1. Sequenced Treatment Effectiveness for Posttraumatic Stress (STEPS) Trial: A protocol for a pragmatic comparative effectiveness trial with baseline results.
- Author
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Fortney JC, Kaysen DL, Engel CC, Cerimele JM, Nolan JP Jr, Chase E, Blanchard BE, Hauge S, Bechtel J, Moore DL, Taylor A, Acierno R, Nagel N, Sripada RK, Painter JT, DeBeer BB, Bluett E, Teo AR, Morland LA, and Heagerty PJ
- Subjects
- Adult, Female, Humans, Male, Middle Aged, Antidepressive Agents therapeutic use, Antidepressive Agents administration & dosage, Combined Modality Therapy, Comparative Effectiveness Research, Implosive Therapy methods, Primary Health Care, Psychotherapy methods, Serotonin and Noradrenaline Reuptake Inhibitors therapeutic use, Treatment Outcome, Pragmatic Clinical Trials as Topic, Selective Serotonin Reuptake Inhibitors therapeutic use, Selective Serotonin Reuptake Inhibitors administration & dosage, Stress Disorders, Post-Traumatic therapy
- Abstract
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.)
- Published
- 2024
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