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Some individuals who are exposed to traumatic events experience both psychological and cardiovascular changes that affect their health and well-being. The purpose of this study is to learn more about how reducing the psychological symptoms (such as those that occur with posttraumatic stress disorder, or PTSD) affects cardiovascular systems that regulate heart and blood pressure.
There is a fundamental gap in the understanding of how a diagnosis of post-traumatic stress disorder (PTSD) portends excess risk of coronary heart disease (CHD). This is primarily because of two reasons: (1) the core studies which provide support for an association between PTSD and CHD risk depended on lengthy follow-up periods with no repeat measurement of either PTSD or other related cardiovascular risk factors; (2) PTSD is highly comorbid with both adverse health behaviors and with psychiatric comorbidity that also vary across time and could largely explain the association between PTSD and increased risk of CHD. The long-term goal is to better understand whether there is a direct link between PTSD and CHD risk, as well as to ascertain the role of candidate pathophysiological mechanisms. The study proposed in this application is designed to examine how changes in PTSD symptoms following an established therapeutic intervention (Cognitive Processing Therapy) affect CHD disease pathways in individuals with PTSD. This design will permit an evaluation of the hypothesis that individuals who show significant improvement in PTSD symptoms will also show improvement in CHD risk biomarkers, and individuals who fail to show improvement or show worsening PTSD symptoms, will show no change or worsening in CHD biomarker activity. The study will also provide an evaluation of the role of key stress-related CHD biomarkers as mechanisms underlying the increased CHD risk burden associated with PTSD. Choice of CHD biomarkers focused on the established association of PTSD with chronic activation of stress response systems and includes autonomic nervous system dysregulation, chronic systemic inflammation, and vascular endothelial dysfunction. The proposed research is significant because it is expected to provide knowledge of the role of both the direct impact of PTSD symptoms on CHD risk pathways and the role of these systems as candidate mechanisms underlying the relationship between PTSD and CHD risk. By better defining how PTSD is a risk factor for CHD, as well as identifying the disease pathways involved, the proposed study will help inform strategies for CHD prevention, as well as guide optimal medical management for vulnerable men and women with PTSD, especially in those who refrain or who are refractory to psychiatric treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Processing Therapy - Cognitive | Active Comparator | Cognitive Processing Therapy - Cognitive (CPT-C), is a brief cognitive behavioral treatment for PTSD. CPT-C consists of 2 hours of therapy each week for 6 weeks (i.e., two sessions). |
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| Waiting Period Control (WP-CON) | No Intervention | WP-CON group will receive minimal attention in the form of weekly telephone calls to assess current emotional state and to provide supportive, nondirective, brief counseling if participants report experiencing a crisis. Any participant assigned to the WP-CON group will be given the opportunity to receive CPT-C after the post-waiting period assessment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Processing Therapy - Cognitive | Behavioral | CPT-C is a brief cognitive behavioral treatment for PTSD. It consists of 2 hours of therapy each week for 6 weeks (i.e., two sessions). |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Post-Intervention in 24-hour Heart Rate Variability (HRV) Estimated From the Standard Deviation of the Interbeat Interval of Normal Sinus Beats (SDNN) | 24-hour HRV measured from SDNN was obtained from 24-hours of ambulatory electocardiograph (ECG) recordings. Inclusion criteria for HRV requires that at least 80% of the recording show normal sinus rhythm. SDNN is an independent predictor of coronary heart disease and cardiac death. Means for SDNN are listed below, and evaluation of change in scores can be found in statistical analysis 1. | Baseline & post-intervention (up to 20 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Post-Intervention in 24-hour Heart Rate Variability (HRV) Estimated From Low Frequency HRV (LF-HRV) | 24-hour HRV measured from LF-HRV was obtained from 24-hours of ambulatory electrocardiograph (ECG) recordings. Inclusion criteria for HRV requires that at least 80% of the recording show normal sinus rhythm. LF-HRV is a frequency domain measure of HRV which captures all heart rate variations occurring over the frequency band linked to sympathetic vasomotor oscillations. Higher LF-HRV reflects stronger baroreflex cardiovascular control which is offset by increases in cardiac efferent sympathetic activity during periods of acute stress and physical activity. Low levels of LF-HRV are predictive of incident diabetes and increased coronary heart disease risk. Means for LF-HRV are listed below, and evaluation of change in scores can be found in statistical analysis 1. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lana Watkins, Ph.D. | Duke University | Principal Investigator |
| Jean C. Beckham, Ph.D. | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27706 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33429088 | Derived | LoSavio ST, Beckham JC, Wells SY, Resick PA, Sherwood A, Coffman CJ, Kirby AC, Beaver TA, Dennis MF, Watkins LL. The effect of reducing posttraumatic stress disorder symptoms on cardiovascular risk: Design and methodology of a randomized clinical trial. Contemp Clin Trials. 2021 Mar;102:106269. doi: 10.1016/j.cct.2021.106269. Epub 2021 Jan 8. |
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The total protocol enrollment was 112. Participants assigned to the Waitlist Period Control group were given the option to receive Cognitive Processing Therapy (CPT) after their second assessment. 27 of the 34 control group participants opted to receive CPT.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cognitive Processing Therapy - Cognitive | Cognitive Processing Therapy - Cognitive (CPT-C), is a brief cognitive behavioral treatment for PTSD. CPT-C consists of 2 hours of therapy each week for 6 weeks (i.e., two sessions). Cognitive Processing Therapy - Cognitive: CPT-C is a brief cognitive behavioral treatment for PTSD. It consists of 2 hours of therapy each week for 6 weeks (i.e., two sessions). |
| FG001 | Waiting Period Control (WP-CON) | WP-CON group will receive minimal attention in the form of weekly telephone calls to assess current emotional state and to provide supportive, nondirective, brief counseling if participants report experiencing a crisis. Any participant assigned to the WP-CON group will be given the opportunity to receive CPT-C after the post-waiting period assessment. |
| FG002 | CPT-C After WP-CON | Any participant assigned to the WP-CON group will be given the opportunity to receive CPT-C after the post-waiting period assessment. Participants are not required to participate in this therapy or the study assessments; it is completely voluntary. Any data collected from this group of participants will not be included in primary or secondary outcome analysis. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Main Study |
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| Optional Cross-Over |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cognitive Processing Therapy - Cognitive | Cognitive Processing Therapy - Cognitive (CPT-C), is a brief cognitive behavioral treatment for PTSD. CPT-C consists of 2 hours of therapy each week for 6 weeks (i.e., two sessions). Cognitive Processing Therapy - Cognitive: CPT-C is a brief cognitive behavioral treatment for PTSD. It consists of 2 hours of therapy each week for 6 weeks (i.e., two sessions). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to Post-Intervention in 24-hour Heart Rate Variability (HRV) Estimated From the Standard Deviation of the Interbeat Interval of Normal Sinus Beats (SDNN) | 24-hour HRV measured from SDNN was obtained from 24-hours of ambulatory electocardiograph (ECG) recordings. Inclusion criteria for HRV requires that at least 80% of the recording show normal sinus rhythm. SDNN is an independent predictor of coronary heart disease and cardiac death. Means for SDNN are listed below, and evaluation of change in scores can be found in statistical analysis 1. | At baseline in the CPT group, 3 participants had unusable HRV based on HRV inclusion criteria and 1 participant had an allergic reaction requiring early removal of the recorder. Imputation was used to impute outcomes for the post-intervention missing data (11 drop-outs (9 in the CPT group and 2 in the WP-CON group) and 2 additional participants in the CPT refused to wear the recorder post-intervention (one of which experienced the allergic reaction at baseline). | Posted | Mean | Standard Deviation | milliseconds | Baseline & post-intervention (up to 20 weeks) |
|
Up to 20 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cognitive Processing Therapy - Cognitive | Cognitive Processing Therapy - Cognitive (CPT-C), is a brief cognitive behavioral treatment for PTSD. CPT-C consists of 2 hours of therapy each week for 6 weeks (i.e., two sessions). Cognitive Processing Therapy - Cognitive: CPT-C is a brief cognitive behavioral treatment for PTSD. It consists of 2 hours of therapy each week for 6 weeks (i.e., two sessions). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hospitalization due to self-harm | Psychiatric disorders | Non-systematic Assessment | Pt. was hospitalized overnight after cutting herself. Pt. had a pre-existing history of nonsuicidal self injury. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| increased depression or anxiety | Psychiatric disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Angela Kirby | Duke University School of Medicine | 919-286-0411 | 175526 | angela.kirby@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 12, 2021 | Jul 7, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 4, 2021 | Jul 7, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| Baseline & post-intervention (up to 20 weeks) |
| Change in Heart Rate Variability (HRV) Measured by Holter Monitor, as Indicated by High Frequency HRV (HF-HRV) | 24-hour HRV measured from HF-HRV was obtained from 24-hours of ambulatory electocardiograph (ECG) recordings. Inclusion criteria for HRV requires that at least 80% of the recording show normal sinus rhythm. HF-HRV is a frequency domain measure of HRV which captures all heart rate variations occurring over the frequency band linked to respiration. Higher HF-HRV reflects stronger parasympathetic cardiac control. Low levels of HF-HRV are predictive of increased coronary heart disease risk. Means for HF-HRV are listed below, and evaluation of change in scores can be found in statistical analysis 1. | Baseline & post-intervention (up to 20 weeks) |
| Change in Heart Rate Variability (HRV) as Measured by Root Square Mean of Successive Interbeat Interval Differences (RMSSD) | 24-hour HRV measured from RMSSD was obtained from 24-hours of ambulatory electocardiograph (ECG) recordings. Inclusion criteria for HRV requires that at least 80% of the recording show normal sinus rhythm. RMSSD is a time domain measure of HRV which captures heart rate variations occurring over the frequency band linked to respiration. Higher RMSSD reflects stronger parasympathetic cardiac control. Means for RMSSD are listed below, and evaluation of change in scores can be found in statistical analysis 1. | Baseline & post-intervention (up to 20 weeks) |
| Change From Baseline to Post-Intervention in 24-hour Urinary Excretion of Norepinephrine | 24-hour urinary excretion of norepinephrine was obtained from 24-hours of urine collection. Inclusion criteria for 24-hour urine collection requires that at least 300 milliliters of urine be collected. Norepinephrine levels have been found to be elevated in PTSD and following trauma exposure. Norepinephrine is implicated in the association between cardiovascular disease and stress. Means for norepinephrine are listed below, and evaluation of change in scores can be found in statistical analysis 1. | Baseline & post-intervention (up to 20 weeks) |
| Change From Baseline to Post-Intervention in 24-hour Urinary Excretion of Epinephrine | 24-hour urinary excretion of epinephrine was obtained from 24-hours of urine collection. Inclusion criteria for 24-hour urine collection requires that at least 300 milliliters of urine be collected. Epinephrine levels have been found to be elevated in PTSD and following trauma exposure. Epinephrine is implicated in the association between cardiovascular disease and stress. Means for epinephrine are listed below, and evaluation of change in scores can be found in statistical analysis 1. | Baseline & post-intervention (up to 20 weeks) |
| Change From Baseline to Post-Intervention in High Sensitivity C-Reactive Protein (Hs-CRP) | Peripheral inflammation was measured from fasting levels of CRP. Inclusion criteria for measurement of hsCRP requires that the participant be free from active infections or acute inflammatory conditions; therefore, participants were required to be free of fever, infections, and acute inflammatory conditions for a minimum of 7 days prior to the blood draw. Oral temperatures were obtained from all participants to check for sickness at the time of blood draw. CRP will be measured because it has a strong correlation with cardiovascular morbidity and mortality. Means for hs-CRP are listed below, and evaluation of change in scores can be found in statistical analysis 1. | Baseline & post-intervention (up to 20 weeks) |
| Change From Baseline to Post-Intervention in Flow-Mediated Dilation (FMD) | Vascular endothelial function was measured under fasting conditions from the percent change in dilation of the brachial artery following controlled occlusion of the artery. FMD is a measure of health of blood vessels. Lower flow mediated dilation is associated with poor cardiovascular health. FMD was measured because it has been correlated with cardiovascular morbidity and mortality and is reduced following trauma exposure. Means for FMD are listed below, and evaluation of change in scores can be found in statistical analysis 1. | Baseline & post-intervention (up to 20 weeks) |
| NOT COMPLETED |
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| BG001 | Waiting Period Control (WP-CON) | WP-CON group will receive minimal attention in the form of weekly telephone calls to assess current emotional state and to provide supportive, nondirective, brief counseling if participants report experiencing a crisis. Any participant assigned to the WP-CON group will be given the opportunity to receive CPT-C after the post-waiting period assessment. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Description |
|---|
| OG000 | Cognitive Processing Therapy - Cognitive | Cognitive Processing Therapy - Cognitive (CPT-C), is a brief cognitive behavioral treatment for PTSD. CPT-C consists of 2 hours of therapy each week for 6 weeks (i.e., two sessions). Cognitive Processing Therapy - Cognitive: CPT-C is a brief cognitive behavioral treatment for PTSD. It consists of 2 hours of therapy each week for 6 weeks (i.e., two sessions). |
| OG001 | Waiting Period Control (WP-CON) | WP-CON group will receive minimal attention in the form of weekly telephone calls to assess current emotional state and to provide supportive, nondirective, brief counseling if participants report experiencing a crisis. Any participant assigned to the WP-CON group will be given the opportunity to receive CPT-C after the post-waiting period assessment. |
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| Secondary | Change From Baseline to Post-Intervention in 24-hour Heart Rate Variability (HRV) Estimated From Low Frequency HRV (LF-HRV) | 24-hour HRV measured from LF-HRV was obtained from 24-hours of ambulatory electrocardiograph (ECG) recordings. Inclusion criteria for HRV requires that at least 80% of the recording show normal sinus rhythm. LF-HRV is a frequency domain measure of HRV which captures all heart rate variations occurring over the frequency band linked to sympathetic vasomotor oscillations. Higher LF-HRV reflects stronger baroreflex cardiovascular control which is offset by increases in cardiac efferent sympathetic activity during periods of acute stress and physical activity. Low levels of LF-HRV are predictive of incident diabetes and increased coronary heart disease risk. Means for LF-HRV are listed below, and evaluation of change in scores can be found in statistical analysis 1. | At baseline in the CPT group, 3 participants had unusable HRV based on HRV inclusion criteria and 1 participant had an allergic reaction requiring early removal of the recorder. Imputation was used to impute outcomes for the post-intervention missing data (11 drop-outs (9 in the CPT group and 2 in the WP-CON group) and 2 additional participants in the CPT refused to wear the recorder post-intervention (one of which experienced the allergic reaction at baseline). | Posted | Mean | Standard Deviation | ln msec2 | Baseline & post-intervention (up to 20 weeks) |
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| Secondary | Change in Heart Rate Variability (HRV) Measured by Holter Monitor, as Indicated by High Frequency HRV (HF-HRV) | 24-hour HRV measured from HF-HRV was obtained from 24-hours of ambulatory electocardiograph (ECG) recordings. Inclusion criteria for HRV requires that at least 80% of the recording show normal sinus rhythm. HF-HRV is a frequency domain measure of HRV which captures all heart rate variations occurring over the frequency band linked to respiration. Higher HF-HRV reflects stronger parasympathetic cardiac control. Low levels of HF-HRV are predictive of increased coronary heart disease risk. Means for HF-HRV are listed below, and evaluation of change in scores can be found in statistical analysis 1. | At baseline in the CPT group, 3 participants had unusable HRV based on HRV inclusion criteria and 1 participant had an allergic reaction requiring early removal of the recorder. Imputation was used to impute outcomes for the post-intervention missing data (11 drop-outs (9 in the CPT group and 2 in the WP-CON group) and 2 additional participants in the CPT refused to wear the recorder post-intervention (one of which experienced the allergic reaction at baseline). | Posted | Mean | Standard Deviation | ln msec2 | Baseline & post-intervention (up to 20 weeks) |
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| Secondary | Change in Heart Rate Variability (HRV) as Measured by Root Square Mean of Successive Interbeat Interval Differences (RMSSD) | 24-hour HRV measured from RMSSD was obtained from 24-hours of ambulatory electocardiograph (ECG) recordings. Inclusion criteria for HRV requires that at least 80% of the recording show normal sinus rhythm. RMSSD is a time domain measure of HRV which captures heart rate variations occurring over the frequency band linked to respiration. Higher RMSSD reflects stronger parasympathetic cardiac control. Means for RMSSD are listed below, and evaluation of change in scores can be found in statistical analysis 1. | At baseline in the CPT group, 3 participants had unusable HRV based on HRV inclusion criteria and 1 participant had an allergic reaction requiring early removal of the recorder. Imputation was used to impute outcomes for the post-intervention missing data (11 drop-outs (9 in the CPT group and 2 in the WP-CON group) and 2 additional participants in the CPT refused to wear the recorder post-intervention (one of which experienced the allergic reaction at baseline). | Posted | Mean | Standard Deviation | milliseconds | Baseline & post-intervention (up to 20 weeks) |
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| Secondary | Change From Baseline to Post-Intervention in 24-hour Urinary Excretion of Norepinephrine | 24-hour urinary excretion of norepinephrine was obtained from 24-hours of urine collection. Inclusion criteria for 24-hour urine collection requires that at least 300 milliliters of urine be collected. Norepinephrine levels have been found to be elevated in PTSD and following trauma exposure. Norepinephrine is implicated in the association between cardiovascular disease and stress. Means for norepinephrine are listed below, and evaluation of change in scores can be found in statistical analysis 1. | At baseline in the WP-CON group, 1 participant had unusable urinary norepinephrine based on the 24-hour urine inclusion criteria. Imputation was used to impute the missing data from the the 14 participants who did not have post-intervention data either due to dropping out of the study (8 in the CPT group and 2 in the WP-CON group), due to technical problems with sample analysis (n=2), failure to meet inclusion criteria for urine collection (n=1) or refusal to collect urine (n=1) | Posted | Mean | Standard Deviation | nanograms per milligram | Baseline & post-intervention (up to 20 weeks) |
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| Secondary | Change From Baseline to Post-Intervention in 24-hour Urinary Excretion of Epinephrine | 24-hour urinary excretion of epinephrine was obtained from 24-hours of urine collection. Inclusion criteria for 24-hour urine collection requires that at least 300 milliliters of urine be collected. Epinephrine levels have been found to be elevated in PTSD and following trauma exposure. Epinephrine is implicated in the association between cardiovascular disease and stress. Means for epinephrine are listed below, and evaluation of change in scores can be found in statistical analysis 1. | At baseline in the WP-CON group, 1 participant had unusable urinary norepinephrine based on the 24-hour urine inclusion criteria. Imputation was used to impute the missing data from the 14 participants who did not have post-intervention data due to either dropping out of the study (8 in the CPT group and 2 in the WP-CON group), due to technical problems with sample analysis (n=2), failure to meet inclusion criteria for urine collection (n=1) or refusal to collect urine (n=1) | Posted | Mean | Standard Deviation | nanograms per milligram | Baseline & post-intervention (up to 20 weeks) |
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| Secondary | Change From Baseline to Post-Intervention in High Sensitivity C-Reactive Protein (Hs-CRP) | Peripheral inflammation was measured from fasting levels of CRP. Inclusion criteria for measurement of hsCRP requires that the participant be free from active infections or acute inflammatory conditions; therefore, participants were required to be free of fever, infections, and acute inflammatory conditions for a minimum of 7 days prior to the blood draw. Oral temperatures were obtained from all participants to check for sickness at the time of blood draw. CRP will be measured because it has a strong correlation with cardiovascular morbidity and mortality. Means for hs-CRP are listed below, and evaluation of change in scores can be found in statistical analysis 1. | At baseline in the CPT group, 3 participants reported infections which violated protocol criteria and 1 sample was not analyzed due to technical problems. At baseline in the WP-CON group, 1 participant refused blood draw. Imputation was used to impute the missing data from the 17 participants who either dropped out (9 in the CPT group and 2 in the WL-CON group), had infection (1 in the CPT group), experienced technical problems (4 in the CPT group), or refused (1 in the WP-CON group) | Posted | Mean | Standard Deviation | milligrams per liter | Baseline & post-intervention (up to 20 weeks) |
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| Secondary | Change From Baseline to Post-Intervention in Flow-Mediated Dilation (FMD) | Vascular endothelial function was measured under fasting conditions from the percent change in dilation of the brachial artery following controlled occlusion of the artery. FMD is a measure of health of blood vessels. Lower flow mediated dilation is associated with poor cardiovascular health. FMD was measured because it has been correlated with cardiovascular morbidity and mortality and is reduced following trauma exposure. Means for FMD are listed below, and evaluation of change in scores can be found in statistical analysis 1. | Imputation was used to impute data from the 11 participants who were missing post-intervention data due to dropping out of the study (9 in the CPT group and 2 in the WL-CON group). | Posted | Mean | Standard Deviation | percent change | Baseline & post-intervention (up to 20 weeks) |
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| Post-Hoc | Change From Baseline to Post-Intervention in Fasting Plasma Insulin | Fasting plasma insulin is a measure of insulin resistance and is a independent predictor of cardiovascular mortality and of autonomic neuropathy. PTSD has been associated with increased incidence of diabetes and metabolic dysfunction. Means for fasting insulin are listed below, and evaluation of change in scores can be found in statistical analysis 1. | Subgroup of participants with no history of diabetes. | Posted | Mean | Standard Deviation | uIU/mL | Baseline & post-intervention (up to 20 weeks) |
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| Post-Hoc | Change From Baseline to Post-Intervention in Fasting Plasma Glucose | Fasting plasma glucose is a measure of diabetes risk and is a independent predictor of cardiovascular mortality and of autonomic neuropathy. PTSD has been associated with increased incidence of diabetes and metabolic dysfunction. Means for fasting glucose are listed below, and evaluation of change in scores can be found in statistical analysis 1. | Subgroup of participants with no history of diabetes. | Posted | Mean | Standard Deviation | mg/dL | Baseline & post-intervention (up to 20 weeks) |
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| 0 |
| 78 |
| 1 |
| 78 |
| 13 |
| 78 |
| EG001 | Waiting Period Control (WP-CON) | WP-CON group will receive minimal attention in the form of weekly telephone calls to assess current emotional state and to provide supportive, nondirective, brief counseling if participants report experiencing a crisis. Any participant assigned to the WP-CON group will be given the opportunity to receive CPT-C after the post-waiting period assessment. | 0 | 34 | 0 | 34 | 6 | 34 |
| EG002 | CPT-C After WP-CON | Any participant assigned to the WP-CON group will be given the opportunity to receive CPT-C after the post-waiting period assessment. Participants are not required to participate in this therapy or the study assessments; it is completely voluntary. Any data collected from this group of participants will not be included in primary or secondary outcome analysis. | 0 | 27 | 0 | 27 | 3 | 27 |
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| skin rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Related to wearing electrodes |
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| nausea and lightheadedness due to fasting | General disorders | Non-systematic Assessment |
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