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

Contemp Clin Trials. 2024 Sep:144:107606. doi: 10.1016/j.cct.2024.107606. Epub 2024 Jun 10.

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.

Keywords: Pharmacotherapy; Posttraumatic stress disorder; Primary care; Psychotherapy; Veterans.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Adult
  • Antidepressive Agents / administration & dosage
  • Antidepressive Agents / therapeutic use
  • Combined Modality Therapy
  • Comparative Effectiveness Research
  • Female
  • Humans
  • Implosive Therapy / methods
  • Male
  • Middle Aged
  • Pragmatic Clinical Trials as Topic
  • Primary Health Care
  • Psychotherapy / methods
  • Selective Serotonin Reuptake Inhibitors* / administration & dosage
  • Selective Serotonin Reuptake Inhibitors* / therapeutic use
  • Serotonin and Noradrenaline Reuptake Inhibitors / therapeutic use
  • Stress Disorders, Post-Traumatic* / therapy
  • Treatment Outcome

Substances

  • Antidepressive Agents
  • Selective Serotonin Reuptake Inhibitors
  • Serotonin and Noradrenaline Reuptake Inhibitors