Comparative Effectiveness PTSD Trial of Sequenced Pharmacotherapy and Psychotherapy in Primary Care, 11 U.S. States, 2021-2024 (ICPSR 39425)
Version Date: Dec 15, 2025 View help for published
Principal Investigator(s): View help for Principal Investigator(s)
John C. Fortney, University of Washington
https://doi.org/10.3886/ICPSR39425.v1
Version V1
Summary View help for Summary
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:
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.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.
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Restrictions View help for Restrictions
Access to these data is restricted. Users interested in obtaining these data must complete a Restricted Data Use Agreement, specify the reasons for the request, and obtain IRB approval or notice of exemption for their research.
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Study Purpose View help for Study Purpose
This large pragmatic study compared, head-to-head, FDA approved antidepressant medications with a brief trauma-focused psychotherapy that is evidence-based and feasible to deliver in primary care. In addition, despite high treatment non-response rates, very few trials have examined treatment sequencing and none have done so in the primary care setting. For patients not responding to the initial treatment, the proposed research was powered to compare, head-to-head, alternative treatment sequences that were feasible to deliver in primary care. The purposes of the study were to:
1) compare outcomes among patients randomized to initially receive pharmacotherapy or brief psychotherapy,
2) compare outcomes among patients randomized to treatment sequences (i.e., switching and augmenting) for patients not responding to the initial treatment and
3) examine variation in treatment outcomes among different subgroups.
Study Design View help for Study Design
For this study, surveys were administered in English or Spanish via phone or web to patients at baseline (post-randomization, pre-treatment), at 4-month follow-up (post initial treatment) and 8-month follow-up (post sequenced treatment for patients not responding). All telephone surveys were administered by masked interviewers. All baseline surveys were completed within 3 weeks of the randomization date. Follow-up surveys were completed within 3 weeks before/after the target date. Study participants received reminder letters (with $5), emails and texts, and were compensated $50 for completing each of the three surveys. This data collection approach is consistent with Thorpe's recommendations for conducting pragmatic trials because it does not require patients to make frequent clinic visits to complete research assessments, thus minimizing patient burden and attrition bias. In addition, because surveys were completed independently of treatment, outcomes were measured for patients dropping out of treatment.
Additionally, the large pragmatic trial had three arms. Patients were initially randomized to an Serotonin reuptake inhibitor (SSRI) (either sertraline, fluoxetine or paroxetine based on patient preference and treatment history) or Written Exposure Therapy (WET) in a 1:1:2 allocation. The estimated 41 percent of patients that failed to respond to the initial treatment received the second treatment in the sequence. Non-responders randomized to Arm 1 had the SSRI augmented by WET. Non-responders randomized to Arm 2 were switched from the SSRI to venlafaxine. Non-responders in Arm 3 were switched from WET to an SSRI. Treatment would be delivered by primary care and integrated care staff at Community Health Centers (CHCs) and Department of Veterans Affairs (VAs) per recommendation for pragmatic trials [IR-5]. Encounters would be billed for by CHCs and recorded as normal workload by VAs.
Sample View help for Sample
For this study, all eligible patients were invited to participate. There were two criteria used for sampling were the inclusion criteria and exclusion criteria.
Inclusion Criteria: Adult patients screening positive (greater or equal to 3) on the PC-PTSD-5 were assessed for two additional inclusion criteria:
1) exposure to a Criteria A traumatic event according to a short trauma questionnaire and
2) at least moderate PTSD symptom severity (PCL-5 score is greater or equal to 33).
Exclusion Criteria: To ensure patients were appropriate for treatment in primary care exclusion criteria were:
1) recent visit to or future appointment for specialty mental health,
2) diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or dementia,
3) pregnancy,
4) provider believed study participation was not in patient's best interest,
5) recent change in psychotropic medications or currently prescribed venlafaxine,
6) not planning to use clinic or unable to attend appointments, or
7) Unable to speak English or Spanish.
Patients were not excluded if they were on a stable dose of a psychotropic medication(s).
Time Method View help for Time Method
Universe View help for Universe
Patients meeting clinical criteria for PTSD from 7 Community Health Centers (CHCs) and 8 Department of Veterans Affairs (VA) sites.
Unit(s) of Observation View help for Unit(s) of Observation
Data Type(s) View help for Data Type(s)
Mode of Data Collection View help for Mode of Data Collection
Description of Variables View help for Description of Variables
This study contained one dataset (DS1) with 521 variables. The dataset included questions about whether or not the participants were enrolled in the Department of Veterans Affairs, if they served in the US military, experiences with depression, anxiety, alcohol use, substance use and its side effects.
The dataset also included additional demographic variables such as: gender, race, ethnicity, health insurance status, sexual orientation, marital status, employment status, educational status and house hold size of the participants.
Response Rates View help for Response Rates
Of the 1,155 patients meeting all three inclusion criteria, 93.2 percent were assessed for exclusion criteria, and 18.9 percent were excluded. Of those eligible, 81.0 percent consented to participate in the trial, and of those, 87.7 percent (n=614) completed the baseline survey. The 4-month follow-up completion rate was 83.1 percent and the 8-month follow-up completion rate was 80.9 percent.
Presence of Common Scales View help for Presence of Common Scales
Original Release Date View help for Original Release Date
2025-12-15
Version History View help for Version History
2025-12-15 ICPSR data undergo a confidentiality review and are altered when necessary to limit the risk of disclosure. ICPSR also routinely creates ready-to-go data files along with setups in the major statistical software formats as well as standard codebooks to accompany the data. In addition to these procedures, ICPSR performed the following processing steps for this data collection:
- Checked for undocumented or out-of-range codes.
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