Posttraumatic Stress Disorder
Conditions
Keywords
posttraumatic stress disorder
Brief summary
The proposed project will examine a promising brief therapy for posttraumatic stress Disorder (PTSD) for use in Veterans Health Administration (VHA) Primary Care and its impact on functional outcomes. This intervention will provide an alternative point of access to effective PTSD treatment and improved function that does not require referral to specialty mental health and accomplishes improved function in a short-term, brief protocol. Many Veterans prefer to receive mental health care, including PTSD service in primary care. The current protocol would allow them to access effective therapy options in addition to the medication management that is currently the standard of care for PTSD in primary care. In addition, this brief protocol may reduce the number of specialty mental health referrals as many Veterans may not require additional PTSD specific treatment after completion. Thus, if effective, this protocol will greatly increase Veteran treatment choice and improve functional outcomes and access while also increasing efficiency of allocation of specialty PTSD services.
Detailed description
Posttraumatic stress disorder (PTSD) is a debilitating and costly mental health issue (Greenberg, Sisitsky et al. 1999, Hoge, Terhakopian et al. 2007). PTSD has an estimated two-year cost of $4.0 to $6.2 billion US dollars for mental health issues from the current conflicts in Iraq and Afghanistan and further estimated that providing evidence-based treatments for PTSD and depression could save an estimated $86.2 million (Tanielian, et al. 2008). Even modest reductions in PTSD severity have been related to increased probability of positive function outcomes (Smith, et al. 2005). Prolonged Exposure (PE) therapy (Foa, et al. 2000, Foa, et al. 2005, Schnurr, et al. 2007) is an effective, first-line treatment for PTSD (IOM 2007, VHA/Department of Defense (DOD) 2010). While highly effective, PE is provided in specialty mental health settings typically in 8 to 15, weekly 90 minute individual sessions. Veterans with PTSD are often reluctant to seek care in specialty mental health, and, as a result, many are treated solely in primary care and do not have access to this effective intervention (Possemato, et al. 2011). While the DOD and Veterans Administration (VA) have actively integrated behavioral health providers into their primary care clinics (Maguen, et al. 2010, Seal, et al. 2011), current behavioral interventions for PTSD in primary care are often inconsistent with clinical practice guidelines and/or not effective (Possemato, et al. 2011). Since functional outcomes are critical, the investigators intend to extend beyond assessing the impact of PE-PC on clinical outcomes to function. Thus, there is a clear and urgent need to further develop, validate, and disseminate evidence-based psychotherapeutic treatments for PTSD in integrated VHA Primary Care Mental Health Integration (PC-MHI) with a focus on functional outcomes. To fill this need and gap in care the study investigators developed a Brief Prolonged Exposure for Primary Care (PE-PC) treatment protocol with 4, 30-minute sessions for use in a stepped care model. A pilot study in military treatment facilities found PE-PC resulted in reductions in PTSD that were maintained at 6- and 12-month follow-up (Cigrang, et al, 2015). Preliminary results from a randomized controlled trial (RCT; PI: Cigrang; Co-Investigator: Rauch) of PE-PC compared to minimal attention control (MAC, including continuation of any PC initiated treatment) found a significantly larger reduction in PTSD severity (measured by PCL) in PE-PC than MAC (between group d = .78, p = .01). The strength of these initial findings is limited by lack of functional outcomes and examination of impact in VHA. While Service Members and Veterans have many similarities, potential differences in motivation for treatment and other factors may influence the efficacy of the protocol especially when examining changes in function. The proposed study will randomize 120 Veterans at Ralph H. Johnson Veterans Administration Medical Center (VAMC) presenting in primary care with PTSD who meet minimal inclusion/exclusion criteria to 6 weeks of PE-PC or PC-MHI-treatment as usual (TAU). Recruitment will occur over 36 months. All Veterans will complete a baseline assessment prior to randomization and post-treatment follow-up assessments at Weeks 6, 12, and 24 post-randomization. Primary outcome will be function assessed as self-reported role function in several domains. In addition, the investigators will examine symptoms severity and effectiveness, acceptability, and utilization associated with PE-PC or PCMHI-TAU in the 6 months prior to randomization and 6 months following treatment completion. PE-PC may allow access to effective treatment and efficient allocation of PTSD specialty treatment resources in the VHA. This topic is of key relevance to Veteran mental health care and can provide a new access point for high quality PTSD care to improve function allowing many more Veterans to experience improvement.
Interventions
Brief version of Prolonged Exposure (PE) provided in 30 minute sessions in primary care (PC)
BEHAVIORALTreatment as Usual
Veterans assigned to Primary Care (PC) Mental Health Integration (PCMHI)-Treatment as Usual (TAU) will receive standard PCMHI care for PTSD in PC that does not include any PTSD-specific therapy in PCMHI but may include referral for specialty care (including specialty MH), medication management or general supportive contact while awaiting referral. All PTSD care received during the study will be collected and monitored as TAU.
Sponsors
Ralph H. Johnson VA Medical Center
VA Ann Arbor Healthcare System
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Assessors will not be aware of patient condition and patients will be instructed and reminded not to disclose information that may lead to unblinding
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Any era Veterans seeking care in VA PC for PTSD symptoms \[PTSD Checklist for Diagnostic and Statistical Manual 5 (PCL-5) of at least 28)\] and PTSD confirmed based on Clinician Administered PTSD Scale for Diagnostic and Statistical Manual 5 (CAPS-5) * English speaking * Report significant impairment in function related to PTSD symptoms as noted on intake World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) * Report that they want treatment for PTSD * If individuals are taking psychotropic medication, 2-weeks on stable dose will be required prior to enrollment
Exclusion criteria
* Other primary clinical issue that would interfere with PTSD treatment * Level of suicidal risk as determined by the Columbia Suicide Severity Rating Scale (C-SSRS) that requires: * PTSD + interested and consent to study * Primary Care Provider (PCP) Screen: * Primary Care- Posttraumatic Stress Disorder Screen (PC-PTSD) + Intake * PCMHI Provider: * \[PCL 28\] + brief interview * No PTSD OR * Not interested in treatment OR * Not interested in study * Severe cognitive impairment that, in the judgment of the investigator, makes it unlikely that the patient can adhere to the study regimen * Psychosis or unmanaged bipolar disorder * Moderate to severe substance use disorder in the past 8 weeks * Patients who are currently receiving talk therapy for trauma-related symptoms
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| World Health Organization Disability Assessment Scale 2.0 Change | Week 6 to Week 0 | Change in total score between Week 6 and Week 0 time points can range from 144 (total disability after full function) to 0 (no change) to -144 (total recovery of all function after total disability). Lower change scores reflect more return of function between timepoints. Cut points for this measure have not yet been established. |
| World Health Organization Disability Assessment Scale 2.0 | Week 12 | WHODAS is a 36-item disability interviewer administered assessment covering six domains of function: cognition, mobility, self-care, getting along, life activities, and participation. Each item is scored as none, mild, moderate, severe, or extreme/cannot do. Simple scoring where items are summed across the scale was used. Total scores can range from range from 0 (no disability) to 144 (full disability) with higher scores indicate greater functional impairment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire- 9 (PHQ-9) Change | Week 6 to week 0 | Change scores range between Week 6 and Week 0 time points from 27 (Most severe depression after no depression) to 0 (no change) to -27 (No depression after most severe depression). Lower change score indicates more reduction in depression. Cut points for this change measure have not yet been established. |
| Clinician Administered PTSD Scale for Diagnostic and Statistical Manual 5 (CAPS-5) | Week 12 | CAPS-5 is a 30 -item interviewer administered assessment of PTSD severity over the past month. Each item is scored as absent, mild/subthreshold, moderate/threshold, severe/markedly elevated, or extreme/incapacitating and summed for the total score. The scores ranges from 0 to 80 higher as more severe PTSD. Clinical cut scores for interpretation of this measure have not yet been established. |
| Clinician Administered PTSD Scale for Diagnostic and Statistical Manual 5 (CAPS-5) Change | Week 6 to Week 0 | Change scores range between Week 6 and Week 0 time points from 80 (Most severe PTSD after no PTSD) to 0 (no change) to -80 (No PTSD after most severe PTSD). Lower change score indicates more reduction in PTSD. Cut points for this change measure have not yet been established. |
| Patient Health Questionnaire- 9 (PHQ-9) | Week 12 | PHQ-9 is a 9 item self-report measure of depressive symptoms over the past two weeks. Each item is scored as not at all, several days, more than half days, or nearly every day and summed for the total score. Scores range from 0 (no depression) to 27 (most severe depression). Higher scores would be more severe depression and 10 and higher is considered depressed. Total scores are interpreted as: Minimal 1-4; Mild 5-9; moderate 10-14; Moderately sever 15-19; Severe 20+ |
| PTSD Checklist for Diagnostic and Statistical Manual 5 (PCL-5) | Week 12 | PCL-5 is a 20 item self-report assessment of the PTSD symptoms over the past month. Each item is scored as not at all, a little bit, moderately, quite a bit, or extremely and summed for the total score. The scores ranges from 0 to 80 higher as more severe PTSD. PCL-5 cutoff score between 31-33 is indicative of probable PTSD. |
| PTSD Checklist for Diagnostic and Statistical Manual 5 (PCL-5) Change | Week 6 to Week 0 | Change scores range between Week 6 and Week 0 time points from 80 (Most severe PTSD after no PTSD) to 0 (no change) to -80 (No PTSD after most severe PTSD). Lower change score indicates more reduction in PTSD. Cut points for this change measure have not yet been established. |
Countries
United States
Participant flow
Recruitment details
recruited in VA Primary Care from April 2019 to September 2021
Pre-assignment details
Excluded (n = 129) * Not meeting inclusion criteria or did not consent to study (n = 84) * Declined to participate (n = 45)
Participants by arm
| Arm | Count |
|---|---|
| Prolonged Exposure for Primary Care (PE-PC) Brief version of PE provided in 30 minute sessions in PC
Prolonged Exposure for Primary Care (PE-PC): Brief version of PE provided in 30 minute sessions in PC | 59 |
| Treatment as Usual (TAU) Veterans assigned to PCMHI-TAU will receive standard PCMHI care for PTSD in PC that does not include any PTSD-specific therapy in PCMHI but may include referral for specialty care (including specialty MH), medication management or general supportive contact while awaiting referral. All PTSD care received during the study will be collected and monitored as TAU.
Treatment as Usual: Veterans assigned to PCMHI-TAU will receive standard PCMHI care for PTSD in PC that does not include any PTSD-specific therapy in PCMHI but may include referral for specialty care (including specialty Mental Health (MH)), medication management or general supportive contact while awaiting referral. All PTSD care received during the study will be collected and monitored as TAU. | 61 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 4 |
| Overall Study | Physician Decision | 1 | 2 |
| Overall Study | Withdrawal by Subject | 12 | 13 |
Baseline characteristics
| Characteristic | Prolonged Exposure for Primary Care (PE-PC) | Treatment as Usual (TAU) | Total |
|---|---|---|---|
| Age, Continuous | 44.6 years STANDARD_DEVIATION 11.6 | 42.7 years STANDARD_DEVIATION 14 | 43.6 years STANDARD_DEVIATION 12.8 |
| Clinician Administered PTSD Scale for Diagnostic and Statistical Manual 5 (CAPS-5) | 34.0 units on a scale STANDARD_DEVIATION 8.8 | 34.1 units on a scale STANDARD_DEVIATION 9.3 | 34.0 units on a scale STANDARD_DEVIATION 9 |
| Patient Health Questionnaire 9 (PHQ-9) | 14.1 units on a scale STANDARD_DEVIATION 5.1 | 15.0 units on a scale STANDARD_DEVIATION 5.5 | 14.6 units on a scale STANDARD_DEVIATION 5.3 |
| PTSD Checklist for Diagnostic and Statistical Manual 5(PCL-5) | 49.4 units on a scale STANDARD_DEVIATION 11.6 | 50.9 units on a scale STANDARD_DEVIATION 13 | 50.1 units on a scale STANDARD_DEVIATION 12.3 |
| Race/Ethnicity, Customized Black | 31 Participants | 30 Participants | 61 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 5 Participants | 7 Participants |
| Race/Ethnicity, Customized White | 26 Participants | 26 Participants | 52 Participants |
| Region of Enrollment United States | 59 Participants | 61 Participants | 120 Participants |
| Sex: Female, Male Female | 7 Participants | 15 Participants | 22 Participants |
| Sex: Female, Male Male | 52 Participants | 46 Participants | 98 Participants |
| World Health Organization Disability Assessment Scale 2.0 (WHODAS 2.0) | 48.8 units on a scale STANDARD_DEVIATION 18.1 | 46.7 units on a scale STANDARD_DEVIATION 16.1 | 47.7 units on a scale STANDARD_DEVIATION 17.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 59 | 0 / 61 |
| other Total, other adverse events | 0 / 59 | 0 / 61 |
| serious Total, serious adverse events | 1 / 59 | 0 / 61 |
Outcome results
Primary
World Health Organization Disability Assessment Scale 2.0
WHODAS is a 36-item disability interviewer administered assessment covering six domains of function: cognition, mobility, self-care, getting along, life activities, and participation. Each item is scored as none, mild, moderate, severe, or extreme/cannot do. Simple scoring where items are summed across the scale was used. Total scores can range from range from 0 (no disability) to 144 (full disability) with higher scores indicate greater functional impairment.
Time frame: Week 12
Population: All those with 4 or fewer missing items on the measure are included in the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prolonged Exposure for Primary Care (PE-PC) | World Health Organization Disability Assessment Scale 2.0 | 56.9 units on a scale | Standard Deviation 28.8 |
| Treatment as Usual (TAU) | World Health Organization Disability Assessment Scale 2.0 | 51.5 units on a scale | Standard Deviation 24.1 |
p-value: 0.89Mixed Models Analysis
Primary
World Health Organization Disability Assessment Scale 2.0
WHODAS is a 36-item disability interviewer administered assessment covering six domains of function: cognition, mobility, self-care, getting along, life activities, and participation. Each item is scored as none, mild, moderate, severe, or extreme/cannot do. Simple scoring where items are summed across the scale was used. Total scores can range from range from 0 (no disability) to 144 (full disability) with higher scores indicate greater functional impairment.
Time frame: Week 24
Population: All those with 4 or fewer missing items on the measure are included in the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prolonged Exposure for Primary Care (PE-PC) | World Health Organization Disability Assessment Scale 2.0 | 58.1 units on a scale | Standard Deviation 29.7 |
| Treatment as Usual (TAU) | World Health Organization Disability Assessment Scale 2.0 | 53.9 units on a scale | Standard Deviation 28.3 |
p-value: 0.89Mixed Models Analysis
Primary
World Health Organization Disability Assessment Scale 2.0 Change
Change in total score between Week 6 and Week 0 time points can range from 144 (total disability after full function) to 0 (no change) to -144 (total recovery of all function after total disability). Lower change scores reflect more return of function between timepoints. Cut points for this measure have not yet been established.
Time frame: Week 6 to Week 0
Population: All those with 4 or fewer missing items on the measure are included in the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prolonged Exposure for Primary Care (PE-PC) | World Health Organization Disability Assessment Scale 2.0 Change | -7.5 units on a scale | Standard Deviation 21.3 |
| Treatment as Usual (TAU) | World Health Organization Disability Assessment Scale 2.0 Change | -4.3 units on a scale | Standard Deviation 14.9 |
p-value: 0.3395% CI: [-10.7, 3.6]Mixed Models Analysis
Secondary
Clinician Administered PTSD Scale for Diagnostic and Statistical Manual 5 (CAPS-5)
CAPS-5 is a 30 -item interviewer administered assessment of PTSD severity over the past month. Each item is scored as absent, mild/subthreshold, moderate/threshold, severe/markedly elevated, or extreme/incapacitating and summed for the total score. The scores ranges from 0 to 80 higher as more severe PTSD. Clinical cut scores for interpretation of this measure have not yet been established.
Time frame: Week 12
Population: All those with 4 or fewer missing items on the measure are included in the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prolonged Exposure for Primary Care (PE-PC) | Clinician Administered PTSD Scale for Diagnostic and Statistical Manual 5 (CAPS-5) | 28.8 units on a scale | Standard Deviation 14 |
| Treatment as Usual (TAU) | Clinician Administered PTSD Scale for Diagnostic and Statistical Manual 5 (CAPS-5) | 28.4 units on a scale | Standard Deviation 11.2 |
p-value: 0.99Mixed Models Analysis
Secondary
Clinician Administered PTSD Scale for Diagnostic and Statistical Manual 5 (CAPS-5)
CAPS-5 is a 30 -item interviewer administered assessment of PTSD severity over the past month. Each item is scored as absent, mild/subthreshold, moderate/threshold, severe/markedly elevated, or extreme/incapacitating and summed for the total score. The scores ranges from 0 to 80 higher as more severe PTSD. Clinical cut scores for interpretation of this measure have not yet been established.
Time frame: Week 24
Population: All those with 4 or fewer missing items on the measure are included in the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prolonged Exposure for Primary Care (PE-PC) | Clinician Administered PTSD Scale for Diagnostic and Statistical Manual 5 (CAPS-5) | 28.1 units on a scale | Standard Deviation 12.7 |
| Treatment as Usual (TAU) | Clinician Administered PTSD Scale for Diagnostic and Statistical Manual 5 (CAPS-5) | 28.6 units on a scale | Standard Deviation 11.8 |
p-value: 0.99Mixed Models Analysis
Secondary
Clinician Administered PTSD Scale for Diagnostic and Statistical Manual 5 (CAPS-5) Change
Change scores range between Week 6 and Week 0 time points from 80 (Most severe PTSD after no PTSD) to 0 (no change) to -80 (No PTSD after most severe PTSD). Lower change score indicates more reduction in PTSD. Cut points for this change measure have not yet been established.
Time frame: Week 6 to Week 0
Population: All those with 4 or fewer missing items on the measure are included in the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prolonged Exposure for Primary Care (PE-PC) | Clinician Administered PTSD Scale for Diagnostic and Statistical Manual 5 (CAPS-5) Change | -3.4 units on a scale | Standard Deviation 11.1 |
| Treatment as Usual (TAU) | Clinician Administered PTSD Scale for Diagnostic and Statistical Manual 5 (CAPS-5) Change | -3.1 units on a scale | Standard Deviation 7.4 |
p-value: 0.9995% CI: [-3.6, 3.6]Mixed Models Analysis
Secondary
Patient Health Questionnaire- 9 (PHQ-9)
PHQ-9 is a 9 item self-report measure of depressive symptoms over the past two weeks. Each item is scored as not at all, several days, more than half days, or nearly every day and summed for the total score. Scores range from 0 (no depression) to 27 (most severe depression). Higher scores would be more severe depression and 10 and higher is considered depressed. Total scores are interpreted as: Minimal 1-4; Mild 5-9; moderate 10-14; Moderately sever 15-19; Severe 20+
Time frame: Week 12
Population: All those with 4 or fewer missing items on the measure are included in the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prolonged Exposure for Primary Care (PE-PC) | Patient Health Questionnaire- 9 (PHQ-9) | 12.5 units on a scale | Standard Deviation 6.8 |
| Treatment as Usual (TAU) | Patient Health Questionnaire- 9 (PHQ-9) | 12.8 units on a scale | Standard Deviation 5.9 |
p-value: 0.41Mixed Models Analysis
Secondary
Patient Health Questionnaire- 9 (PHQ-9)
PHQ-9 is a 9 item self-report measure of depressive symptoms over the past two weeks. Each item is scored as not at all, several days, more than half days, or nearly every day and summed for the total score. Scores range from 0 (no depression) to 27 (most severe depression). Higher scores would be more severe depression and 10 and higher is considered depressed. Total scores are interpreted as: Minimal 1-4; Mild 5-9; moderate 10-14; Moderately sever 15-19; Severe 20+
Time frame: Week 24
Population: All those with 4 or fewer missing items on the measure are included in the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prolonged Exposure for Primary Care (PE-PC) | Patient Health Questionnaire- 9 (PHQ-9) | 13.1 units on a scale | Standard Deviation 6.6 |
| Treatment as Usual (TAU) | Patient Health Questionnaire- 9 (PHQ-9) | 12.2 units on a scale | Standard Deviation 5.9 |
p-value: 0.41Mixed Models Analysis
Secondary
Patient Health Questionnaire- 9 (PHQ-9) Change
Change scores range between Week 6 and Week 0 time points from 27 (Most severe depression after no depression) to 0 (no change) to -27 (No depression after most severe depression). Lower change score indicates more reduction in depression. Cut points for this change measure have not yet been established.
Time frame: Week 6 to week 0
Population: All those with 4 or fewer missing items on the measure are included in the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prolonged Exposure for Primary Care (PE-PC) | Patient Health Questionnaire- 9 (PHQ-9) Change | -1.1 units on a scale | Standard Deviation 5.9 |
| Treatment as Usual (TAU) | Patient Health Questionnaire- 9 (PHQ-9) Change | -2.0 units on a scale | Standard Deviation 4.4 |
p-value: 0.595% CI: [-1.4, 2.9]Mixed Models Analysis
Secondary
PTSD Checklist for Diagnostic and Statistical Manual 5 (PCL-5)
PCL-5 is a 20 item self-report assessment of the PTSD symptoms over the past month. Each item is scored as not at all, a little bit, moderately, quite a bit, or extremely and summed for the total score. The scores ranges from 0 to 80 higher as more severe PTSD. PCL-5 cutoff score between 31-33 is indicative of probable PTSD.
Time frame: Week 12
Population: All those with 4 or fewer missing items on the measure are included in the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prolonged Exposure for Primary Care (PE-PC) | PTSD Checklist for Diagnostic and Statistical Manual 5 (PCL-5) | 41.1 units on a scale | Standard Deviation 20.4 |
| Treatment as Usual (TAU) | PTSD Checklist for Diagnostic and Statistical Manual 5 (PCL-5) | 40.2 units on a scale | Standard Deviation 15.6 |
p-value: 0.69Mixed Models Analysis
Secondary
PTSD Checklist for Diagnostic and Statistical Manual 5 (PCL-5)
PCL-5 is a 20 item self-report assessment of the PTSD symptoms over the past month. Each item is scored as not at all, a little bit, moderately, quite a bit, or extremely and summed for the total score. The scores ranges from 0 to 80 higher as more severe PTSD. PCL-5 cutoff score between 31-33 is indicative of probable PTSD.
Time frame: Week 24
Population: All those with 4 or fewer missing items on the measure are included in the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prolonged Exposure for Primary Care (PE-PC) | PTSD Checklist for Diagnostic and Statistical Manual 5 (PCL-5) | 42.1 units on a scale | Standard Deviation 20.5 |
| Treatment as Usual (TAU) | PTSD Checklist for Diagnostic and Statistical Manual 5 (PCL-5) | 40.5 units on a scale | Standard Deviation 16.6 |
p-value: 0.69Mixed Models Analysis
Secondary
PTSD Checklist for Diagnostic and Statistical Manual 5 (PCL-5) Change
Change scores range between Week 6 and Week 0 time points from 80 (Most severe PTSD after no PTSD) to 0 (no change) to -80 (No PTSD after most severe PTSD). Lower change score indicates more reduction in PTSD. Cut points for this change measure have not yet been established.
Time frame: Week 6 to Week 0
Population: All those with 4 or fewer missing items on the measure are included in the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prolonged Exposure for Primary Care (PE-PC) | PTSD Checklist for Diagnostic and Statistical Manual 5 (PCL-5) Change | -6.9 units on a scale | Standard Deviation 18.1 |
| Treatment as Usual (TAU) | PTSD Checklist for Diagnostic and Statistical Manual 5 (PCL-5) Change | -5.7 units on a scale | Standard Deviation 7.7 |
p-value: 0.5295% CI: [-7.3, 3.7]Mixed Models Analysis