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Investigating Cardiac Health of Adults With Trauma (I - CHAT)

Primary Purpose

Posttraumatic Stress Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyle / Healthy Behavior Intervention
standard care
Sponsored by
Nova Southeastern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring Posttraumatic Stress, Cardiovascular, Health, Intervention, PTSD, Lifestyle, Behavior

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • College of Psychology, Nova Southeastern UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intervention

Control

Arm Description

Healthy lifestyle intervention

Standard care (psychotherapy)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 4, 2023
Last Updated
January 17, 2023
Sponsor
Nova Southeastern University
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1. Study Identification

Unique Protocol Identification Number
NCT05700201
Brief Title
Investigating Cardiac Health of Adults With Trauma
Acronym
I - CHAT
Official Title
The Effects of a Cognitive Behavioral Healthy Lifestyle Intervention for Cardiovascular Risk Reduction in Posttraumatic Stress Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
August 2026 (Anticipated)
Study Completion Date
August 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nova Southeastern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This project will test whether a healthy lifestyle intervention, specifically designed for adults with posttraumatic stress and identified cardiovascular risks, is effective in improving cardiovascular health. Therefore, this study will provide information needed to evaluate the potential benefits of cognitive-behavioral lifestyle interventions for addressing barriers to healthy behavior in this at-risk population and reducing risks for heart disease.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
Posttraumatic Stress, Cardiovascular, Health, Intervention, PTSD, Lifestyle, Behavior

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This intervention study will examine 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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
216 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Healthy lifestyle intervention
Arm Title
Control
Arm Type
Experimental
Arm Description
Standard care (psychotherapy)
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle / Healthy Behavior Intervention
Intervention Description
12-session healthy lifestyle program focused on physical activity, nutrition, sleep, and stress management.
Intervention Type
Other
Intervention Name(s)
standard care
Intervention Description
Standard care (psychotherapy)
Primary Outcome Measure Information:
Title
Physical activity
Description
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Arterial Stiffness
Description
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
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abby Dopico
Phone
954-262-5942
Email
whs.nsu@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jeffrey Kibler, PhD
Email
kibler@nova.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Kibler, PhD
Organizational Affiliation
Nova Southeastern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
College of Psychology, Nova Southeastern University
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33314
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Kibler, PhD
First Name & Middle Initial & Last Name & Degree
Jeffrey Kibler, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Investigating Cardiac Health of Adults With Trauma

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