Investigating Cardiac Health of Adults With Trauma

NCT05700201 | Recruiting DMC

• 1 other identifier: 1R15HL165308-01
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Posttraumatic Stress Disorder

Keywords

Posttraumatic Stress; Cardiovascular; Health; Intervention; PTSD; Lifestyle; Behavior

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Arterial Stiffness

  1 year

Study Arms (2)

Intervention

EXPERIMENTAL

Healthy lifestyle intervention

Behavioral: Lifestyle / Healthy Behavior Intervention

Control

EXPERIMENTAL

Standard care (psychotherapy)

Other: standard care

Interventions

Lifestyle / Healthy Behavior Intervention BEHAVIORAL

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

Intervention

standard care OTHER

Standard care (psychotherapy)

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PTSD symptoms
• overweight OR less than 30 min. of moderate physical activity 5 times per week

You may not qualify if:

• cannot exercise at a low-moderate level (walking)

Sponsors & Collaborators

• Nova Southeastern University: lead

Study Sites (1)

College of Psychology, Nova Southeastern University

Fort Lauderdale, Florida, 33314, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Behavior

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jeffrey Kibler, PhD

  Nova Southeastern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shay Murphy

CONTACT

954-262-5942; whs.nsu@gmail.com

Jeffrey Kibler, PhD

CONTACT

kibler@nova.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This study involves examining 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.

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: January 26, 2023
• Study Start: April 21, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: July 29, 2025

Record last verified: 2025-07

Locations

US (1)