Investigating Cardiac Health of Adults With Trauma

Study Overview
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Brief Summary
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This project will test whether a healthy lifestyle intervention, specifically designed for adults with posttraumatic stress and identified cardiovascular risks, is effective in improving cardiovascular health. Therefore, this study will provide information needed to evaluate the potential benefits of cognitive-behavioral lifestyle interventions for addressing barriers to healthy behavior in this at-risk population and reducing risks for heart disease.

Detailed Description
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Considerable research has indicated strong associations between posttraumatic stress and cardiovascular disease (CVD) risk. Individuals with posttraumatic stress disorder (PTSD) tend to show patterns of elevated CVD risk earlier in life than in the general population. The need for developing effective interventions for CVD risk-reduction in PTSD is increasingly evident. In comparison to the cumulative evidence concerning elevated CVD risk in PTSD, relatively little research has addressed CVD risk-reduction in this population. Adjunctive treatments, such as health behavior interventions, may be necessary as supplements to traditional psychotherapy for PTSD in order to reduce CVD risks. The objective of the proposed project is to examine the effects of a healthy lifestyle intervention that addresses multiple CVD-related heath behaviors among civilian adults across genders (ages 18+), who evidence PTSD and CVD risk at baseline. The investigators will assess the intervention impact on both subjective and objective indices of health behaviors, cardiovascular risks and CVD markers over a one-year timeframe. The healthy lifestyle intervention addresses unique aspects of PTSD symptom presentation that serve as barriers to healthy behaviors (e.g., nightmares/sleep disruption, and cognitive responses to stress), while encouraging healthy lifestyle changes. The primary goal of the present study is to examine whether, compared to a usual care psychotherapy control condition, utilizing the healthy lifestyle intervention as an adjunct to psychotherapy will result in significantly reduced CVD risks and improved CVD markers among civilian adults with PTSD and elevated CVD risks. Therefore, participants will be randomly assigned to either a usual care psychotherapy-only control condition or a usual care psychotherapy plus healthy lifestyle intervention condition. Outcomes will be assessed at post-intervention (12 weeks), as well as 6-month and 12-month time points for follow-up evaluation.

Official Title
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The Effects of a Cognitive Behavioral Healthy Lifestyle Intervention for Cardiovascular Risk Reduction in Posttraumatic Stress Disorder

Conditions
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Posttraumatic Stress Disorder

Intervention / Treatment
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* Behavioral: Lifestyle / Healthy Behavior Intervention
* Other: standard care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PTSD symptoms overweight OR less than 30 min. of moderate physical activity 5 times per week Exclusion Criteria: cannot exercise at a low-moderate level (walking)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This intervention study will examine the effects of a 12-session healthy lifestyle program (focused on physical activity, nutrition, sleep, and stress management) administered in an individual format as an adjunct to usual care psychotherapy, compared with a usual care psychotherapy-only control condition. The control group will only attend the outcome assessments and usual care psychotherapy sessions. Therefore, the design relies on a between-groups comparison of the two conditions.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Healthy lifestyle intervention | Behavioral: Lifestyle / Healthy Behavior Intervention<br>* 12-session healthy lifestyle program focused on physical activity, nutrition, sleep, and stress management.<br>|
| Experimental: Control<br>Standard care (psychotherapy) | Other: standard care<br>* Standard care (psychotherapy)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity | The International Physical Activity Questionnaire (7-Day long form) is a reliable and valid measure that will be used to assess time spent in a variety of moderate and vigorous activities in the past week | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial Stiffness | non-invasive measurement of augmentation index, calculated as the difference between the second and the first systolic peaks and expressed as percentage of the central aortic pulse pressure | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Posttraumatic Stress, Cardiovascular, Health, Intervention, PTSD, Lifestyle, Behavior