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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MH125857-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This trial is being completed to develop a stepped-care talk therapy model for patients with PTSD. Specifically, this study is testing whether beginning with one type of therapy is better than beginning with another type of therapy, and whether moving to a different therapy after four sessions is more helpful than staying with the same therapy, depending on how well it is working.
The central hypothesis is that beginning with a low- or medium-intensity PTSD intervention and then titrating intensity based on early indications of response will result in clinically significant PTSD symptom reduction with parsimony of resources.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prolonged Exposure for Primary Care (PE-PC) then continue as early responder | Experimental | PE-PC consists of four weekly 30-minute sessions. At the 4th session or 9-week assessment point (whichever comes first), early responders will step down to every-other-week sessions for the duration of the second stage (for 8 weeks). |
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| Clinician Supported (CS) PTSD Coach App then continue as early responder | Experimental | During the first stage of treatment, participants will receive four weekly clinician support sessions or 9 weeks (whichever occurs first). Early responders will be encouraged to continue app use but will discontinue clinician support sessions for the remaining 8 weeks. |
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| Prolonged Exposure for Primary Care (PE-PC) then full PE | Experimental | PE-PC consists of four weekly 30-minute sessions. At the 4th session or 9-week assessment point (whichever comes first), slow responders that are then randomized to full PE and will have sessions once a week for eight weeks. During these 60-minute sessions, participants will practice in vivo and imaginal exposure and continue these exposure exercises every day at home. |
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| Clinician Supported PTSD Coach App then full PE | Experimental | During the first stage of treatment, participants will receive four weekly clinician support sessions or 9 weeks (whichever occurs first), slow responders that are then randomized to full PE will have sessions once a week for eight weeks. During these 60 minute sessions, participants will practice in vivo and imaginal exposure and continue these exposure exercises every day at home. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prolonged Exposure for Primary Care (PE-PC) | Behavioral | Treatment follows the standardized PE-PC manual and workbook.PE-PC consists of four weekly 30-minute sessions. In vivo and imaginal exposure are introduced at the first session and reviewed at Sessions 2-4. To conduct in vivo exposure, participants repeatedly and systematically approach objectively safe people, places, objects, and situations that they avoid because these stimuli remind them of their trauma. At the 4th session or 9-week assessment point (whichever comes first), early responders will step down to every-other-week sessions for the duration of the second stage. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in PTSD symptoms as measured by the Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (CAPS-5) | The CAPS-5 is a clinician-rated PTSD rating scale consisting of 30 items; the total score is calculated as the sum of 20 items assessing the 20 DSM-5 PTSD symptoms. These symptom items are scored on a 5-point scale from 0 (absent) to 4 (extreme/incapacitating). The total score of the 20 items ranges from 0 to 80 with higher scores indicating more severe PTSD symptoms. Therefore, a decrease in the total score indicates symptom improvement. | Baseline, 3-months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in PTSD symptoms by the PTSD Checklist (PCL-5) | The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure that assesses symptoms of PTSD. The PCL-5 has a variety of purposes, including monitoring symptom change during and after treatment. The minimum score is 0, the maximum is 80 (higher scores indicate increased PTSD severity). | Baseline, 3-months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kayla Longuski, MS | Contact | 734-647-6258 | kaylsmit@umich.edu | |
| Heather Walters | Contact | 734-845-3650 | heawalte@umich.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Family Health Care | Terminated | Baldwin | Michigan | 49304 | United States | |
| Grace Health |
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All eligible participants will initially be randomized to one of the two first-stage options, either PE-PC or PTSD coach with clinician support. Participants that have experienced less than a 15-point reduction, have a PCL score of greater than 60 ("very severe"), or cannot be reached for assessment will be classified as slow responders and will be re-randomized to one of two second-stage tactics, either (a) continue in their first-stage treatment strategy, or (b) step up to full PE. Participants who have experienced at least a 15-point symptom reduction or have a PCL score of less than 29 will be classified as early responders and will step down to a lower intensity of their current treatment strategy (i.e., early responders will not be re-randomized).
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The primary outcome, the Clinician-Administered PTSD Scale (CAP-5), will be administered by a blinded study team member.
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| Prolonged Exposure for Primary Care (PE-PC) then continued PE-PC | Experimental | PE-PC consists of four weekly 30-minute sessions. At the 4th session or 9-week assessment point (whichever comes first), slow responders that are then randomized to continue with PE-PC (medium intensity) will continue weekly sessions for 8 weeks. |
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| Clinician Supported PTSD Coach App then continued CS PTSD Coach App | Experimental | During the first stage of treatment, participants will receive four weekly clinician support sessions or 9 weeks (whichever occurs first), slow responders that are then randomized to continue this treatment will have the frequency reduced to twice monthly. |
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| Full Prolonged Exposure | Behavioral | Treatment will follow the standardized PE manual. Participants will have 60 minute sessions once a week for eight weeks During these sessions, participants will practice in vivo, imaginal, and emotional exposure as well as continue these exposure exercises every day at home. |
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| Clinician Supported PTSD Coach App | Behavioral | This is a brief psychotherapy that uses the PTSD Coach mobile app developed by the study team. The PTSD Coach app incorporates evidence-based assessment, psychoeducation, and cognitive behavioral therapy and self-management strategies that are customizable to the user. |
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| Change in depressive symptoms measured by the Patient Health Questionnaire (PHQ-9) | There are 9 questions that reflects the overall functioning and impairment due to the depressive symptoms. Scores ranges from 0 to 27, with a higher score indicating more severe symptoms. | Baseline, 3-months |
| Change in quality of life and functioning measured by the EuroQol-5 Domain (EQ-5D-5L) | The EQ-5D-5L assesses patients' overall quality of life and health. This measure asks questions related to mobility, self-care, activity, pain, and anxiety/depression. Each dimension has five response levels: no problems, slight problems, moderate problems, severe problems, unable to /extreme problems. The participant indicates his/her health state by checking the box next to the most appropriate response level for each of the five dimensions. Higher scores mean better quality of life. Minimum score is 1 and the maximum score is 5 for each dimension. The measure also includes one 0-100 scale assessing how patients perceive their overall health. | Baseline, 3-months |
| Recruiting |
| Battle Creek |
| Michigan |
| 49037 |
| United States |
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| Genesee Community Health Center | Recruiting | Flint | Michigan | 48503 | United States |
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| Hamilton Community Health Network | Recruiting | Flint | Michigan | 48503 | United States |
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| Cherry Health | Recruiting | Grand Rapids | Michigan | 49503 | United States |
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| MidMichigan Community Health Services | Recruiting | Houghton Lake | Michigan | 48629 | United States |
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| Upper Great Lakes Family Health Care Center | Recruiting | Menominee | Michigan | 49858 | United States |
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| Family Medical Center of Michigan | Recruiting | Monroe | Michigan | 48162 | United States |
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| Sterling Area Health Center | Recruiting | Sterling | Michigan | 48659 | United States |
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| Family Care Health Centers | Recruiting | St Louis | Missouri | 63111 | United States |
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| Western North Carolina Community Health Services | Recruiting | Asheville | North Carolina | 28801 | United States |
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| CommUnityCare Health Centers | Recruiting | Austin | Texas | 78702 | United States |
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| Unity Care NW | Recruiting | Bellingham | Washington | 98225 | United States |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D011320 | Primary Health Care |
| ID | Term |
|---|---|
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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