Lifestyle Intervention for PTSD-Related Heart Disease Risk
(I - CHAT Trial)
Recruiting in Palo Alto (17 mi)
Overseen byJeffrey Kibler, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Nova Southeastern University
Disqualifiers: Cannot exercise, others
No Placebo Group
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.
12345Is 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.
678910How 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.
6791011Eligibility 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.
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
Healthy lifestyle intervention
Group II: ControlExperimental Treatment1 Intervention
Standard care (psychotherapy)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
College of Psychology, Nova Southeastern UniversityFort Lauderdale, FL
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Who Is Running the Clinical Trial?
Nova Southeastern UniversityLead Sponsor
References
Pilot Findings Indicate a Cognitive Behavioral Healthy Lifestyle Intervention for PTSD Improves Sleep and Physical Activity. [2023]Research has indicated strong associations between post-traumatic stress and cardiovascular disease (CVD) risk. Individuals with post-traumatic stress disorder (PTSD) tend to show patterns of elevated CVD risk earlier in life than the general population. The need for developing effective interventions for CVD risk reduction in PTSD is increasingly evident. The purpose of the present pilot study was to examine the effects of a healthy lifestyle intervention that addresses CVD-related heath behaviors (physical activity, sleep, stress) among civilian adults with PTSD. Participants were randomized to the healthy lifestyle intervention condition or a wait-list control. A total of 22 women completed the protocol (11 per group). The mean age was 32 (SD ± 14). Evaluations were conducted before and after the 12-week intervention program in the experimental group, and 12 weeks apart for the control group, and included standardized self-report measures of sleep, physical activity, and general stress. The healthy lifestyle group showed an increase in the amount of sleep pre to post (mean of 1.2 h per night), which was significantly different to the control group, who had no change (p < 0.05; effect size = 1.41). Notable pre to post increases in physical activity were observed between the intervention group (mean increase = 115.8 min over 7 days) and control condition (mean = 4.5 min over 7 days); however, this effect was not significant in the small sample (effect size = 0.70). These preliminary findings suggest that a healthy lifestyle intervention is feasible and can produce desired changes in target behaviors/outcomes.
PTSD symptom improvement and smoking cessation among a sample of veterans. [2023]Context: Poor health behaviors are common in persons with posttraumatic stress disorder (PTSD). PTSD symptom improvement has been followed by better health behaviors such as medication adherence and use of nutrition, weight loss, and substance abuse treatment programs. Whether PTSD improvement is associated with smoking cessation is uncertain. Objective: To determine if patients with, compared to without, clinically meaningful improvement (≥20 points vs.
PTSD symptom decrease and use of weight loss programs. [2020]Posttraumatic stress disorder (PTSD) is associated with poor health behaviors, including low utilization of Veteran Health Affairs (VHA) weight loss programs. It is not known if clinically meaningful PTSD improvement is associated with increased use of weight loss programs.
Risk for Incident Hypertension Associated With Posttraumatic Stress Disorder in Military Veterans and the Effect of Posttraumatic Stress Disorder Treatment. [2018]Posttraumatic stress disorder (PTSD) increases cardiovascular disease and cardiovascular mortality risk. Neither the prospective relationship of PTSD to incident hypertension risk nor the effect of PTSD treatment on hypertension risk has been established.
How does PTSD treatment affect cardiovascular, diabetes and metabolic disease risk factors and outcomes? A systematic review. [2023]Prior research indicates PTSD is associated with cardiovascular and metabolic disease. A number of different treatments for PTSD can be effective in reducing PTSD symptoms. The aim of this study is to systematically review studies which determine whether treatment for PTSD is associated with better cardiovascular and metabolic outcomes.
Healthy Lifestyle Interventions Augmenting Psychotherapy in Anxiety and PTSD. [2023]Lifestyle medicine is a new paradigm that shifts much of the responsibility toward the patient. There is increasing evidence that healthy lifestyle interventions can be effective treatment adjuncts for some of the most common mental illnesses. This article gives examples of how to integrate evidence-based, healthy lifestyle interventions into the overall treatment of common psychiatric conditions, including anxiety and posttraumatic stress disorder (PTSD).
Intensive lifestyle modification: impact on cardiovascular disease risk factors in subjects with and without clinical cardiovascular disease. [2019]Intensive lifestyle modification programs are intended to stabilize or promote regression of coronary artery disease; however, clinical response is often nonuniform, complicating appropriate utilization of resources and prediction of outcome. This study assessed physiological and psychological benefits to 72 persons participating in a prospective, nonrandomized, four-component lifestyle change program and compared response between patients with clinical cardiovascular disease (CVD) and patients with elevated risk factors for CVD but without clinical manifestations of disease. Subjects entering the program due to elevated risk factor levels alone demonstrated equal or greater benefit, in terms of improvement in primary CVD risk factors and reduction in measures of coronary disease risk developed in the Framingham Heart Study, than those with clinical CVD. These findings suggest that intensive lifestyle change programs may be important for primary prevention in individuals at increased risk of CVD.
Effects of lifestyle modification programs on cardiac risk factors. [2020]Medicare conducted a payment demonstration to evaluate the effectiveness of two intensive lifestyle modification programs in patients with symptomatic coronary artery disease: the Dr. Dean Ornish Program for Reversing Heart Disease (Ornish) and Cardiac Wellness Program of the Benson-Henry Mind Body Institute. This report describes the changes in cardiac risk factors achieved by each program during the active intervention year and subsequent year of follow-up. The demonstration enrolled 580 participants who had had an acute myocardial infarction, had undergone coronary artery bypass graft surgery or percutaneous coronary intervention within 12 months, or had documented stable angina pectoris. Of these, 98% completed the intense 3-month intervention, 71% the 12-month intervention, and 56% an additional follow-up year. Most cardiac risk factors improved significantly during the intense intervention period in both programs. Favorable changes in cardiac risk factors and functional cardiac capacity were maintained or improved further at 12 and 24 months in participants with active follow-up. Multivariable regressions found that risk-factor improvements were positively associated with abnormal baseline values, Ornish program participation for body mass index and systolic blood pressure, and with coronary artery bypass graft surgery. Expressed levels of motivation to lose weight and maintain weight loss were significant independent predictors of sustained weight loss (p = 0.006). Both lifestyle modification programs achieved well-sustained reductions in cardiac risk factors.
[Life style changes in patients with myocardial infarct in the framework of intramural and ambulatory rehabilitation--results of a German pilot study]. [2013]To assess whether German patients would make comprehensive lifestyle changes as designed and successfully tested in the San Francisco Lifestyle Heart Trial, we recruited 25 patients who received usual care, and 15 patients who made lifestyle changes during a 6-week in-hospital rehabilitation program followed by a 3-month ambulatory period. The intervention program consisted of a low-fat vegetarian diet, stress management techniques, aerobic exercises, and group support meetings. The program was well accepted, and high compliance resulted in significant changes in the patients' diet, stress management, and exercise activity. For instance, fat intake dropped from 36% to 9% of total calories. As patients in both groups received 20 mg/day of Pravastatin, a lipid-lowering drug, lipid levels dropped significantly in both groups (30% in the intervention group and 27% in the control group). Thus, the combined effect of behavioral and drug treatment did not result in a substantial additional lipid-lowering effect. Within the intervention group significant improvement in quality of life occurred. In conclusion, the lifestyle heart program can be successfully implemented in a German rehabilitation setting which combines in-hospital and out-patient activities. However, participation in the current program is limited to highly motivated, well educated coronary patients.
Multifactorial evaluation of a program for lifestyle behavior change in rehabilitation and secondary prevention of coronary artery disease. [2019]A comprehensive, multifactorial lifestyle behavior change program was developed for rehabilitation and secondary prevention of subjects with coronary artery disease. The purpose of the present report is to describe this intervention model and to analyze results achieved in a first group of consecutive participants. Main inclusion criteria for the 292 subjects were a recent history of acute myocardial infarction, coronary artery bypass surgery, or percutaneous transluminal coronary angioplasty. The program commenced with a 4-week residential stay, with the focus on health education and the achievement of behavior change in major lifestyle areas. During the year of follow-up a systematic maintenance program included regular contact with a nurse. Morbidity and mortality was low. Self-reported quality of life improved and there were significant improvements in blood lipids, exercise capacity and body mass index. There were also significant changes both in psychological variables such as Type A behavior, anger, hostility, and in major lifestyle areas such as stress reactions, diet, exercise and smoking. These changes compared favorably with data from relevant samples from the Swedish normal population. This program had a considerable effect on a number of important factors for rehabilitation and secondary prevention of coronary artery disease.
Long-term effects of lifestyle changes on well-being and cardiac variables among coronary heart disease patients. [2022]To focus on psychological well-being in the Lifestyle Heart Trial (LHT), an intensive lifestyle intervention including diet, exercise, stress management, and group support that previously demonstrated maintenance of comprehensive lifestyle changes and reversal of coronary artery stenosis at 1 and 5 years.