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Comparative Effectiveness PTSD Trial of Sequenced Pharmacotherapy and Psychotherapy in Primary Care, 11 U.S. States, 2021-2024 (ICPSR 39425)

Released/updated on: 2025-12-15
Geographic coverage: Oregon, Montana, United States, Texas, Massachusetts, Colorado, Ohio, California, Arkansas, Washington, South Carolina, Michigan
Time period: 2021-04-01--2024-06-30

Based on the state of the scientific evidence, the Sequenced Treatment Effectiveness for Posttraumatic Stress (STEPS) Trial was designed to address three specific aims. The first aim was to quantitatively compare engagement, self-reported PTSD symptom severity (primary outcome), quality of life, and recovery outcomes of primary care patients randomized to initially receive brief psychotherapy (Written Exposure Therapy - WET) or their choice of the three selective serotonin reuptake inhibitors (SSRIs). The second aim was, among patients not responding to initial treatment, to quantitatively compare outcomes of primary care patients randomized to: 1) augment the SSRI with WET, 2) switch from the SSRI to another class of antidepressants (serotonin-norepinephrine reuptake inhibitors - SNRI), or 3) switch from WET to the choice of the three SSRIs. The third specific aim was to quantitatively examine treatment heterogeneity among subgroups of primary care patients receiving pharmacotherapy and psychotherapy, including veterans, women, and those using cannabis.

Curated

Veterans' Pain Care Organizational Improvement Comparative Effectiveness (VOICE) Study, United States, 2017-2022 (ICPSR 38893)

Released/updated on: 2024-12-03
Geographic coverage: United States
Time period: 2017-10-01--2022-04-30

The Veterans' Pain Care Organizational Improvement Comparative Effectiveness (VOICE) Study was a 12-month pragmatic randomized comparative effectiveness trial. The target population was primary care patients (n=820) at ten sites within the United States Department of Veterans Affairs (VA) Health Care System with moderate to severe pain despite treatment with moderate or high-dose long-term opioid treatment (LTOT). The study's primary aim was to compare integrated pain team (IPT) versus pharmacist telecare collaborative management (TCM) for improving pain and reducing opioid use among patients with chronic pain prescribed LTOT. In TCM, a lower-intensity intervention, a clinical pharmacist provides care management, structured symptom monitoring, and pain medication optimization. In IPT, a higher-intensity intervention, an interdisciplinary clinician team delivers care using a multi-modal approach to target biopsychosocial contributors to pain and disability with emphasis on non-drug therapies and behavioral activation sessions.

All participants were randomized to receive either IPT or TCM interventions for 12 months. Common elements of both interventions included individualized pain care and opioid taper recommendations tailored to patient preferences and treatment goals. Outcomes were assessed every three months and the primary time point for comparisons was 12 months. The primary outcome was pain, assessed with the Brief Pain Inventory (BPI) total score, with secondary outcomes as opioid daily dose and quality of life measures.

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