Comparative Effectiveness Research in Veterans With PTSD (CERV-PTSD)

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ClinicalTrials.gov Identifier: NCT01928732

Recruitment Status : Completed

First Posted : August 27, 2013

Results First Posted : January 26, 2022

Last Update Posted : February 2, 2022

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

VA Office of Research and Development

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
Condition	Post-Traumatic Stress Disorder
Interventions	Behavioral: Cognitive Processing Therapy (CPT) Behavioral: Prolonged Exposure (PE)
Enrollment	916

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Behavioral: Prolonged Exposure (PE)	Behavioral: Cognitive Processing Therapy (CPT)
Arm/Group Description	PE is a manualized, 90-minute, 8-15...	CPT consists of cognitive therapy a...
Arm/Group Description	PE is a manualized, 90-minute, 8-15 week treatment program based on emotional processing theory, which posits that anxiety disorders, including PTSD, reflect pathological fear structures in which emotional and cognitive associations among different elements do not accurately represent reality and renders the individual dysfunctional and distressed. PE is designed to correct erroneous connections in the targeted memory structure. PTSD sufferers typically experience two key pathological emotional response sets and related cognitions: "The world is an utterly dangerous place," and "I am completely incompetent and unable to cope with stress." In this study, the 12-session protocol will be followed, but participants improve more rapidly may finish in 10 sessions and those who improve more slowly may have up to 2 additional sessions to continue working on exposure.	CPT consists of cognitive therapy and a written trauma narrative. Patients are taught to challenge their beliefs through Socratic questioning and the use of daily worksheets. The initial focus is on beliefs such as denial and self-blame, and then shifts to overgeneralized beliefs about self and the world. Patients process their trauma directly by writing a narrative of their traumatic event(s) that they read to themselves and to therapists. The typical protocol consists of 12 1-hr sessions. In this study, the 12-session protocol will be followed, but participants who improve more rapidly may finish in 10 sessions and those who improve more slowly may receive up to 2 additional sessions to continue working on stuck points with challenging beliefs worksheets.
Period Title: Overall Study
Started	455	461
Completed	326	334
Not Completed	129	127

Baseline Characteristics

Arm/Group Title		Behavioral: Prolonged Exposure (PE)	Behavioral: Cognitive Processing Therapy (CPT)	Total
Arm/Group Description		PE is a manualized, 90-minute, 8-15...	CPT consists of cognitive therapy a...	Total of all reporting groups
Arm/Group Description		PE is a manualized, 90-minute, 8-15 week treatment program based on emotional processing theory, which posits that anxiety disorders, including PTSD, reflect pathological fear structures in which emotional and cognitive associations among different elements do not accurately represent reality and renders the individual dysfunctional and distressed. PE is designed to correct erroneous connections in the targeted memory structure. PTSD sufferers typically experience two key pathological emotional response sets and related cognitions: "The world is an utterly dangerous place," and "I am completely incompetent and unable to cope with stress." In this study, the 12-session protocol will be followed, but participants improve more rapidly may finish in 10 sessions and those who improve more slowly may have up to 2 additional sessions to continue working on exposure.	CPT consists of cognitive therapy and a written trauma narrative. Patients are taught to challenge their beliefs through Socratic questioning and the use of daily worksheets. The initial focus is on beliefs such as denial and self-blame, and then shifts to overgeneralized beliefs about self and the world. Patients process their trauma directly by writing a narrative of their traumatic event(s) that they read to themselves and to therapists. The typical protocol consists of 12 1-hr sessions. In this study, the 12-session protocol will be followed, but participants who improve more rapidly may finish in 10 sessions and those who improve more slowly may receive up to 2 additional sessions to continue working on stuck points with challenging beliefs worksheets.	Total of all reporting groups
Overall Number of Baseline Participants		455	461	916
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Mean (Full Range) Unit of measure: Years
	Number Analyzed	455 participants	461 participants	916 participants
		45.5 (44.3 to 46.8)	44.9 (43.7 to 46.1)	45.2 (44.3 to 46.1)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	455 participants	461 participants	916 participants
	Female	94 20.7%	92 20.0%	186 20.3%
	Male	361 79.3%	369 80.0%	730 79.7%
Race/Ethnicity, Customized ^[1] Measure Type: Count of Participants Unit of measure: Participants
White	Number Analyzed	455 participants	461 participants	916 participants
White		301 66.2%	289 62.7%	590 64.4%
Black	Number Analyzed	455 participants	461 participants	916 participants
Black		119 26.2%	130 28.2%	249 27.2%
American Indian/Alaskan Native	Number Analyzed	455 participants	461 participants	916 participants
American Indian/Alaskan Native		18 4.0%	15 3.3%	33 3.6%
Asian	Number Analyzed	455 participants	461 participants	916 participants
Asian		14 3.1%	11 2.4%	25 2.7%
Native Hawaiian/Pacific Islander	Number Analyzed	455 participants	461 participants	916 participants
Native Hawaiian/Pacific Islander		7 1.5%	10 2.2%	17 1.9%
Other	Number Analyzed	455 participants	461 participants	916 participants
Other		21 4.6%	25 5.4%	46 5.0%
		[1] Measure Description: Participants could select multiple categories for "Race."
Service Era ^[1] Measure Type: Count of Participants Unit of measure: Participants
Vietnam	Number Analyzed	455 participants	461 participants	916 participants
Vietnam		82 18.0%	77 16.7%	159 17.4%
Gulf War	Number Analyzed	455 participants	461 participants	916 participants
Gulf War		85 18.7%	87 18.9%	172 18.8%
OEF/OIF/OND	Number Analyzed	455 participants	461 participants	916 participants
OEF/OIF/OND		260 57.1%	270 58.6%	530 57.9%
Other	Number Analyzed	455 participants	461 participants	916 participants
Other		66 14.5%	59 12.8%	125 13.6%
		[1] Measure Description: Service era was coded by including any Vietnam, Gulf, or OEF/OIF/OND veteran in their respective categories (including if they served in more than one era, e.g., Vietnam and Gulf). If a veteran did not serve in Vietnam, Gulf, or OEF/OIF/OND, they were coded as "Other."
Post-high school education Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	455 participants	461 participants	916 participants
		216 47.5%	192 41.6%	408 44.5%
Unemployed Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	455 participants	461 participants	916 participants
		271 59.6%	263 57.0%	534 58.3%
Married/cohabitating Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	455 participants	461 participants	916 participants
		246 54.1%	237 51.4%	483 52.7%
Ethnicity: Spanish, Hispanic or Latino Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	455 participants	461 participants	916 participants
		67 14.7%	72 15.6%	139 15.2%
Positive VA Military Sexual Trauma Screen Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	455 participants	461 participants	916 participants
		134 29.5%	133 28.9%	267 29.1%
Positive VA Traumatic Brain Injury Screen Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	455 participants	461 participants	916 participants
		294 64.6%	281 61.0%	575 62.8%
Lifetime trauma exposure: Number of event types (of 17) Mean (Full Range) Unit of measure: Number of event types
	Number Analyzed	455 participants	461 participants	916 participants
		7.7 (7.4 to 7.9)	7.4 (7.2 to 7.7)	7.54 (7.4 to 7.7)
Lifetime trauma exposure Measure Type: Count of Participants Unit of measure: Participants
Combat exposure	Number Analyzed	455 participants	461 participants	916 participants
Combat exposure		357 78.5%	347 75.3%	704 76.9%
Any sexual trauma	Number Analyzed	455 participants	461 participants	916 participants
Any sexual trauma		166 36.5%	163 35.4%	329 35.9%
Physical assault	Number Analyzed	455 participants	461 participants	916 participants
Physical assault		386 84.8%	408 88.5%	794 86.7%
Disaster exposure	Number Analyzed	455 participants	461 participants	916 participants
Disaster exposure		391 85.9%	385 83.5%	776 84.7%
Serious accident	Number Analyzed	455 participants	461 participants	916 participants
Serious accident		385 84.6%	389 84.4%	774 84.5%
Life-threatening illness or injury	Number Analyzed	455 participants	461 participants	916 participants
Life-threatening illness or injury		154 33.8%	163 35.4%	317 34.6%
Other traumatic event	Number Analyzed	455 participants	461 participants	916 participants
Other traumatic event		371 81.5%	354 76.8%	725 79.1%
PTSD disability ^[1] [2] Measure Type: Count of Participants Unit of measure: Participants
Approved	Number Analyzed	453 participants	459 participants	912 participants
Approved		186 41.1%	202 44.0%	388 42.5%
Pending	Number Analyzed	453 participants	459 participants	912 participants
Pending		116 25.6%	129 28.1%	245 26.9%
Denied	Number Analyzed	453 participants	459 participants	912 participants
Denied		26 5.7%	19 4.1%	45 4.9%
Never applied	Number Analyzed	453 participants	459 participants	912 participants
Never applied		125 27.6%	109 23.7%	234 25.7%
		[1] Measure Description: Two participants in the PE group and two participants in the CPT group did not report their "PTSD Disability" status. [2] Measure Analysis Population Description: Two participants in the PE group and two participants in the CPT group did not report their "PTSD Disability" status.
Receiving psychotherapy Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	455 participants	461 participants	916 participants
		95 20.9%	98 21.3%	193 21.1%
Taking psychotropic medication Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	455 participants	461 participants	916 participants
		303 66.6%	317 68.8%	620 67.7%
Any current comorbid psychiatric disorder Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	455 participants	461 participants	916 participants
		343 75.4%	371 80.5%	714 77.9%
Any current comorbid psychiatric disorder Measure Type: Count of Participants Unit of measure: Participants
Mood disorder	Number Analyzed	455 participants	461 participants	916 participants
Mood disorder		309 67.9%	332 72.0%	641 70.0%
Anxiety disorder	Number Analyzed	455 participants	461 participants	916 participants
Anxiety disorder		139 30.5%	166 36.0%	305 33.3%
Substance use disorders	Number Analyzed	455 participants	461 participants	916 participants
Substance use disorders		32 7.0%	40 8.7%	72 7.9%
Obsessive compulsive disorder	Number Analyzed	455 participants	461 participants	916 participants
Obsessive compulsive disorder		19 4.2%	29 6.3%	48 5.2%
Any lifetime comorbid psychiatric disorder Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	455 participants	461 participants	916 participants
		417 91.6%	424 92.0%	841 91.8%
Any lifetime comorbid psychiatric disorder Measure Type: Count of Participants Unit of measure: Participants
Mood disorder	Number Analyzed	455 participants	461 participants	916 participants
Mood disorder		398 87.5%	400 86.8%	798 87.1%
Anxiety disorder	Number Analyzed	455 participants	461 participants	916 participants
Anxiety disorder		149 32.7%	181 39.3%	330 36.0%
Substance use disorders	Number Analyzed	455 participants	461 participants	916 participants
Substance use disorders		130 28.6%	112 24.3%	242 26.4%
Obsessive compulsive disorder	Number Analyzed	455 participants	461 participants	916 participants
Obsessive compulsive disorder		24 5.3%	36 7.8%	60 6.6%
Clinician Administered PTSD Scale-5 ^[1] Mean (Full Range) Unit of measure: Score on a scale
	Number Analyzed	455 participants	461 participants	916 participants
		39.9 (39.1 to 40.7)	40.3 (39.5 to 41.1)	40.1 (39.6 to 40.7)
		[1] Measure Description: Possible range for CAPS-5 total score 0-80. Higher score indicates more severe PTSD.
Posttraumatic Diagnostic Scale ^[1] Mean (Full Range) Unit of measure: Score on a scale
	Number Analyzed	455 participants	461 participants	916 participants
		50.7 (49.5 to 52.0)	50.5 (49.3 to 51.7)	50.63 (49.8 to 51.5)
		[1] Measure Description: Possible range for PDS-5 score 0-80. Higher PDS-5 Score indicates more severe PTSD Symptoms.
Beck Depression Inventory-II ^[1] Mean (Full Range) Unit of measure: Score on a scale
	Number Analyzed	455 participants	461 participants	916 participants
		30.3 (29.4 to 31.3)	30.0 (29.0 to 30.9)	30.2 (29.5 to 30.8)
		[1] Measure Description: Possible range for BDI-II 0-63. Higher score indicates more severe depressive symptoms (0-13 minimal, 14-29 mild, 20-28 moderate, 29-63 severe).
Beck Depression Inventory-II Suicidality (BDI-II Item 9) ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	455 participants	461 participants	916 participants
		163 35.8%	156 33.8%	319 34.8%
		[1] Measure Description: Suicidality was coded by grouping "I have thoughts of killing myself, but I would not carry them out" "I would like to kill myself" and "I would kill myself if I had the chance" from item 9 of the BDI-II together as endorsing suicidality. Unit of measure is the #/% of participants who endorsed suicidality using this coding metric.
Spielberger Trait Anger Expression Inventory ^[1] Mean (Full Range) Unit of measure: Score on a scale
State Anger	Number Analyzed	455 participants	461 participants	916 participants
State Anger		17.8 (17.1 to 18.5)	17.9 (17.3 to 18.6)	17.9 (17.4 to 18.3)
Trait Anger	Number Analyzed	455 participants	461 participants	916 participants
Trait Anger		24.1 (23.5 to 24.8)	24.2 (23.6 to 24.8)	24.2 (23.7 to 24.6)
Anger Expression	Number Analyzed	455 participants	461 participants	916 participants
Anger Expression		37.3 (36.3 to 38.3)	36.4 (35.5 to 37.4)	36.9 (36.2 to 37.5)
		[1] Measure Description: Subscale Ranges: State Anger 10-40, Trait Anger 10-40, Anger Expression 0-72. Higher score indicates more anger
Brief Addiction Monitor ^[1] Mean (Full Range) Unit of measure: Score on a scale
	Number Analyzed	455 participants	461 participants	916 participants
		0.8 (0.6 to 0.9)	0.8 (0.7 to 0.9)	0.8 (0.7 to 0.9)
		[1] Measure Description: Range: 0-4 points. Higher score indicates worse outcome (i.e., more severe addiction)
Short Inventory of Problems-Revised ^[1] Mean (Full Range) Unit of measure: Score on a scale
	Number Analyzed	455 participants	461 participants	916 participants
		3.5 (2.7 to 4.3)	3.3 (2.5 to 4.1)	3.4 (2.9 to 4.0)
		[1] Measure Description: Possible range for SIP-R 0-51. Higher score indicates more severe adverse consequences of substance use.
World Health Organization Disability Adjustment Scale-II ^[1] Mean (Full Range) Unit of measure: Score on a scale
	Number Analyzed	455 participants	461 participants	916 participants
		29.4 (28.6 to 30.3)	29.7 (28.9 to 30.5)	29.6 (29.0 to 30.1)
		[1] Measure Description: Possible range for WHODAS-II 12-60. Higher score indicates more difficulty and disability due to health condition.
World Health Organization Quality of Life-BREF ^[1] Mean (Full Range) Unit of measure: Score on a scale
Physical Health	Number Analyzed	455 participants	461 participants	916 participants
Physical Health		44.4 (43.4 to 45.3)	43.7 (42.7 to 44.7)	44.1 (43.4 to 44.8)
Psychological	Number Analyzed	455 participants	461 participants	916 participants
Psychological		46.5 (45.2 to 47.8)	46.4 (45.2 to 47.7)	46.5 (45.6 to 47.4)
Social Relationships	Number Analyzed	455 participants	461 participants	916 participants
Social Relationships		41.3 (39.4 to 43.3)	40.6 (38.7 to 42.5)	41.0 (39.6 to 42.3)
Environment	Number Analyzed	455 participants	461 participants	916 participants
Environment		58.2 (56.6 to 59.7)	57.4 (55.9 to 59.0)	57.8 (56.7 to 58.9)
		[1] Measure Description: Possible range for WHOQOL-BREF 0-100, Physical Health 0-100, Psychological 0-100, Social Relationships 0-100, and Environment 0-100. Higher score indicates better satisfaction with life.
Number of patients preferring PE treatment at baseline ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	455 participants	461 participants	916 participants
		232 51.0%	214 46.4%	446 48.7%
		[1] Measure Description: Treatment preference was assessed at baseline (before any treatment was administered, and before randomization to treatment arm had occurred). This measure is reported as the number of patients who reported a preference for PE as opposed to CPT. All unreported patients reported a preference for CPT (i.e., "no preference" was not a response option and no patients declined to answer).

Outcome Measures

1.Primary Outcome


Title	Change in PTSD Symptom Severity on the Clinician-Administered PTSD Scale (CAPS)
Description	The primary outcome is the change of CAPS-5 total score from baseline ...
Description	The primary outcome is the change of CAPS-5 total score from baseline (pre-treatment) to the average in the six months post-treatment (measured at immediate post-treatment, 3 and 6 months follow-up visits). We chose to use the average in the six months post-treatment in the definition of primary outcome (versus using a single post-treatment timepoint) because we anticipate that improvement established during the course of treatment will be sustained in the 6 months after treatment for both PE and CPT. Possible range for CAPS-5 total score 0-80. Higher score indicates more severe PTSD.
Time Frame	immediate post-treatment, 3 and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Behavioral: Prolonged Exposure (PE)	Behavioral: Cognitive Processing Therapy (CPT)
Arm/Group Description:	PE is a manualized, 90-minute, 8-15...	CPT consists of cognitive therapy a...
Arm/Group Description:	PE is a manualized, 90-minute, 8-15 week treatment program based on emotional processing theory, which posits that anxiety disorders, including PTSD, reflect pathological fear structures in which emotional and cognitive associations among different elements do not accurately represent reality and renders the individual dysfunctional and distressed. PE is designed to correct erroneous connections in the targeted memory structure. PTSD sufferers typically experience two key pathological emotional response sets and related cognitions: "The world is an utterly dangerous place," and "I am completely incompetent and unable to cope with stress." In this study, the 12-session protocol will be followed, but participants improve more rapidly may finish in 10 sessions and those who improve more slowly may have up to 2 additional sessions to continue working on exposure.	CPT consists of cognitive therapy and a written trauma narrative. Patients are taught to challenge their beliefs through Socratic questioning and the use of daily worksheets. The initial focus is on beliefs such as denial and self-blame, and then shifts to overgeneralized beliefs about self and the world. Patients process their trauma directly by writing a narrative of their traumatic event(s) that they read to themselves and to therapists. The typical protocol consists of 12 1-hr sessions. In this study, the 12-session protocol will be followed, but participants who improve more rapidly may finish in 10 sessions and those who improve more slowly may receive up to 2 additional sessions to continue working on stuck points with challenging beliefs worksheets.
Overall Number of Participants Analyzed	455	461
Mean (95% Confidence Interval) Unit of Measure: score on a scale
Posttreatment	24.3 (22.8 to 25.2)	27.2 (25.5 to 28.9)
3 Months	26.4 (25.1 to 27.8)	28.7 (27.2 to 30.2)
6 Months	24.8 (23.2 to 26.2)	26.9 (25.4 to 28.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Behavioral: Prolonged Exposure (PE), Behavioral: Cognitive Processing Therapy (CPT)
	Comments	Overall Treatment Effect Response Odds Ratio (OR). Response is defined as greater than or equal to 10 point improvement in severity.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.32
	Confidence Interval	(2-Sided) 95% 1.00 to 1.65
	Estimation Comments	Odds ratios were calculated with CPT as the reference group and reflect the overall main effect of treatment across all outcome assessments (post-treatment, 3-months, and 6-months)

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Behavioral: Prolonged Exposure (PE), Behavioral: Cognitive Processing Therapy (CPT)
	Comments	Overall Treatment Effect Loss of Diagnosis Odds Ratio (OR). Loss of Diagnosis is defined as Response, plus no longer meeting DSM-5 symptom criteria and severity less than 25.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.43
	Confidence Interval	(2-Sided) 95% 1.12 to 1.74
	Estimation Comments	Odds ratios were calculated with CPT as the reference group and reflect the overall main effect of treatment across all outcome assessments (post-treatment, 3-months, and 6-months)

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Behavioral: Prolonged Exposure (PE), Behavioral: Cognitive Processing Therapy (CPT)
	Comments	Overall Treatment Effect Remission Odds Ratio (OR). Remission is defined as loss of diagnosis plus severity less than 12.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.62
	Confidence Interval	(2-Sided) 95% 1.24 to 2.00
	Estimation Comments	Odds ratios were calculated with CPT as the reference group and reflect the overall main effect of treatment across all outcome assessments (post-treatment, 3-months, and 6-months)

2.Secondary Outcome


Title	Posttraumatic Diagnostic Scale (PDS-5)
Description	The PDS-5 is a 24-item self-report measure that assesses PTSD symptom ...
Description	The PDS-5 is a 24-item self-report measure that assesses PTSD symptom severity in the last month according to DSM-5 criteria. The outcome is the change of PDS-5 total score from baseline (pre-treatment) to the average in the six months post-treatment (measured at immediate post-treatment, 3 and 6 months follow-up visits). Possible range for PDS-5 score 0-80. Higher PDS-5 Score indicates more severe PTSD Symptoms.
Time Frame	immediate post-treatment, 3 and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Behavioral: Prolonged Exposure (PE)	Behavioral: Cognitive Processing Therapy (CPT)
Arm/Group Description:	PE is a manualized, 90-minute, 8-15...	CPT consists of cognitive therapy a...
Arm/Group Description:	PE is a manualized, 90-minute, 8-15 week treatment program based on emotional processing theory, which posits that anxiety disorders, including PTSD, reflect pathological fear structures in which emotional and cognitive associations among different elements do not accurately represent reality and renders the individual dysfunctional and distressed. PE is designed to correct erroneous connections in the targeted memory structure. PTSD sufferers typically experience two key pathological emotional response sets and related cognitions: "The world is an utterly dangerous place," and "I am completely incompetent and unable to cope with stress." In this study, the 12-session protocol will be followed, but participants improve more rapidly may finish in 10 sessions and those who improve more slowly may have up to 2 additional sessions to continue working on exposure.	CPT consists of cognitive therapy and a written trauma narrative. Patients are taught to challenge their beliefs through Socratic questioning and the use of daily worksheets. The initial focus is on beliefs such as denial and self-blame, and then shifts to overgeneralized beliefs about self and the world. Patients process their trauma directly by writing a narrative of their traumatic event(s) that they read to themselves and to therapists. The typical protocol consists of 12 1-hr sessions. In this study, the 12-session protocol will be followed, but participants who improve more rapidly may finish in 10 sessions and those who improve more slowly may receive up to 2 additional sessions to continue working on stuck points with challenging beliefs worksheets.
Overall Number of Participants Analyzed	455	461
Mean (95% Confidence Interval) Unit of Measure: score on a scale
Posttreatment	33.5 (31.3 to 35.6)	36.7 (34.7 to 38.7)
3 Months	34.5 (32.5 to 36.4)	37.5 (35.6 to 39.4)
6 Months	33.6 (31.6 to 35.5)	36.7 (34.8 to 38.7)

3.Secondary Outcome


Title	Beck Depression Inventory-II (BDI-II)
Description	BDI-II is a brief, self-report inventory designed to measure the sever...
Description	BDI-II is a brief, self-report inventory designed to measure the severity of depression symptomatology. The outcome is the change of BDI-II total score from baseline (pre-treatment) to the average in the six months post-treatment (measured at immediate post-treatment, 3 and 6 months follow-up visits). Possible range for BDI-II 0-63. Higher score indicates more severe depressive symptoms (0-13 minimal, 14-29 mild, 20-28 moderate, 29-63 severe).
Time Frame	immediate post-treatment, 3 and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Behavioral: Prolonged Exposure (PE)	Behavioral: Cognitive Processing Therapy (CPT)
Arm/Group Description:	PE is a manualized, 90-minute, 8-15...	CPT consists of cognitive therapy a...
Arm/Group Description:	PE is a manualized, 90-minute, 8-15 week treatment program based on emotional processing theory, which posits that anxiety disorders, including PTSD, reflect pathological fear structures in which emotional and cognitive associations among different elements do not accurately represent reality and renders the individual dysfunctional and distressed. PE is designed to correct erroneous connections in the targeted memory structure. PTSD sufferers typically experience two key pathological emotional response sets and related cognitions: "The world is an utterly dangerous place," and "I am completely incompetent and unable to cope with stress." In this study, the 12-session protocol will be followed, but participants improve more rapidly may finish in 10 sessions and those who improve more slowly may have up to 2 additional sessions to continue working on exposure.	CPT consists of cognitive therapy and a written trauma narrative. Patients are taught to challenge their beliefs through Socratic questioning and the use of daily worksheets. The initial focus is on beliefs such as denial and self-blame, and then shifts to overgeneralized beliefs about self and the world. Patients process their trauma directly by writing a narrative of their traumatic event(s) that they read to themselves and to therapists. The typical protocol consists of 12 1-hr sessions. In this study, the 12-session protocol will be followed, but participants who improve more rapidly may finish in 10 sessions and those who improve more slowly may receive up to 2 additional sessions to continue working on stuck points with challenging beliefs worksheets.
Overall Number of Participants Analyzed	455	461
Mean (95% Confidence Interval) Unit of Measure: score on a scale
Posttreatment	22.0 (20.5 to 23.5)	22.7 (21.3 to 24.1)
3 Months	22.2 (20.9 to 23.5)	23.6 (22.3 to 24.9)
6 Months	21.9 (20.6 to 23.3)	22.9 (21.5 to 24.2)

4.Secondary Outcome


Title	Spielberger State Anger Inventory (STAXI)
Description	The STAXI is a commonly used measure of trait and state anxiety. The o...
Description	The STAXI is a commonly used measure of trait and state anxiety. The outcome is the change of STAI total score from baseline (pre-treatment) to the average in the six months post-treatment (measured at immediate post-treatment, 3 and 6 months follow-up visits). Possible range for STAXI 44-176. Higher score indicates greater intensity of anger.
Time Frame	immediate post-treatment, 3 and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Behavioral: Prolonged Exposure (PE)	Behavioral: Cognitive Processing Therapy (CPT)
Arm/Group Description:	PE is a manualized, 90-minute, 8-15...	CPT consists of cognitive therapy a...
Arm/Group Description:	PE is a manualized, 90-minute, 8-15 week treatment program based on emotional processing theory, which posits that anxiety disorders, including PTSD, reflect pathological fear structures in which emotional and cognitive associations among different elements do not accurately represent reality and renders the individual dysfunctional and distressed. PE is designed to correct erroneous connections in the targeted memory structure. PTSD sufferers typically experience two key pathological emotional response sets and related cognitions: "The world is an utterly dangerous place," and "I am completely incompetent and unable to cope with stress." In this study, the 12-session protocol will be followed, but participants improve more rapidly may finish in 10 sessions and those who improve more slowly may have up to 2 additional sessions to continue working on exposure.	CPT consists of cognitive therapy and a written trauma narrative. Patients are taught to challenge their beliefs through Socratic questioning and the use of daily worksheets. The initial focus is on beliefs such as denial and self-blame, and then shifts to overgeneralized beliefs about self and the world. Patients process their trauma directly by writing a narrative of their traumatic event(s) that they read to themselves and to therapists. The typical protocol consists of 12 1-hr sessions. In this study, the 12-session protocol will be followed, but participants who improve more rapidly may finish in 10 sessions and those who improve more slowly may receive up to 2 additional sessions to continue working on stuck points with challenging beliefs worksheets.
Overall Number of Participants Analyzed	455	461
Mean (95% Confidence Interval) Unit of Measure: score on a scale
Posttreatment	93.4 (91.4 to 95.4)	94.6 (92.7 to 96.5)
3 Months	93.2 (91.2 to 95.3)	94.7 (92.8 to 96.6)
6 Months	93.2 (91.1 to 95.4)	94.5 (92.6 to 96.4)

5.Secondary Outcome


Title	Short Inventory of Problems - Revised (SIP-R)
Description	The SIP-R assesses alcohol-related consequences. The outcome is the ch...
Description	The SIP-R assesses alcohol-related consequences. The outcome is the change of SIP-R total score from baseline (pre-treatment) to the average in the six months post-treatment (measured at immediate post-treatment, 3 and 6 months follow-up visits). Possible range for SIP-R 0-51. Higher score indicates more severe adverse consequences of substance use.
Time Frame	immediate post-treatment, 3 and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Behavioral: Prolonged Exposure (PE)	Behavioral: Cognitive Processing Therapy (CPT)
Arm/Group Description:	PE is a manualized, 90-minute, 8-15...	CPT consists of cognitive therapy a...
Arm/Group Description:	PE is a manualized, 90-minute, 8-15 week treatment program based on emotional processing theory, which posits that anxiety disorders, including PTSD, reflect pathological fear structures in which emotional and cognitive associations among different elements do not accurately represent reality and renders the individual dysfunctional and distressed. PE is designed to correct erroneous connections in the targeted memory structure. PTSD sufferers typically experience two key pathological emotional response sets and related cognitions: "The world is an utterly dangerous place," and "I am completely incompetent and unable to cope with stress." In this study, the 12-session protocol will be followed, but participants improve more rapidly may finish in 10 sessions and those who improve more slowly may have up to 2 additional sessions to continue working on exposure.	CPT consists of cognitive therapy and a written trauma narrative. Patients are taught to challenge their beliefs through Socratic questioning and the use of daily worksheets. The initial focus is on beliefs such as denial and self-blame, and then shifts to overgeneralized beliefs about self and the world. Patients process their trauma directly by writing a narrative of their traumatic event(s) that they read to themselves and to therapists. The typical protocol consists of 12 1-hr sessions. In this study, the 12-session protocol will be followed, but participants who improve more rapidly may finish in 10 sessions and those who improve more slowly may receive up to 2 additional sessions to continue working on stuck points with challenging beliefs worksheets.
Overall Number of Participants Analyzed	455	461
Mean (95% Confidence Interval) Unit of Measure: score on a scale
Posttreatment	2.61 (1.89 to 3.34)	2.49 (1.76 to 3.23)
3 Months	2.42 (1.58 to 3.25)	2.29 (1.60 to 2.97)
6 Months	3.09 (2.22 to 3.95)	1.72 (0.93 to 2.51)

6.Secondary Outcome


Title	Brief Addiction Monitor (BAM)
Description	The BAM measures an individual's health, alcohol, and drug use. The ou...
Description	The BAM measures an individual's health, alcohol, and drug use. The outcome is the change of BAM total score from baseline (pre-treatment) to the average in the six months post-treatment (measured at immediate post-treatment, 3 and 6 months follow-up visits). Range: 0-4 points. Higher score indicates worse outcome (i.e., more severe addiction).
Time Frame	immediate post-treatment, 3 and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Behavioral: Prolonged Exposure (PE)	Behavioral: Cognitive Processing Therapy (CPT)
Arm/Group Description:	PE is a manualized, 90-minute, 8-15...	CPT consists of cognitive therapy a...
Arm/Group Description:	PE is a manualized, 90-minute, 8-15 week treatment program based on emotional processing theory, which posits that anxiety disorders, including PTSD, reflect pathological fear structures in which emotional and cognitive associations among different elements do not accurately represent reality and renders the individual dysfunctional and distressed. PE is designed to correct erroneous connections in the targeted memory structure. PTSD sufferers typically experience two key pathological emotional response sets and related cognitions: "The world is an utterly dangerous place," and "I am completely incompetent and unable to cope with stress." In this study, the 12-session protocol will be followed, but participants improve more rapidly may finish in 10 sessions and those who improve more slowly may have up to 2 additional sessions to continue working on exposure.	CPT consists of cognitive therapy and a written trauma narrative. Patients are taught to challenge their beliefs through Socratic questioning and the use of daily worksheets. The initial focus is on beliefs such as denial and self-blame, and then shifts to overgeneralized beliefs about self and the world. Patients process their trauma directly by writing a narrative of their traumatic event(s) that they read to themselves and to therapists. The typical protocol consists of 12 1-hr sessions. In this study, the 12-session protocol will be followed, but participants who improve more rapidly may finish in 10 sessions and those who improve more slowly may receive up to 2 additional sessions to continue working on stuck points with challenging beliefs worksheets.
Overall Number of Participants Analyzed	455	461
Mean (95% Confidence Interval) Unit of Measure: score on a scale
Posttreatment	0.88 (0.73 to 1.03)	0.86 (0.69 to 1.02)
3 Months	1.0 (0.84 to 1.16)	0.94 (0.78 to 1.1)
6 Months	0.96 (0.82 to 1.11)	0.80 (0.64 to 0.97)

7.Secondary Outcome


Title	World Health Organization Disability Assessment Schedule (WHO-DAS-II)
Description	The WHO-DAS-II is an assessment instrument for health and disability. ...
Description	The WHO-DAS-II is an assessment instrument for health and disability. The outcome is the change of WHO-DAS-II total score from baseline (pre-treatment) to the average in the six months post-treatment (measured at immediate post-treatment, 3 and 6 months follow-up visits). Possible range for WHODAS-II 12-60. Higher score indicates more difficulty and disability due to health condition.
Time Frame	immediate post-treatment, 3 and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Behavioral: Prolonged Exposure (PE)	Behavioral: Cognitive Processing Therapy (CPT)
Arm/Group Description:	PE is a manualized, 90-minute, 8-15...	CPT consists of cognitive therapy a...
Arm/Group Description:	PE is a manualized, 90-minute, 8-15 week treatment program based on emotional processing theory, which posits that anxiety disorders, including PTSD, reflect pathological fear structures in which emotional and cognitive associations among different elements do not accurately represent reality and renders the individual dysfunctional and distressed. PE is designed to correct erroneous connections in the targeted memory structure. PTSD sufferers typically experience two key pathological emotional response sets and related cognitions: "The world is an utterly dangerous place," and "I am completely incompetent and unable to cope with stress." In this study, the 12-session protocol will be followed, but participants improve more rapidly may finish in 10 sessions and those who improve more slowly may have up to 2 additional sessions to continue working on exposure.	CPT consists of cognitive therapy and a written trauma narrative. Patients are taught to challenge their beliefs through Socratic questioning and the use of daily worksheets. The initial focus is on beliefs such as denial and self-blame, and then shifts to overgeneralized beliefs about self and the world. Patients process their trauma directly by writing a narrative of their traumatic event(s) that they read to themselves and to therapists. The typical protocol consists of 12 1-hr sessions. In this study, the 12-session protocol will be followed, but participants who improve more rapidly may finish in 10 sessions and those who improve more slowly may receive up to 2 additional sessions to continue working on stuck points with challenging beliefs worksheets.
Overall Number of Participants Analyzed	455	461
Mean (95% Confidence Interval) Unit of Measure: score on a scale
Posttreatment	28.6 (27.7 to 29.4)	28.6 (27.8 to 29.4)
3 Months	28.0 (27.1 to 29.0)	28.7 (27.7 to 29.7)
6 Months	28.5 (27.5 to 29.4)	28.5 (27.4 to 29.5)

8.Secondary Outcome


Title	World Health Organization Quality of Life (WHOQoL-BREF)
Description	The WHOQoL-BREF is a quality of life assessment. The outcome is the ch...
Description	The WHOQoL-BREF is a quality of life assessment. The outcome is the change of WHOQoL-BREF assessment sub-category (Physical Health, Psychological, Social Relationships, Environment) scores from baseline (pre-treatment) to the average in the six months post-treatment (measured at immediate post-treatment, 3 and 6 months follow-up visits). Possible range for WHOQOL-BREF 0-100, Physical Health 0-100, Psychological 0-100, Social Relationships 0-100, and Environment 0-100. Higher score indicates better satisfaction with life.
Time Frame	immediate post-treatment, 3 and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Behavioral: Prolonged Exposure (PE)	Behavioral: Cognitive Processing Therapy (CPT)
Arm/Group Description:	PE is a manualized, 90-minute, 8-15...	CPT consists of cognitive therapy a...
Arm/Group Description:	PE is a manualized, 90-minute, 8-15 week treatment program based on emotional processing theory, which posits that anxiety disorders, including PTSD, reflect pathological fear structures in which emotional and cognitive associations among different elements do not accurately represent reality and renders the individual dysfunctional and distressed. PE is designed to correct erroneous connections in the targeted memory structure. PTSD sufferers typically experience two key pathological emotional response sets and related cognitions: "The world is an utterly dangerous place," and "I am completely incompetent and unable to cope with stress." In this study, the 12-session protocol will be followed, but participants improve more rapidly may finish in 10 sessions and those who improve more slowly may have up to 2 additional sessions to continue working on exposure.	CPT consists of cognitive therapy and a written trauma narrative. Patients are taught to challenge their beliefs through Socratic questioning and the use of daily worksheets. The initial focus is on beliefs such as denial and self-blame, and then shifts to overgeneralized beliefs about self and the world. Patients process their trauma directly by writing a narrative of their traumatic event(s) that they read to themselves and to therapists. The typical protocol consists of 12 1-hr sessions. In this study, the 12-session protocol will be followed, but participants who improve more rapidly may finish in 10 sessions and those who improve more slowly may receive up to 2 additional sessions to continue working on stuck points with challenging beliefs worksheets.
Overall Number of Participants Analyzed	455	461
Mean (95% Confidence Interval) Unit of Measure: score on a scale
Physical Health - Posttreatment	47.0 (44.5 to 49.5)	48.6 (46.0 to 51.1)
Physical Health - 3 Months	47.0 (45.7 to 48.2)	47.0 (45.8 to 48.2)
Physical Health - 6 Months	47.1 (45.8 to 48.4)	46.9 (45.6 to 48.2)
Psychological - Posttreatment	49.0 (47.5 to 50.5)	48.9 (47.3 to 50.5)
Psychological - 3 Months	49.1 (47.7 to 50.5)	48.1 (46.7 to 49.4)
Psychological - 6 Months	49.5 (47.9 to 51.1)	49.1 (47.6 to 50.7)
Social Relationship - Posttreatment	45.4 (43.1 to 47.8)	43.9 (41.6 to 46.3)
Social Relationship - 3 Months	46.2 (43.6 to 48.8)	44.1 (41.6 to 46.6)
Social Relationship - 6 Months	46.2 (43.8 to 48.6)	45.5 (42.8 to 48.2)
Environment - Posttreatment	61.1 (59.3 to 62.9)	59.5 (57.6 to 61.3)
Environment - 3 Months	61.5 (59.8 to 63.2)	59.8 (58.2 to 61.4)
Environment - 6 Months	62.3 (60.5 to 64.1)	60.9 (59.2 to 62.6)

Adverse Events

Time Frame	Up to approximately 12 months
Adverse Event Reporting Description	Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.

Arm/Group Title	Behavioral: Prolonged Exposure (PE)		Behavioral: Cognitive Processing Therapy (CPT)
Arm/Group Description	Prolonged Exposure (PE) is a manual...		Cognitive Processing Therapy (CPT) ...
Arm/Group Description	Prolonged Exposure (PE) is a manualized, 90-minute, 8-15 week treatment program based on emotional processing theory, which posits that anxiety disorders, including PTSD, reflect pathological fear structures in which emotional and cognitive associations among different elements do not accurately represent reality and renders the individual dysfunctional and distressed. PE is designed to correct erroneous connections in the targeted memory structure. PTSD sufferers typically experience two key pathological emotional response sets and related cognitions: "The world is an utterly dangerous place," and "I am completely incompetent and unable to cope with stress." In this study, the 12-session protocol will be followed, but participants improve more rapidly may finish in 10 sessions and those who improve more slowly may have up to 2 additional sessions to continue working on exposure.		Cognitive Processing Therapy (CPT) consists of cognitive therapy and a written trauma narrative. Patients are taught to challenge their beliefs through Socratic questioning and the use of daily worksheets. The initial focus is on beliefs such as denial and self-blame, and then shifts to overgeneralized beliefs about self and the world. Patients process their trauma directly by writing a narrative of their traumatic event(s) that they read to themselves and to therapists. The typical protocol consists of 12 1-hr sessions. In this study, the 12-session protocol will be followed, but participants who improve more rapidly may finish in 10 sessions and those who improve more slowly may receive up to 2 additional sessions to continue working on stuck points with challenging beliefs worksheets.
All-Cause Mortality
	Behavioral: Prolonged Exposure (PE)		Behavioral: Cognitive Processing Therapy (CPT)
	Affected / at Risk (%)		Affected / at Risk (%)
Total	1/455 (0.22%)		2/461 (0.43%)
Serious Adverse Events Serious Adverse Events
	Behavioral: Prolonged Exposure (PE)		Behavioral: Cognitive Processing Therapy (CPT)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	55/455 (12.09%)		63/461 (13.67%)
Cardiac disorders
Acute Coronary Syndrome ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Acute myocardial infarction ^† 1	1/455 (0.22%)	1	1/461 (0.22%)	1
Angina Pectoris ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	1
Aortic aneurysm ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	1
Atrial Fibrillation ^† 1	2/455 (0.44%)	3	0/461 (0.00%)	0
Cardiac Arrest ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	1
Cardiomyopathy ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	2
Coronary artery disease ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Heart valve incompetence ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	6
Myocardial infarction ^† 1	0/455 (0.00%)	0	4/461 (0.87%)	6
Palpitations ^† 1	0/455 (0.00%)	0	2/461 (0.43%)	5
Ventricular tachycardia ^† 1	1/455 (0.22%)	9	0/461 (0.00%)	0
Ear and labyrinth disorders
Vertigo ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	1
Vertigo positional ^† 1	0/455 (0.00%)	0	2/461 (0.43%)	2
Endocrine disorders
Hyperparathyroidism ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	5
Gastrointestinal disorders
Abdominal Pain ^† 1	2/455 (0.44%)	2	1/461 (0.22%)	1
Food Poisoning ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	1
Gastrooesophageal reflux disease ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	1
Impaired Gastric Emptying ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	1
Melaena ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Pancreatitis ^† 1	1/455 (0.22%)	2	0/461 (0.00%)	0
Pancreatitis acute ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Small intestinal obstruction ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
General disorders
Adverse Drug Reaction ^† 1	2/455 (0.44%)	2	0/461 (0.00%)	0
Calcinosis ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	2
Chest Pain ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	1
Death ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Drug Interaction ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	1
Hernia ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	4
Ulcer haemorrhage ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	1
Hepatobiliary disorders
Cholelithiasis ^† 1	0/455 (0.00%)	0	2/461 (0.43%)	5
Immune system disorders
Hypersensitivity ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Infections and infestations
Atypical Pneumonia ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	4
Diverticulitis ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Gastroenteritis ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Infected Bite ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	1
Influenza ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	1
Kidney Infection ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Localized Infection ^† 1	1/455 (0.22%)	2	0/461 (0.00%)	0
Lung Infection ^† 1	1/455 (0.22%)	1	1/461 (0.22%)	1
Osteomyelitis ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	1
Pneumonia ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Post Procedural Infection ^† 1	1/455 (0.22%)	4	0/461 (0.00%)	0
Tooth Infection ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	2
Urinary Tract Infection ^† 1	1/455 (0.22%)	2	0/461 (0.00%)	0
Injury, poisoning and procedural complications
Accidental Overdose ^† 1	1/455 (0.22%)	2	2/461 (0.43%)	2
Accidental Poisoning ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	1
Drug Administration Error ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Eye Operation Complication ^† 1	1/455 (0.22%)	2	0/461 (0.00%)	0
Fall ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Incisional hernia ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	1
Intentional Overdose ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	1
Limb Injury ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Overdose ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Post-Procedural Complication ^† 1	1/455 (0.22%)	1	1/461 (0.22%)	1
Post procedural haemorrhage ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	1
Road Traffic Accident ^† 1	2/455 (0.44%)	5	3/461 (0.65%)	3
Snake Bite ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Tendon Injury ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Investigations
Blood Glucose Decreased ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	2
Blood Glucose Increased ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Blood Pressure Increased ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	1
Metabolism and nutrition disorders
Diabetes mellitus inadequate control ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Musculoskeletal and connective tissue disorders
Back Pain ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	2
Intervertebral disc disorder ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Intervertebral disc protrusion ^† 1	1/455 (0.22%)	2	0/461 (0.00%)	0
Lumbar spinal stenosis ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Muscular Weakness ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Osteoarthritis ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of thyroid gland ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Colon Cancer ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	1
Nervous system disorders
Encephalopathy ^† 1	1/455 (0.22%)	2	0/461 (0.00%)	0
Loss of Consciousness ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	3
Presyncope ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	1
Pregnancy, puerperium and perinatal conditions
Delivery ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Psychiatric disorders
Suicide attempt ^† 1	1/455 (0.22%)	2	1/461 (0.22%)	2
Alcohol Abuse ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	2
Alcohol Withdrawal Syndrome ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	2
Anxiety ^† 1	0/455 (0.00%)	0	3/461 (0.65%)	4
Depression ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Depressive Symptom ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	1
Drug Use Disorder ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Homicidal ideation ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	1
Panic Attack ^† 1	1/455 (0.22%)	2	3/461 (0.65%)	3
Panic Disorder ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	2
Post-traumatic stress disorder ^† 1	0/455 (0.00%)	0	2/461 (0.43%)	3
Suicidal ideation ^† 1	6/455 (1.32%)	10	12/461 (2.60%)	18
Violence-related symptom ^† 1	0/455 (0.00%)	0	2/461 (0.43%)	2
Renal and urinary disorders
Nephrolithiasis ^† 1	2/455 (0.44%)	3	0/461 (0.00%)	0
Urinary Retention ^† 1	1/455 (0.22%)	2	0/461 (0.00%)	0
Reproductive system and breast disorders
Breast Enlargement ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	1
Menorrhagia ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	1
Organic erectile dysfunction ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	1
Respiratory, thoracic and mediastinal disorders
Asthma ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Chronic obstructive pulmonary disease ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	1
Pneumothorax ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Pulmonary embolism ^† 1	0/455 (0.00%)	0	2/461 (0.43%)	3
Skin and subcutaneous tissue disorders
Diabetic Foot ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	1
Social circumstances
Physical Assault ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	7
Surgical and medical procedures
Alcohol Detoxification ^† 1	2/455 (0.44%)	5	1/461 (0.22%)	1
Aortic valve replacement ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	1
Cardiac pacemaker insertion ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Drug Detoxification ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	1
Hernia Repair ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Knee arthroplasty ^† 1	1/455 (0.22%)	3	0/461 (0.00%)	0
Knee Operation ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Neck Surgery ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	8
Pharyngeal operation ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Prostatic operation ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Scar excision ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Spinal Fusion Surgery ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	1
Vascular disorders
Hypertension ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Hypertensive Crisis ^† 1	1/455 (0.22%)	2	0/461 (0.00%)	0
1 Term from vocabulary, MedDRA 20.0 † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Behavioral: Prolonged Exposure (PE)		Behavioral: Cognitive Processing Therapy (CPT)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	42/455 (9.23%)		65/461 (14.10%)
Cardiac disorders
Angina Pectoris ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Palpitations ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Eye disorders
Eye Swelling ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	1
Gastrointestinal disorders
Umbilical Hernia ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
General disorders
Adverse Drug Reaction ^† 1	1/455 (0.22%)	1	1/461 (0.22%)	1
Chest Pain ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Crying ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	2
Pain ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Infections and infestations
Lung Infection ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Injury, poisoning and procedural complications
Corneal abrasion ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	1
Drug Administration Error ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Electric Shock ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Limb Injury ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	1
Road Traffic Accident ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	1
Investigations
Drug screen positive ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	1
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	1
Back Pain ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	2
Musculoskeletal pain ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Rotator Cuff Syndrome ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm Malignant ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	1
Nervous system disorders
Disturbance in Attention ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	1
Exaggerated startle response ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	1
Facial Paralysis ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Lumbar radiculopathy ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Paraesthesia ^† 1	1/455 (0.22%)	1	1/461 (0.22%)	1
Seizure ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Psychiatric disorders
Aggression ^† 1	2/455 (0.44%)	2	0/461 (0.00%)	0
Agitation ^† 1	2/455 (0.44%)	3	0/461 (0.00%)	0
Alcohol Abuse ^† 1	1/455 (0.22%)	1	2/461 (0.43%)	3
Alcoholism ^† 1	0/455 (0.00%)	0	2/461 (0.43%)	2
Anxiety ^† 1	0/455 (0.00%)	0	4/461 (0.87%)	4
Attention deficit/hyperactivity disorder ^† 1	1/455 (0.22%)	2	0/461 (0.00%)	0
Depression ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	1
Drug Use Disorder ^† 1	1/455 (0.22%)	2	2/461 (0.43%)	4
Emotional Distress ^† 1	1/455 (0.22%)	1	1/461 (0.22%)	1
Flashback ^† 1	1/455 (0.22%)	2	1/461 (0.22%)	1
Hallucination, Auditory ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Homicidal Ideation ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	1
Hypervigilance ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Intentional Self-Injury ^† 1	0/455 (0.00%)	0	2/461 (0.43%)	2
Intrusive Thoughts ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Irritability ^† 1	2/455 (0.44%)	2	0/461 (0.00%)	0
Nightmare ^† 1	0/455 (0.00%)	0	3/461 (0.65%)	4
Panic Attack ^† 1	1/455 (0.22%)	1	1/461 (0.22%)	1
Post-traumatic Stress Disorder ^† 1	5/455 (1.10%)	8	4/461 (0.87%)	4
Psychiatric decompensation ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Stress ^† 1	0/455 (0.00%)	0	2/461 (0.43%)	3
Suicidal Ideation ^† 1	6/455 (1.32%)	8	12/461 (2.60%)	18
Violence-related symptom ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	1
Respiratory, thoracic and mediastinal disorders
Dyspnoea ^† 1	0/455 (0.00%)	0	2/461 (0.43%)	2
Social circumstances
Burglary Victim ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Death of Companion ^† 1	0/455 (0.00%)	0	2/461 (0.43%)	3
Death of Relative ^† 1	2/455 (0.44%)	4	2/461 (0.43%)	3
Homeless ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	1
Impaired Driving Ability ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	1
Imprisonment ^† 1	2/455 (0.44%)	2	4/461 (0.87%)	5
Legal Problem ^† 1	3/455 (0.66%)	3	2/461 (0.43%)	2
Loss of Employment ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	1
Marital Problem ^† 1	1/455 (0.22%)	2	0/461 (0.00%)	0
Physical Assault ^† 1	2/455 (0.44%)	3	6/461 (1.30%)	9
Shoplifting ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Sick Relative ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Substance Use ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	1
Suicide of Relative ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	1
Surgical and medical procedures
Surgery ^† 1	1/455 (0.22%)	1	0/461 (0.00%)	0
Therapy Cessation ^† 1	0/455 (0.00%)	0	1/461 (0.22%)	1
1 Term from vocabulary, MedDRA 20.0 † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The presentation or publication of any data collected by investigators on participants entered into the VA cooperative study is under the control of the study's Executive Committee. No individual participating investigator is permitted to perform analyses or interpretations or to make public presentations or seek publication of any of the data other than under the auspices and approval of the Executive Committee.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Lisa Zehm
Organization:	Palo Alto CSPCC
Phone:	(650) 493-5000 ext 28805
EMail:	Lisa.Zehm@va.gov

Publications of Results:

Schnurr PP, Chard KM, Ruzek JI, Chow BK, Resick PA, Foa EB, Marx BP, Friedman MJ, Bovin MJ, Caudle KL, Castillo D, Curry KT, Hollifield M, Huang GD, Chee CL, Astin MC, Dickstein B, Renner K, Clancy CP, Collie C, Maieritsch K, Bailey S, Thompson K, Messina M, Franklin L, Lindley S, Kattar K, Luedtke B, Romesser J, McQuaid J, Sylvers P, Varkovitzky R, Davis L, MacVicar D, Shih MC. Comparison of Prolonged Exposure vs Cognitive Processing Therapy for Treatment of Posttraumatic Stress Disorder Among US Veterans: A Randomized Clinical Trial. JAMA Netw Open. 2022 Jan 4;5(1):e2136921. doi: 10.1001/jamanetworkopen.2021.36921.

Other Publications:

Schnurr PP, Chard KM, Ruzek JI, Chow BK, Shih MC, Resick PA, Foa EB, Marx BP, Huang GD, Lu Y. Corrigendum to "Design of VA Cooperative Study #591: CERV-PTSD, Comparative Effectiveness Research in Veterans with PTSD" [Contemp. Clin. Trials 41 (2015) 75-84]. Contemp Clin Trials. 2019 May;80:61. doi: 10.1016/j.cct.2019.04.003. Epub 2019 Apr 5. No abstract available.

Schnurr PP, Chard KM, Ruzek JI, Chow BK, Shih MC, Resick PA, Foa EB, Marx BP, Huang GD, Lu Y. Design of VA Cooperative Study #591: CERV-PTSD, comparative effectiveness research in veterans with PTSD. Contemp Clin Trials. 2015 Mar;41:75-84. doi: 10.1016/j.cct.2014.11.017. Epub 2014 Nov 29. Erratum In: Contemp Clin Trials. 2019 May;80:61.

Layout table for additonal information

Responsible Party:	VA Office of Research and Development
ClinicalTrials.gov Identifier:	NCT01928732
Other Study ID Numbers:	591
First Submitted:	August 16, 2013
First Posted:	August 27, 2013
Results First Submitted:	September 14, 2021
Results First Posted:	January 26, 2022
Last Update Posted:	February 2, 2022

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