Improving Function Through Primary Care Treatment of Posttraumatic Stress Disorder (PTSD) (PE-PC)
Improving Function Through Primary Care Treatment of PTSD
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Georgia
-
Decatur, Georgia, United States, 30033-4004
- Atlanta VA Medical and Rehab Center, Decatur, GA
-
-
South Carolina
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Charleston, South Carolina, United States, 29401-5799
- Ralph H. Johnson VA Medical Center, Charleston, SC
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Prolonged Exposure for Primary Care (PE-PC)
Brief version of PE provided in 30 minute sessions in PC
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Brief version of Prolonged Exposure (PE) provided in 30 minute sessions in primary care (PC)
Other Names:
|
|
Active Comparator: Treatment as Usual (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 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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Week 6 to Week 0
|
|
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.
|
Week 12
|
|
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.
|
Week 24
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinician Administered PTSD Scale for Diagnostic and Statistical Manual 5 (CAPS-5) Change
Time Frame: 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.
|
Week 6 to Week 0
|
|
PTSD Checklist for Diagnostic and Statistical Manual 5 (PCL-5) Change
Time Frame: 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.
|
Week 6 to Week 0
|
|
Patient Health Questionnaire- 9 (PHQ-9) Change
Time Frame: 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.
|
Week 6 to week 0
|
|
Clinician Administered PTSD Scale for Diagnostic and Statistical Manual 5 (CAPS-5)
Time Frame: 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.
|
Week 12
|
|
Clinician Administered PTSD Scale for Diagnostic and Statistical Manual 5 (CAPS-5)
Time Frame: Week 24
|
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.
|
Week 24
|
|
PTSD Checklist for Diagnostic and Statistical Manual 5 (PCL-5)
Time Frame: 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.
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Week 12
|
|
PTSD Checklist for Diagnostic and Statistical Manual 5 (PCL-5)
Time Frame: Week 24
|
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.
|
Week 24
|
|
Patient Health Questionnaire- 9 (PHQ-9)
Time Frame: 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+
|
Week 12
|
|
Patient Health Questionnaire- 9 (PHQ-9)
Time Frame: Week 24
|
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+
|
Week 24
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Sheila A Rauch, PhD, Atlanta VA Medical and Rehab Center, Decatur, GA
Publications and helpful links
General 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.
- McLean 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.
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- D2625-R
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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