Sequenced Treatment Effectiveness for Posttraumatic Stress (STEPS) Trial: A protocol for a pragmatic comparative effectiveness trial with baseline results.

Autor: Fortney JC; Department of Psychiatry and Behavioral Sciences, School of Medicine, University of Washington, Seattle, WA, USA; VA Health Systems Research, Center of Innovation for Veteran-Centered and Value-Driven Care, VA Puget Sound, Seattle, WA, USA. Electronic address: fortneyj@uw.edu., Kaysen DL; Departments of Psychiatry and Behavioral Sciences and Public Mental Health & Population Sciences, School of Medicine, Stanford University, Palo Alto, CA, USA., Engel CC; Department of Psychiatry and Behavioral Sciences, School of Medicine, University of Washington, Seattle, WA, USA; VA Health Systems Research, Center of Innovation for Veteran-Centered and Value-Driven Care, VA Puget Sound, Seattle, WA, USA., Cerimele JM; Department of Psychiatry and Behavioral Sciences, School of Medicine, University of Washington, Seattle, WA, USA; VA Health Systems Research, Center of Innovation for Veteran-Centered and Value-Driven Care, VA Puget Sound, Seattle, WA, USA., Nolan JP Jr; No affiliation., Chase E; Department of Psychiatry and Behavioral Sciences, School of Medicine, University of Washington, Seattle, WA, USA., Blanchard BE; Department of Psychiatry and Behavioral Sciences, School of Medicine, University of Washington, Seattle, WA, USA., Hauge S; Department of Psychiatry and Behavioral Sciences, School of Medicine, University of Washington, Seattle, WA, USA., Bechtel J; Department of Psychiatry and Behavioral Sciences, School of Medicine, University of Washington, Seattle, WA, USA., Moore DL; School of Economic Sciences, Washington State University, Pullman, WA, USA., Taylor A; Primary Care Behavioral Health, VA Bedford Healthcare System, Bedford, MA, USA., Acierno R; Ralph H. Johnson VA Healthcare System, USA; Psychiatry and Behavioral Sciences, McGovern Medical School, University of Texas Health Science Center, Houston, TX, USA., Nagel N; Primary Care Mental Health Integration, Cincinnati VA Medical Center, Cincinnati, OH, USA., Sripada RK; Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA; VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, MI, USA., Painter JT; Health Systems Research Center for Mental Health and Outcomes Research, Central Arkansas Veterans Healthcare System, North Little Rock, AR, USA; College of Pharmacy, University of Arkansas for Medical Sciences, Little Rock, AR, USA., DeBeer BB; Department of Physical Medicine and Rehabilitation, University of Colorado Anschutz Medical Campus, Denver, CO, USA; VA Rocky Mountain Mental Illness, Research, Education, and Clinical Center for Suicide Prevention, Denver, CO, USA., Bluett E; University of Montana, Family Medicine Residency., Teo AR; Department of Psychiatry, Oregon Health & Science University, Portland, OR, USA; Center to Improve Veteran Involvement in Care, Health Systems Research, VA Portland Health Care System, Portland, OR, USA., Morland LA; Department of Psychiatry, Medical University of South Carolina, Charleston, SC, USA; VA San Diego Healthcare System, San Diego, CA, USA., Heagerty PJ; Department of Biostatistics, School of Public Health, University of Washington, Seattle, WA, USA.
Jazyk: angličtina
Zdroj: Contemporary clinical trials [Contemp Clin Trials] 2024 Sep; Vol. 144, pp. 107606. Date of Electronic Publication: 2024 Jun 10.
DOI: 10.1016/j.cct.2024.107606
Abstrakt: Background: There have only been two efficacy trials reporting a head-to-head comparison of medications and psychotherapy for PTSD, and neither was conducted in primary care. Therefore, this protocol paper describes a pragmatic trial that compares 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, this pragmatic trial also compares the outcomes of those switching or augmenting treatments.
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, 4 months, and 8 months. The primary outcome is PTSD symptom severity as measured by the PTSD Checklist (PCL-5).
Results: Average PCL-5 scores (M = 52.8, SD = 11.1) indicated 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.
Conclusion: Results will help healthcare systems and clinicians make decisions about which treatments to offer to patients.
Competing Interests: Declaration of competing interest The authors do not have any personal, professional, or financial conflicts of interest to disclose for this work.
(Published by Elsevier Inc.)
Databáze: MEDLINE
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