is used to calculate the domain score. The domain score is then linearly transformed to scale of 0-100 to enable comparisons between other domains composed of unequal numbers of items. (Skevington et al. Quality of Life Research 13: 299-310, 2004.)
Secondary Outcomes
- Five Facet Mindfulness Questionnaire (FFMQ)- Observing(12 weeks)
- Godin Leisure-Time Exercise Questionnaire(12 weeks)
- PTSD Checklist for DSM-5 (PCL-5)(12 weeks)
- Symptom Check-List-90-Revised (SCL-90-R)(12 weeks)
- Pittsburgh Sleep Quality Index (PSQI)(12 weeks)
- Insomnia Severity Index (ISI)(12 weeks)