Lifestyle Intervention for PTSD-Related Heart Disease Risk

(I - CHAT Trial)

Overseen By Shay Murphy

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nova Southeastern University

Disqualifiers: Cannot exercise, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

216 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a healthy lifestyle can reduce heart disease risk in people with PTSD (posttraumatic stress disorder). Participants will either follow a healthy lifestyle plan or continue with standard care, such as psychotherapy. It suits individuals with PTSD symptoms who are either overweight or not very active. Those who can walk at a moderate pace might be a good fit. As an unphased trial, this study provides a unique opportunity to contribute to understanding lifestyle impacts on heart health in PTSD patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this lifestyle intervention is safe for individuals with PTSD-related heart disease risk?

Research shows that a healthy lifestyle change is safe for people with PTSD and heart disease risks. Studies have found that these changes can reduce stress and hostility without causing major side effects. One study found that lifestyle improvements can boost heart health in just weeks or months. This approach is not only effective but also well-tolerated by participants. The treatment focuses on behavioral changes, such as diet and exercise, with no reports of serious negative effects. Overall, evidence suggests this is a safe and promising way to manage heart health for those with PTSD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the lifestyle intervention for PTSD-related heart disease risk because it offers a non-pharmaceutical approach to treatment. Unlike traditional options like medication and psychotherapy, this intervention emphasizes healthy lifestyle changes, which may include diet modifications, exercise, and stress management techniques. These changes can potentially reduce heart disease risk factors linked to PTSD without the side effects associated with medications. Additionally, this approach empowers individuals through active participation in their health management, offering a holistic way to address both mental and cardiovascular health.

What evidence suggests that this lifestyle intervention is effective for PTSD-related heart disease risk?

This trial will compare a healthy lifestyle intervention with standard care (psychotherapy) for adults with PTSD who are at risk for heart disease. Research has shown that a healthy lifestyle can greatly benefit these individuals. In a small study with 22 women, lifestyle changes helped them sleep an average of 1.2 hours more each night. Better sleep is important because it can lower stress and improve heart health. Another study found that changes in daily habits can reduce heart disease risks in people with PTSD. These findings suggest that adopting healthier habits could effectively reduce heart-related problems in those with PTSD. ^{3 4 6 7 8}

Who Is on the Research Team?

Jeffrey Kibler, PhD

Principal Investigator

Nova Southeastern University

Are You a Good Fit for This Trial?

This trial is for adults with PTSD who are either overweight or not engaging in moderate physical activity at least five times a week. It's not suitable for those unable to exercise at a low-to-moderate level, like walking.

Inclusion Criteria

Presence of PTSD symptoms

I am overweight or I do less than 150 minutes of moderate exercise weekly.

Exclusion Criteria

I cannot walk or do similar exercises.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a healthy lifestyle intervention alongside usual care psychotherapy to reduce cardiovascular risks and improve CVD markers

12 weeks

Regular visits for intervention sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, with evaluations at 6-month and 12-month time points

12 months

Follow-up evaluations at 6 and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Lifestyle / Healthy Behavior Intervention

Trial Overview The study is testing if a healthy lifestyle program designed for adults with PTSD and cardiovascular risks can improve heart health. Participants will receive standard care plus this special cognitive-behavioral lifestyle intervention.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Healthy lifestyle intervention

Group II: Control Experimental Treatment 1 Intervention

Standard care (psychotherapy)

Who Is Running the Clinical Trial?

Nova Southeastern University

Lead Sponsor

Trials

103

Recruited

12,000+

Published Research Related to This Trial

A 6-week lifestyle intervention program for 15 German patients, which included a low-fat vegetarian diet and aerobic exercises, led to significant dietary changes and improved quality of life, demonstrating its feasibility in a rehabilitation setting.

Despite both the intervention and control groups receiving the same lipid-lowering medication (Pravastatin), the lifestyle changes did not provide additional benefits in lowering lipid levels beyond what the medication achieved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Life style changes in patients with myocardial infarct in the framework of intramural and ambulatory rehabilitation--results of a German pilot study]. Scherwitz, LW., Brusis, OA., Kesten, D., et al.[2013]

Lifestyle medicine empowers patients by encouraging them to take responsibility for their health, showing that healthy lifestyle changes can effectively support the treatment of common mental illnesses like anxiety and PTSD.

The article provides practical examples of how to incorporate evidence-based lifestyle interventions into the treatment plans for these psychiatric conditions, highlighting their potential as valuable adjuncts to traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthy Lifestyle Interventions Augmenting Psychotherapy in Anxiety and PTSD. Correll, T., Gentile, J., Correll, A.[2023]

The Lifestyle Heart Trial (LHT) showed that an intensive lifestyle intervention significantly reduced psychological distress and hostility in participants after one year, highlighting the mental health benefits of lifestyle changes in heart disease management.

By five years, improvements in psychological well-being were maintained in those with high adherence to the program, and lifestyle changes were linked to better cardiac health, including reduced coronary artery stenosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term effects of lifestyle changes on well-being and cardiac variables among coronary heart disease patients. Pischke, CR., Scherwitz, L., Weidner, G., et al.[2022]

A study involving 580 participants with coronary artery disease showed that both the Ornish and Benson-Henry lifestyle modification programs significantly improved cardiac risk factors during a 3-month intervention, with many participants maintaining these improvements for up to 24 months.

Motivation to lose weight was a key factor in sustaining weight loss, highlighting the importance of psychological support in lifestyle interventions for heart disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of lifestyle modification programs on cardiac risk factors. Razavi, M., Fournier, S., Shepard, DS., et al.[2020]

A significant association was found between clinically meaningful improvement in PTSD symptoms (≥20 point decrease in PCL scores) and a 57% increased likelihood of smoking cessation among veterans, indicating that addressing PTSD can positively impact smoking habits.

In a study of 449 veterans with PTSD, 32.7% quit smoking within two years after their PTSD treatment, suggesting that improving mental health may enhance self-efficacy and support smoking cessation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PTSD symptom improvement and smoking cessation among a sample of veterans. Salas, J., Gillis, A., Schneider, D., et al.[2023]

Patients with significant improvements in PTSD symptoms (defined as a decrease of 20 points on the PTSD Checklist) were 37% more likely to utilize weight loss programs, indicating a positive association between PTSD improvement and engagement in health behaviors.

Despite increased utilization of weight loss programs among those with improved PTSD, the extent of PTSD improvement did not correlate with the number of weight loss encounters, suggesting that while PTSD improvement encourages seeking help, it may not directly lead to better weight loss outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PTSD symptom decrease and use of weight loss programs. Scherrer, JF., Salas, J., Chard, KM., et al.[2020]

In a study of 194,319 veterans, PTSD was found to significantly increase the risk of developing hypertension, with hazard ratios ranging from 1.12 to 1.30 over a median follow-up of 2.4 years.

Treatment for PTSD, including psychotherapy and medication, was shown to reduce the risk of hypertension associated with PTSD, highlighting the importance of early intervention in managing long-term health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk for Incident Hypertension Associated With Posttraumatic Stress Disorder in Military Veterans and the Effect of Posttraumatic Stress Disorder Treatment. Burg, MM., Brandt, C., Buta, E., et al.[2018]

Treatments for PTSD, such as cognitive behavioral therapy, prolonged exposure therapy, and SSRIs, have been linked to improvements in cardiovascular health, including better heart rate variability and blood pressure.

Despite these promising findings, the results should be interpreted cautiously due to small sample sizes and a predominance of military populations in the studies, highlighting the need for further research to confirm these benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How does PTSD treatment affect cardiovascular, diabetes and metabolic disease risk factors and outcomes? A systematic review. van den Berk Clark, C., Kansara, V., Fedorova, M., et al.[2023]

In a study of 72 participants in a lifestyle modification program, those with elevated cardiovascular disease (CVD) risk factors but no clinical disease showed equal or greater improvements in heart health compared to those with existing CVD.

The results indicate that intensive lifestyle change programs can be effective for primary prevention of CVD, highlighting their importance for individuals at increased risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensive lifestyle modification: impact on cardiovascular disease risk factors in subjects with and without clinical cardiovascular disease. Ellsworth, DL., O'Dowd, SC., Salami, B., et al.[2019]

A comprehensive lifestyle behavior change program for 292 participants with coronary artery disease led to significant improvements in health outcomes, including better blood lipids, increased exercise capacity, and reduced body mass index over a year of follow-up.

Participants also reported enhanced quality of life and positive changes in psychological factors like anger and hostility, indicating the program's effectiveness in both physical and mental health rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multifactorial evaluation of a program for lifestyle behavior change in rehabilitation and secondary prevention of coronary artery disease. Lisspers, J., Hofman-Bang, C., Nordlander, R., et al.[2019]

A pilot study involving 22 women with PTSD showed that a healthy lifestyle intervention significantly increased sleep duration by an average of 1.2 hours per night compared to a control group, indicating potential benefits for cardiovascular health.

While the intervention group also reported increased physical activity (an average of 115.8 minutes more per week), this change was not statistically significant, suggesting that larger studies are needed to confirm these effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Findings Indicate a Cognitive Behavioral Healthy Lifestyle Intervention for PTSD Improves Sleep and Physical Activity. Kibler, J., Ma, M., Hrzich, J., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10669697/

Pilot Findings Indicate a Cognitive Behavioral Healthy ... The purpose of the present pilot study was to examine the effects of a healthy lifestyle intervention that addresses CVD-related heath behaviors.

2. withpower.com withpower.com/trial/phase-stress-disorders-traumatic-8-2022-fda92

Lifestyle Intervention for PTSD-Related Heart Disease Risk A pilot study involving 22 women with PTSD showed that a healthy lifestyle intervention significantly increased sleep duration by an average of 1.2 hours per ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12384471/

Preliminary Results from an RCT Examining the Effects of a ... The effects of a cognitive behavioral healthy lifestyle intervention for cardiovascular risk reduction in posttraumatic stress disorder.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0146280624002718

Cardiovascular impact of post-traumatic stress disorder This meta-analysis confirms a significant association between PTSD and an increased risk of several cardiovascular outcomes.

5. researchgate.net researchgate.net/publication/394914021_Preliminary_Results_from_an_RCT_Examining_the_Effects_of_a_Health_Behavior_Intervention_as_an_Adjunct_to_Standard_Trauma_Therapy_Among_Adults_with_PTSD

Preliminary Results from an RCT Examining the Effects of a ... The need for effective interventions for CVD risk-reduction in PTSD is increasingly evident. In this paper we present preliminary results from a ...

6. ahajournals.org ahajournals.org/doi/10.1161/CIRCRESAHA.123.321998

Life Course Cardiovascular Health: Risk Factors ... The results demonstrate that it is possible to change cardiovascular risk in a few weeks or months and may be combined with successful lifestyle ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0033062023000348

Cardiology and lifestyle medicine A new field of Lifestyle Medicine, whose mission is to prevent, treat, and even reverse chronic diseases through lifestyle interventions.

8. mdpi.com mdpi.com/2076-3425/13/11/1565

Pilot Findings Indicate a Cognitive Behavioral Healthy ... The purpose of the present pilot study was to examine the effects of a healthy lifestyle intervention that addresses CVD-related heath behaviors.