Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Change from Baseline on the Clinician-Administered PTSD Scale for DSM-5 |
PTSD symptoms rating scale (severity and frequency) administered by blinded clinician |
1 week posttreatment |
|
| Primary |
Change from Baseline on the Clinician-Administered PTSD Scale for DSM-5 |
PTSD symptoms rating scale (severity and frequency) administered by blinded clinician |
3 months posttreatment |
|
| Primary |
Change from Baseline on the Clinician-Administered PTSD Scale for DSM-5 |
PTSD symptoms rating scale (severity and frequency) administered by blinded clinician |
6 months posttreatment |
|
| Secondary |
Change from Baseline on the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) |
Patient Self Report of PTSD symptoms |
1 week posttreatment |
|
| Secondary |
Change from Baseline on the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) |
Patient Self Report of PTSD symptoms |
3 months posttreatment |
|
| Secondary |
Change from Baseline on the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) |
Patient Self Report of PTSD symptoms |
6 months posttreatment |
|
| Secondary |
Change from Baseline on the Traumatic Life Events Questionnaire (TLEQ) |
self-report measure assessing lifetime history of 22 traumatic events |
1 week posttreatment |
|
| Secondary |
Change from Baseline on the Traumatic Life Events Questionnaire (TLEQ) |
self-report measure assessing lifetime history of 22 traumatic events |
3 months posttreatment |
|
| Secondary |
Change from Baseline on the Traumatic Life Events Questionnaire (TLEQ) |
self-report measure assessing lifetime history of 22 traumatic events |
6 months posttreatment |
|
| Secondary |
Change from Baseline on the Trauma-Related Guilt Inventory (TRGI) |
32-item measure rating 3 domains of trauma-related guilt cognitions (Global Guilt, Distress, and Guilt Cognitions) |
1 week posttreatment |
|
| Secondary |
Change from Baseline on the Trauma-Related Guilt Inventory (TRGI) |
32-item measure rating 3 domains of trauma-related guilt cognitions (Global Guilt, Distress, and Guilt Cognitions) |
3 months posttreatment |
|
| Secondary |
Change from Baseline on the Trauma-Related Guilt Inventory (TRGI) |
32-item measure rating 3 domains of trauma-related guilt cognitions (Global Guilt, Distress, and Guilt Cognitions) |
6 months posttreatment |
|
| Secondary |
Change from Baseline on the Posttraumatic Cognitions Inventory (PTCI) |
36-item measure assessing 3 domains of trauma-related cognitions (Negative Cognitions about Self, Negative Cognitions about the World, and Self-Blame) |
1 week posttreatment |
|
| Secondary |
Change from Baseline on the Posttraumatic Cognitions Inventory (PTCI) |
36-item measure assessing 3 domains of trauma-related cognitions (Negative Cognitions about Self, Negative Cognitions about the World, and Self-Blame) |
3 months posttreatment |
|
| Secondary |
Change from Baseline on the Posttraumatic Cognitions Inventory (PTCI) |
36-item measure assessing 3 domains of trauma-related cognitions (Negative Cognitions about Self, Negative Cognitions about the World, and Self-Blame) |
6 months posttreatment |
|
| Secondary |
Change from Baseline on the Moral Injury Event Scale (MIES) |
patient-report measure assessing psychological distress associated with violations of moral standards. |
1 week posttreatment |
|
| Secondary |
Change from Baseline on the Moral Injury Event Scale (MIES) |
patient-report measure assessing psychological distress associated with violations of moral standards. |
3 months posttreatment |
|
| Secondary |
Change from Baseline on the Moral Injury Event Scale (MIES) |
patient-report measure assessing psychological distress associated with violations of moral standards. |
6 months posttreatment |
|
| Secondary |
Change from baseline on the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) |
patient report of impairment in six domains: cognition, mobility, self-care, getting along with people, life activities (at home and work), and participation in society |
1 week posttreatment |
|
| Secondary |
Change from baseline on the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) |
patient report of impairment in six domains: cognition, mobility, self-care, getting along with people, life activities (at home and work), and participation in society |
3 months posttreatment |
|
| Secondary |
Change from baseline on the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) |
patient report of impairment in six domains: cognition, mobility, self-care, getting along with people, life activities (at home and work), and participation in society |
6 months posttreatment |
|
| Secondary |
Change from baseline on the Quality of Life Scale (QOLS) |
Patient report of 6 domains of life: independence, recreation, personal development and fulfillment, material and physical well-being, relationships with others, and community and civic involvement |
1 week posttreatment |
|
| Secondary |
Change from baseline on the Quality of Life Scale (QOLS) |
Patient report of 6 domains of life: independence, recreation, personal development and fulfillment, material and physical well-being, relationships with others, and community and civic involvement |
3 months posttreatment |
|
| Secondary |
Change from baseline on the Quality of Life Scale (QOLS) |
Patient report of 6 domains of life: independence, recreation, personal development and fulfillment, material and physical well-being, relationships with others, and community and civic involvement |
6 months posttreatment |
|
| Secondary |
Change from baseline on the Connor-Davidson Resilience Scale (CD-RISC) |
Patient report of coping ability |
1 week posttreatment |
|
| Secondary |
Change from baseline on the Connor-Davidson Resilience Scale (CD-RISC) |
Patient report of coping ability |
3 months posttreatment |
|
| Secondary |
Change from baseline on the Connor-Davidson Resilience Scale (CD-RISC) |
Patient report of coping ability |
6 months posttreatment |
|
| Secondary |
Change from baseline on the Patient Health Questionnaire-9 (PHQ-9) |
Patient report measure of depression symptoms |
1 week posttreatment |
|
| Secondary |
Change from baseline on the Patient Health Questionnaire-9 (PHQ-9) |
Patient report measure of depression symptoms |
3 months posttreatment |
|
| Secondary |
Change from baseline on the Patient Health Questionnaire-9 (PHQ-9) |
Patient report measure of depression symptoms |
6 months posttreatment |
|
| Secondary |
Change from baseline on the Generalized Anxiety Disorder-7 (GAD-7) |
Patient report measure of general anxiety symptoms |
1 week posttreatment |
|
| Secondary |
Change from baseline on the Generalized Anxiety Disorder-7 (GAD-7) |
Patient report measure of general anxiety symptoms |
3 months posttreatment |
|
| Secondary |
Change from baseline on the Generalized Anxiety Disorder-7 (GAD-7) |
Patient report measure of general anxiety symptoms |
6 months posttreatment |
|
| Secondary |
Change from baseline on the Dimensions of Anger Reactions-5 (DAR-5) |
Patient report measure of anger |
1 week posttreatment |
|
| Secondary |
Change from baseline on the Dimensions of Anger Reactions-5 (DAR-5) |
Patient report measure of anger |
3 months posttreatment |
|
| Secondary |
Change from baseline on the Dimensions of Anger Reactions-5 (DAR-5) |
Patient report measure of anger |
6 months posttreatment |
|
| Secondary |
Change from baseline on the Clinical Global Impressions Scales (CGI) |
Clinician rated scales to evaluate the severity of pretreatment psychopathology and treatment change |
1 week posttreatment |
|
| Secondary |
Change from baseline on the Clinical Global Impressions Scales (CGI) |
Clinician rated scales to evaluate the severity of pretreatment psychopathology and treatment change |
3 months posttreatment |
|
| Secondary |
Change from baseline on the Clinical Global Impressions Scales (CGI) |
Clinician rated scales to evaluate the severity of pretreatment psychopathology and treatment change |
6 months posttreatment |
|
| Secondary |
Sleep actigraphy - change from baseline in total sleep time |
Objective assessment of sleep |
1 week posttreatment |
|
| Secondary |
Sleep actigraphy - change from baseline in total sleep time |
Objective assessment of sleep |
3 months posttreatment |
|
| Secondary |
Sleep actigraphy - change from baseline in total sleep time |
Objective assessment of sleep |
6 months posttreatment |
|
| Secondary |
Sleep actigraphy - change from baseline in sleep onset latency |
Objective assessment of sleep (# of minutes to sleep onset after getting into bed) |
1 week posttreatment |
|
| Secondary |
Sleep actigraphy - change from baseline in sleep onset latency |
Objective assessment of sleep (# of minutes to sleep onset after getting into bed) |
3 months posttreatment |
|
| Secondary |
Sleep actigraphy - change from baseline in sleep onset latency |
Objective assessment of sleep (# of minutes to sleep onset after getting into bed) |
6 months posttreatment |
|
| Secondary |
Sleep actigraphy - change from baseline in sleep efficiency |
Objective assessment of sleep (% of time in bed spent sleeping) |
1 week posttreatment |
|
| Secondary |
Sleep actigraphy - change from baseline in sleep efficiency |
Objective assessment of sleep (% of time in bed spent sleeping) |
3 months posttreatment |
|
| Secondary |
Sleep actigraphy - change from baseline in sleep efficiency |
Objective assessment of sleep (% of time in bed spent sleeping) |
6 months posttreatment |
|
| Secondary |
Sleep actigraphy - change from baseline in wake minutes after sleep onset |
Objective assessment of sleep (# of minutes awake after falling asleep) |
1 week posttreatment |
|
| Secondary |
Sleep actigraphy - change from baseline in wake minutes after sleep onset |
Objective assessment of sleep (# of minutes awake after falling asleep) |
3 months posttreatment |
|
| Secondary |
Sleep actigraphy - change from baseline in wake minutes after sleep onset |
Objective assessment of sleep (# of minutes awake after falling asleep) |
6 months posttreatment |
|
