Investigating Cardiac Health of Adults With Trauma

NCT ID: NCT05700201

Last Updated: 2025-07-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-21
• Study Completion Date: 2026-08-31

Brief Summary

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.

Conditions

Posttraumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

Healthy lifestyle intervention

Group Type: EXPERIMENTAL

Lifestyle / Healthy Behavior Intervention

Intervention Type: BEHAVIORAL

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

Control

Standard care (psychotherapy)

Group Type: EXPERIMENTAL

standard care

Intervention Type: OTHER

Standard care (psychotherapy)

Interventions

Lifestyle / Healthy Behavior Intervention

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

Intervention Type: BEHAVIORAL

standard care

Standard care (psychotherapy)

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nova Southeastern University

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey Kibler, Ph.D.

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeffrey Kibler, PhD

Role: PRINCIPAL_INVESTIGATOR

Nova Southeastern University

Locations

College of Psychology, Nova Southeastern University

Fort Lauderdale, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Shay Murphy

Role: CONTACT

whs.nsu@gmail.com

954-262-5942

Jeffrey Kibler, PhD

Role: CONTACT

kibler@nova.edu

Facility Contacts

Jeffrey Kibler, PhD

Role: primary

Other Identifiers

1R15HL165308-01

Identifier Type: NIH

Identifier Source: org_study_id

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