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

Trial Summary

What is the purpose of this trial?

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

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 data supports the effectiveness of the treatment Lifestyle / Healthy Behavior Intervention, Healthy Lifestyle Intervention, Behavioral Therapy, Lifestyle Modification for PTSD-related heart disease risk?

A pilot study found that a healthy lifestyle intervention for people with PTSD improved sleep by an average of 1.2 hours per night and increased physical activity, suggesting it can help improve behaviors linked to heart health. ^{1 2 3 4 5}

Is the lifestyle intervention for PTSD-related heart disease risk safe?

Lifestyle interventions, which include changes in diet, exercise, and stress management, have been shown to be safe and beneficial for improving heart health and mental well-being in various studies. Participants in these programs often experience improvements in heart disease risk factors and quality of life, with low rates of negative effects. ^{6 7 8 9 10}

How does the Lifestyle / Healthy Behavior Intervention treatment for PTSD-related heart disease risk differ from other treatments?

This treatment is unique because it focuses on empowering patients to make lifestyle changes, such as improving diet, exercise, and stress management, which can help reduce heart disease risk associated with PTSD. Unlike traditional drug therapies, this approach emphasizes patient responsibility and long-term behavior change to improve both mental and physical health. ^{6 7 9 10 11}

Research Team

Jeffrey Kibler, PhD

Principal Investigator

Nova Southeastern University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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 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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Pilot Findings Indicate a Cognitive Behavioral Healthy Lifestyle Intervention for PTSD Improves Sleep and Physical Activity. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

PTSD symptom improvement and smoking cessation among a sample of veterans. [2023]

3. England pubmed.ncbi.nlm.nih.gov

PTSD symptom decrease and use of weight loss programs. [2020]

4. United States 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. [2018]

5. England pubmed.ncbi.nlm.nih.gov

How does PTSD treatment affect cardiovascular, diabetes and metabolic disease risk factors and outcomes? A systematic review. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Healthy Lifestyle Interventions Augmenting Psychotherapy in Anxiety and PTSD. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Intensive lifestyle modification: impact on cardiovascular disease risk factors in subjects with and without clinical cardiovascular disease. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Effects of lifestyle modification programs on cardiac risk factors. [2020]

9. Germany 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]. [2013]

10. England pubmed.ncbi.nlm.nih.gov

Multifactorial evaluation of a program for lifestyle behavior change in rehabilitation and secondary prevention of coronary artery disease. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Long-term effects of lifestyle changes on well-being and cardiac variables among coronary heart disease patients. [2022]