Investigating Cardiac Health of Adults With Trauma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lifestyle / Healthy Behavior Intervention, standard care.
- Who it may be relevant to
- Registry conditions: Posttraumatic Stress Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Effects of a Cognitive Behavioral Healthy Lifestyle Intervention for Cardiovascular Risk Reduction in Posttraumatic Stress Disorder
Overview
This project examines the impact of a healthy lifestyle intervention, specifically designed for adults with posttraumatic stress and identified cardiovascular risks.
Detailed description
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.
Interventions
- Behavioral Lifestyle / Healthy Behavior Intervention
12-session healthy lifestyle program focused on physical activity, nutrition, sleep, and stress management. - Other standard care
Standard care (psychotherapy)
Primary outcome measures
- Physical activity [Time frame: 1 year]
Secondary outcome measures (1)
- Arterial Stiffness [Time frame: 1 year]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- College of Psychology, Nova Southeastern University — Fort Lauderdale
Identifiers
NCT: NCT05700201 · 1R15HL165308-01