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NCT Number: NCT05700201

Investigating Cardiac Health of Adults With Trauma

This project examines the impact of a healthy lifestyle intervention, specifically designed for adults with posttraumatic stress and identified cardiovascular risks.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

College of Psychology, Nova Southeastern University

Fort Lauderdale, Florida, 33314, United States

Location status: Recruiting

Location contact

Jeffrey Kibler, PhD

CONTACT

Jeffrey Kibler, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Lifestyle / Healthy Behavior Intervention

Behavioral

12-session healthy lifestyle program focused on physical activity, nutrition, sleep, and stress management.

Standard care

Other

Standard care (psychotherapy)

Primary outcomes

  1. Physical activity

    Time frame: 1 year

    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

Secondary outcomes

  1. Arterial Stiffness

    Time frame: 1 year

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Jeffrey Kibler, PhD

CONTACT

[email protected]

Shay Murphy

CONTACT

[email protected]

954-262-5942

Sponsors and collaborators

Lead sponsor

Nova Southeastern University

Other

Registry information

Official study title

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

Acronym: I - CHAT

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2023
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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