TY  - JOUR
PY  - 2024//
TI  - Sequenced treatment effectiveness for posttraumatic stress (STEPS) trial: a protocol for a pragmatic comparative effectiveness trial with baseline results
JO  - Contemporary clinical trials
A1  - Engel, Charles C.
A1  - Kaysen, Debra L.
A1  - Fortney, John C.
A1  - Morland, Leslie A.
A1  - Teo, Alan R.
A1  - Acierno, Ron
A1  - Taylor, Ashley
A1  - Moore, Danna L.
A1  - Bechtel, Jared
A1  - Hauge, Stephanie
A1  - Blanchard, Brittany E.
A1  - Chase, Erin
A1  - Nolan, John P. Jr
A1  - Sripada, Rebecca K.
A1  - Nagel, Nancy
A1  - Cerimele, Joseph M.
A1  - Heagerty, Patrick J.
A1  - Bluett, Ellen
A1  - Debeer, Bryann B.
A1  - Painter, Jacob T.
SP  - ePub
EP  - ePub
VL  - ePub
IS  - ePub
N2  - BACKGROUND: There have only been two efficacy trials reporting a head-to-head comparison of medications and psychotherapy for posttraumatic stress disorder (PTSD), and neither was conducted in primary care. Therefore, in this pragmatic trial we compare outcomes of primary care patients randomized to initially receive a brief trauma-focused psychotherapy or a choice of three antidepressants. In addition, because there are few trials examining the effectiveness of subsequent treatments for patients not responding to the initial treatment, we also compare the outcomes of those switching or augmenting treatments. <br><br>METHOD: Patients screening positive for PTSD (n = 700) were recruited from the primary care clinics of 7 Federally Qualified Health Centers (FQHC) and 8 Department of Veterans Affairs (VA) Medical Centers and randomized in the ratio 1:1:2 to one of three treatment sequences: 1) selective serotonin reuptake inhibitor (SSRI) followed by augmentation with Written Exposure Therapy (WET), 2) SSRI followed by a switch to serotonin-norepinephrine reuptake inhibitor (SNRI), or 3) WET followed by a switch to SSRI. Participants complete surveys at baseline, 6 months, and 12 months. The primary outcome is PTSD symptom severity as measured by the PTSD Checklist (PCL-5). <br><br>RESULTS: The average PCL-5 score was 52.8 (SD = 11.1), indicating considerable severity. The most common bothersome traumatic event for VA enrollees was combat (47.8%), and for FQHC enrollees was other (28.2%), followed by sexual assault (23.4%), and child abuse (19.8%). Only 22.4% were taking an antidepressant at baseline. <br><br>CONCLUSION: Results will help healthcare systems and clinicians make decisions about which treatments to offer to patients. CLINICALTRIALS: govID - NCT04597190.<p />  <p>Language: en</p>
LA  - en
SN  - 1551-7144
UR  - http://dx.doi.org/10.1016/j.cct.2024.107606
ID  - ref1
ER  -