Posttraumatic Stress DisorderPE-PCNCT03581981
Improving Function Through Primary Care Treatment of Posttraumatic Stress Disorder (PTSD)
A study testing Prolonged Exposure for Primary Care (PE-PC) and Treatment as Usual in people with Posttraumatic Stress Disorder, run by VA Office of Research and Development at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Prolonged Exposure for Primary Care (PE-PC) and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2019to 12 Sep 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 14Show fewer
- [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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, 29401-5799
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, 30033-4004
About this study
Official title: Improving Function Through Primary Care Treatment of PTSD
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.
Read the 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.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Prolonged Exposure for Primary Care (PE-PC), Treatment as Usual
- Keywords
- posttraumatic stress disorder
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged Exposure for Primary Care (PE-PC)Behavioural
Also called PE-PC
Brief version of Prolonged Exposure (PE) provided in 30 minute sessions in primary care (PC)
Treatment as UsualBehavioural
Also called TAU
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.
| Study group | Role | What they receive |
|---|---|---|
| Prolonged Exposure for Primary Care (PE-PC) | Experimental | Brief version of PE provided in 30 minute sessions in PC Receives: Behavioral: Prolonged Exposure for Primary Care (PE-PC) |
| Treatment as Usual (TAU) | Active comparator | 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 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. Receives: Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 6 to Week 0
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.
Measured: Week 12
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.
Measured: Week 24
Secondary outcomes (9)
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.
Measured: Week 6 to Week 0
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.
Measured: Week 6 to Week 0
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.
Measured: Week 6 to week 0
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.
Measured: Week 12
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.
Measured: Week 24
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.
Measured: Week 12
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.
Measured: Week 24
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+
Measured: Week 12
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+
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start1 Apr 2019
- Primary completion12 Sep 2022
- Study completion12 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Ralph H. Johnson VA Medical Center, VA Ann Arbor Healthcare System
- Responsible party
- Sponsor
- Investigators
- Sheila A Rauch, PhD, Principal investigator, Atlanta VA Medical and Rehab Center, Decatur, GA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03581981
- Sponsor's protocol ID
- D2625-R
- Acronym
- PE-PC
- Status last verified
- Mar 2024
- First submitted
- 27 Jun 2018
- Last updated
- 15 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rauch SAM, Kim HM, Acierno R, Ragin C, Wangelin B, Blitch K, Muzzy W, Hart S, Zivin K, Cigrang J. Improving function through primary care treatment of PTSD: The IMPACT study protocol. Contemp Clin Trials. 2022 Sep;120:106881. doi: 10.1016/j.cct.2022.106881. Epub 2022 Aug 12.
PubMed 35964868McLean CP, Back SE, Capone C, Morland L, Norman SB, Rauch SAM, Schnurr PP, Teng E, Acierno R. The Impact of COVID-19 on Psychotherapy Participation Among Individuals With Posttraumatic Stress Disorder Enrolled in Treatment Research. J Trauma Stress. 2022 Feb;35(1):308-313. doi: 10.1002/jts.22718. Epub 2021 Jul 22.
PubMed 34291832Rauch SAM, Kim HM, Acierno R, Ragin C, Wangelin B, Blitch K, Muzzy W, Hart S, Zivin K. Improving function through primary care treatment of posttraumatic stress disorder study outcomes: A randomized controlled trial of prolonged exposure for primary care in veterans. Fam Syst Health. 2023 Dec;41(4):502-513. doi: 10.1037/fsh0000823. Epub 2023 Aug 31.
PubMed 37650808
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Function Through Primary Care Treatment of PTSD
- ClinicalTrials.gov ID
- NCT03581981
- Acronym / sponsor ID
- PE-PC / D2625-R
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- posttraumatic stress disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Ralph H. Johnson VA Medical Center, VA Ann Arbor Healthcare System
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 12 Sep 2022 (actual)
- Study completion
- 12 Sep 2022 (actual)
- First posted
- 10 Jul 2018 (actual)
- Results
- Posted 15 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prolonged Exposure for Primary Care (PE-PC) | Experimental | Behavioral: Prolonged Exposure for Primary Care (PE-PC)Brief version of PE provided in 30 minute sessions in PC |
| Treatment as Usual (TAU) | Active comparator | Behavioral: Treatment as UsualVeterans 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 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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:
- Primary Care Provider (PCP) Screen:
- PCMHI Provider:
- Severe cognitive impairment that, in the judgment of the investigator, makes it unlikely that the patient can adhere to the study regimen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prolonged Exposure for Primary Care (PE-PC)Also: PE-PCBrief version of Prolonged Exposure (PE) provided in 30 minute sessions in primary care (PC) | Behavioural | Prolonged Exposure for Primary Care (PE-PC) |
| Treatment as UsualAlso: TAUVeterans 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. | Behavioural | Treatment as Usual (TAU) |
Primary outcome
World Health Organization Disability Assessment Scale 2.0 Change
Time frame: 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
Time frame: 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.
World Health Organization Disability Assessment Scale 2.0
Time frame: Week 24
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.
9 secondary outcomes
Clinician Administered PTSD Scale for Diagnostic and Statistical Manual 5 (CAPS-5) Change
Time frame: Week 6 to Week 0
PTSD Checklist for Diagnostic and Statistical Manual 5 (PCL-5) Change
Time frame: Week 6 to Week 0
Patient Health Questionnaire- 9 (PHQ-9) Change
Time frame: Week 6 to week 0
Clinician Administered PTSD Scale for Diagnostic and Statistical Manual 5 (CAPS-5)
Time frame: Week 12
Clinician Administered PTSD Scale for Diagnostic and Statistical Manual 5 (CAPS-5)
Time frame: Week 24
PTSD Checklist for Diagnostic and Statistical Manual 5 (PCL-5)
Time frame: Week 12
PTSD Checklist for Diagnostic and Statistical Manual 5 (PCL-5)
Time frame: Week 24
Patient Health Questionnaire- 9 (PHQ-9)
Time frame: Week 12
Patient Health Questionnaire- 9 (PHQ-9)
Time frame: Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 35964868Rauch SAM, Kim HM, Acierno R, Ragin C, Wangelin B, Blitch K, Muzzy W, Hart S, Zivin K, Cigrang J. Improving function through primary care treatment of PTSD: The IMPACT study protocol. Contemp Clin Trials. 2022 Sep;120:106881. doi: 10.1016/j.cct.2022.106881. Epub 2022 Aug 12.
- Background: PubMed 34291832McLean CP, Back SE, Capone C, Morland L, Norman SB, Rauch SAM, Schnurr PP, Teng E, Acierno R. The Impact of COVID-19 on Psychotherapy Participation Among Individuals With Posttraumatic Stress Disorder Enrolled in Treatment Research. J Trauma Stress. 2022 Feb;35(1):308-313. doi: 10.1002/jts.22718. Epub 2021 Jul 22.
- Derived from this study: PubMed 37650808Rauch SAM, Kim HM, Acierno R, Ragin C, Wangelin B, Blitch K, Muzzy W, Hart S, Zivin K. Improving function through primary care treatment of posttraumatic stress disorder study outcomes: A randomized controlled trial of prolonged exposure for primary care in veterans. Fam Syst Health. 2023 Dec;41(4):502-513. doi: 10.1037/fsh0000823. Epub 2023 Aug 31.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheila A Rauch, PhD principal investigator
Atlanta VA Medical and Rehab Center, Decatur, GA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged Exposure for Primary Care (PE-PC) and Treatment as Usual in people with Posttraumatic Stress Disorder, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
World Health Organization Disability Assessment Scale 2.0 Change (time frame: Week 6 to Week 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03581981, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2024.