Investigating Cardiac Health of Adults With Trauma

Posttraumatic Stress Disorder Clinical Trial

— I - CHAT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05700201
• Other study ID #: 1R15HL165308-01
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: August 2026

Study information

• Verified date: June 2024
• Source: Nova Southeastern University
• Contact: Shay Murphy
• Phone: 954-262-5942
• Email: whs.nsu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 216
• Est. completion date: August 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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)

Locations

Country	Name	City	State
United States	College of Psychology, Nova Southeastern University	Fort Lauderdale	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Nova Southeastern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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