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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

Study to Promote Innovation in Rural Integrated Telepsychiatry (SPIRIT), Arkansas, Michigan, and Washington, 2016-2020 (ICPSR 38542)

Released/updated on: 2022-12-14
Geographic coverage: United States, Arkansas, Washington, Michigan
Time period: 2016-01-01--2020-01-01

This study addressed whether it is better to expand the scope of collaborative care programs to treat patients with more complex psychiatric disorders or to facilitate successful referrals to specialty mental health care. The primary objective of this study is to compare Telepsychiatry Collaborative Care (TCC) and Telepsychiatry Enhanced Referral (TER) from the patient and provider perspective. The secondary objective is to determine whether patients not engaging and responding to TER, improve with Phone-Psychiatry Enhanced Referral (PER). There are four specific aims.

Aim #1: To quantitatively compare the treatment experience, engagement, self-reported clinical outcomes, and recovery-oriented outcomes of patients initially randomized to TCC and TER.

Aim #2: For the subset of patients randomized to TER who do not engage in treatment and are still symptomatic at 6 months, quantitatively compare treatment experience, treatment engagement, self-reported clinical outcomes and recovery-oriented outcomes of patients randomized to continued-TER or PER.

Aim #3: To gain an in-depth understanding of patients' and providers' treatment experience, qualitatively compare those randomized to TCC, TER and PER.

Aim #4: To examine treatment heterogeneity among subgroups of patients randomized to TCC and TER based on race/ethnicity, age and clinical severity.

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