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Investigating Cardiac Health of Adults With Trauma

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05700201
Acronym
I - CHAT
Enrollment
216
Registered
2023-01-26
Start date
2023-04-21
Completion date
2026-08-31
Last updated
2026-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posttraumatic Stress Disorder

Keywords

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

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.

Interventions

BEHAVIORALLifestyle / Healthy Behavior Intervention

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

OTHERstandard care

Standard care (psychotherapy)

Sponsors

Nova Southeastern University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Physical activity1 yearThe 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

MeasureTime frameDescription
Arterial Stiffness1 yearnon-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

Countries

United States

Contacts

CONTACTShay Murphy
whs.nsu@gmail.com954-262-5942
CONTACTJeffrey Kibler, PhD
kibler@nova.edu
PRINCIPAL_INVESTIGATORJeffrey Kibler, PhD

Nova Southeastern University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 7, 2026