Trial Outcomes & Findings for The Effect of Reducing Posttraumatic Stress Disorder Symptoms on Cardiovascular Risk (NCT NCT02736929)

NCT ID: NCT02736929

Last Updated: 2024-04-17

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 112 participants
• Primary outcome timeframe: Baseline & post-intervention (up to 20 weeks)
• Results posted on: 2024-04-17

Participant Flow

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.

Participant milestones

Measure	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).	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.	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.
Main Study STARTED	78	34	0
Main Study COMPLETED	70	32	0
Main Study NOT COMPLETED	8	2	0
Optional Cross-Over STARTED	0	0	27
Optional Cross-Over COMPLETED	0	0	21
Optional Cross-Over NOT COMPLETED	0	0	6

Reasons for withdrawal

Measure	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).	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.	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.
Main Study Lost to Follow-up	7	1	0
Main Study Withdrawal by Subject	1	1	0
Optional Cross-Over Withdrawal by Subject	0	0	6

Baseline Characteristics

The Effect of Reducing Posttraumatic Stress Disorder Symptoms on Cardiovascular Risk

Baseline characteristics by cohort

Measure	Cognitive Processing Therapy - Cognitive n=78 Participants 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).	Waiting Period Control (WP-CON) n=34 Participants 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.	Total n=112 Participants Total of all reporting groups
Age, Continuous	51.59 years STANDARD_DEVIATION 6.78 • n=5 Participants	52.68 years STANDARD_DEVIATION 6.34 • n=7 Participants	51.92 years STANDARD_DEVIATION 6.64 • n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants	19 Participants n=7 Participants	63 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants	15 Participants n=7 Participants	49 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	76 Participants n=5 Participants	33 Participants n=7 Participants	109 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	45 Participants n=5 Participants	23 Participants n=7 Participants	68 Participants n=5 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants	9 Participants n=7 Participants	35 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	78 Participants n=5 Participants	34 Participants n=7 Participants	112 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline & post-intervention (up to 20 weeks)

Population: 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).

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.

Outcome measures

Measure	Cognitive Processing Therapy - Cognitive n=74 Participants 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).	Waiting Period Control (WP-CON) n=34 Participants 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.
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) Baseline	118 milliseconds Standard Deviation 42	113 milliseconds Standard Deviation 38
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) Post-intervention	123 milliseconds Standard Deviation 45	108 milliseconds Standard Deviation 36

SECONDARY outcome

Timeframe: Baseline & post-intervention (up to 20 weeks)

Population: 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).

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.

Outcome measures

Measure	Cognitive Processing Therapy - Cognitive n=74 Participants 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).	Waiting Period Control (WP-CON) n=34 Participants 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.
Change From Baseline to Post-Intervention in 24-hour Heart Rate Variability (HRV) Estimated From Low Frequency HRV (LF-HRV) Baseline	5.9 ln msec2 Standard Deviation 1.1	5.9 ln msec2 Standard Deviation 1.0
Change From Baseline to Post-Intervention in 24-hour Heart Rate Variability (HRV) Estimated From Low Frequency HRV (LF-HRV) Post-intervention	5.9 ln msec2 Standard Deviation 1.1	5.7 ln msec2 Standard Deviation 1.0

SECONDARY outcome

Timeframe: Baseline & post-intervention (up to 20 weeks)

Population: 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).

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.

Outcome measures

Measure	Cognitive Processing Therapy - Cognitive n=74 Participants 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).	Waiting Period Control (WP-CON) n=34 Participants 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.
Change in Heart Rate Variability (HRV) Measured by Holter Monitor, as Indicated by High Frequency HRV (HF-HRV) Baseline	4.9 ln msec2 Standard Deviation 1.1	5.0 ln msec2 Standard Deviation 1.1
Change in Heart Rate Variability (HRV) Measured by Holter Monitor, as Indicated by High Frequency HRV (HF-HRV) Post-intervention	5.0 ln msec2 Standard Deviation 1.1	4.8 ln msec2 Standard Deviation 1.1

SECONDARY outcome

Timeframe: Baseline & post-intervention (up to 20 weeks)

Population: 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).

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.

Outcome measures

Measure	Cognitive Processing Therapy - Cognitive n=74 Participants 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).	Waiting Period Control (WP-CON) n=34 Participants 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.
Change in Heart Rate Variability (HRV) as Measured by Root Square Mean of Successive Interbeat Interval Differences (RMSSD) Baseline	23.3 milliseconds Standard Deviation 9.9	24.7 milliseconds Standard Deviation 12.5
Change in Heart Rate Variability (HRV) as Measured by Root Square Mean of Successive Interbeat Interval Differences (RMSSD) 6-week follow-up	24.3 milliseconds Standard Deviation 12.9	22.1 milliseconds Standard Deviation 10.8

SECONDARY outcome

Timeframe: Baseline & post-intervention (up to 20 weeks)

Population: 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)

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.

Outcome measures

Measure	Cognitive Processing Therapy - Cognitive n=78 Participants 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).	Waiting Period Control (WP-CON) n=33 Participants 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.
Change From Baseline to Post-Intervention in 24-hour Urinary Excretion of Norepinephrine Baseline	36.3 nanograms per milligram Standard Deviation 16.0	39.8 nanograms per milligram Standard Deviation 22.8
Change From Baseline to Post-Intervention in 24-hour Urinary Excretion of Norepinephrine Post-intervention	33.6 nanograms per milligram Standard Deviation 15.0	38.6 nanograms per milligram Standard Deviation 17.4

SECONDARY outcome

Timeframe: Baseline & post-intervention (up to 20 weeks)

Population: 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)

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.

Outcome measures

Measure	Cognitive Processing Therapy - Cognitive n=78 Participants 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).	Waiting Period Control (WP-CON) n=33 Participants 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.
Change From Baseline to Post-Intervention in 24-hour Urinary Excretion of Epinephrine Baseline	4.4 nanograms per milligram Standard Deviation 3.2	5.0 nanograms per milligram Standard Deviation 3.5
Change From Baseline to Post-Intervention in 24-hour Urinary Excretion of Epinephrine Post-intervention	3.3 nanograms per milligram Standard Deviation 2.1	3.9 nanograms per milligram Standard Deviation 2.0

SECONDARY outcome

Timeframe: Baseline & post-intervention (up to 20 weeks)

Population: 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)

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.

Outcome measures

Measure	Cognitive Processing Therapy - Cognitive n=74 Participants 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).	Waiting Period Control (WP-CON) n=33 Participants 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.
Change From Baseline to Post-Intervention in High Sensitivity C-Reactive Protein (Hs-CRP) Baseline	4.0 milligrams per liter Standard Deviation 6.4	3.6 milligrams per liter Standard Deviation 3.7
Change From Baseline to Post-Intervention in High Sensitivity C-Reactive Protein (Hs-CRP) Post-intervention	3.9 milligrams per liter Standard Deviation 5.8	3.9 milligrams per liter Standard Deviation 5.8

SECONDARY outcome

Timeframe: Baseline & post-intervention (up to 20 weeks)

Population: 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).

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.

Outcome measures

Measure	Cognitive Processing Therapy - Cognitive n=78 Participants 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).	Waiting Period Control (WP-CON) n=34 Participants 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.
Change From Baseline to Post-Intervention in Flow-Mediated Dilation (FMD) Baseline	2.5 percent change Standard Deviation 3.4	3.6 percent change Standard Deviation 3.8
Change From Baseline to Post-Intervention in Flow-Mediated Dilation (FMD) Post-intervention	3.4 percent change Standard Deviation 3.9	3.7 percent change Standard Deviation 4.2

POST_HOC outcome

Timeframe: Baseline & post-intervention (up to 20 weeks)

Population: Subgroup of participants with no history of diabetes.

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.

Outcome measures

Measure	Cognitive Processing Therapy - Cognitive n=61 Participants 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).	Waiting Period Control (WP-CON) n=26 Participants 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.
Change From Baseline to Post-Intervention in Fasting Plasma Insulin Baseline	15.4 uIU/mL Standard Deviation 13.2	14.0 uIU/mL Standard Deviation 9.4
Change From Baseline to Post-Intervention in Fasting Plasma Insulin Post-intervention	11.6 uIU/mL Standard Deviation 7.0	19.3 uIU/mL Standard Deviation 17.5

POST_HOC outcome

Timeframe: Baseline & post-intervention (up to 20 weeks)

Population: Subgroup of participants with no history of diabetes.

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.

Outcome measures

Measure	Cognitive Processing Therapy - Cognitive n=61 Participants 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).	Waiting Period Control (WP-CON) n=26 Participants 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.
Change From Baseline to Post-Intervention in Fasting Plasma Glucose Baseline	88.3 mg/dL Standard Deviation 12.0	87.7 mg/dL Standard Deviation 12.0
Change From Baseline to Post-Intervention in Fasting Plasma Glucose Post-intervention	88.2 mg/dL Standard Deviation 13.3	90.9 mg/dL Standard Deviation 13.2

Adverse Events

Cognitive Processing Therapy - Cognitive

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Waiting Period Control (WP-CON)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

CPT-C After WP-CON

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cognitive Processing Therapy - Cognitive n=78 participants at risk 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).	Waiting Period Control (WP-CON) n=34 participants at risk 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.	CPT-C After WP-CON n=27 participants at risk 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.
Psychiatric disorders hospitalization due to self-harm	1.3% 1/78 • Number of events 1 • Up to 20 weeks	0.00% 0/34 • Up to 20 weeks	0.00% 0/27 • Up to 20 weeks

Other adverse events

Measure	Cognitive Processing Therapy - Cognitive n=78 participants at risk 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).	Waiting Period Control (WP-CON) n=34 participants at risk 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.	CPT-C After WP-CON n=27 participants at risk 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.
Psychiatric disorders increased depression or anxiety	9.0% 7/78 • Number of events 9 • Up to 20 weeks	5.9% 2/34 • Number of events 2 • Up to 20 weeks	11.1% 3/27 • Number of events 3 • Up to 20 weeks
Skin and subcutaneous tissue disorders skin rash	7.7% 6/78 • Number of events 6 • Up to 20 weeks	8.8% 3/34 • Number of events 3 • Up to 20 weeks	0.00% 0/27 • Up to 20 weeks
General disorders nausea and lightheadedness due to fasting	0.00% 0/78 • Up to 20 weeks	2.9% 1/34 • Number of events 1 • Up to 20 weeks	0.00% 0/27 • Up to 20 weeks

Additional Information

Angela Kirby

Duke University School of Medicine

Phone: 919-286-0411

Email: angela.kirby@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place