DOI: 10.3886/icpsr39425.v1
title: Comparative Effectiveness PTSD Trial of Sequenced Pharmacotherapy and Psychotherapy in Primary Care, 11 U.S. States, 2021-2024
title: Version 1

description: 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.
description: 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.
description: 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.
description: 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.
description: 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.
description: Presence of Common Scales: 

<strong>Social Support:</strong> ESSI - ENRICHD Social Support Instrument
<strong>Health Literacy:</strong> HLS - Health Literacy Screener
<strong>Beliefs About Mental Health Treatment:</strong> EASI - Endorsed and Anticipated Stigma Inventory
<strong>Perceived Access to PTSD Care:</strong> APAC - Assessment of Perceived Access to Care
<strong>Drug Problems:</strong> DAST-10 - Drug Abuse Screening Test
<strong>PTSD Symptom Severity:</strong> PCL-5 - PTSD Check List
<strong>Mental Health-related Quality of Life:</strong> VR-12 - Veterans RAND 12-item Health Survey
<strong>Recovery, Not Dominated by Symptoms:</strong> RAS - Recovery Assessment Scale
<strong>Depression:</strong> PHQ-9 - Patient Health Questionnaire
<strong>Anxiety:</strong> GAD-7- Generalized Anxiety Disorder
<strong>Alcohol Use:</strong> AUDIT-C -Alcohol Use Disorder Identification Test
<strong>Sleep</strong>: PSQI -Pittsburgh Sleep Quality Index Addendum for PTSD 
<strong>Satisfaction with Mental Health Care:</strong> ECHO - Experience of Care and Health Outcomes
description: For this study, all eligible patients were invited to participate. There were two criteria used for sampling were the inclusion criteria and exclusion criteria. 

<strong>Inclusion Criteria:</strong> 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).



<strong>Exclusion Criteria:</strong> 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).
description: Datasets: 
DS1: Comparative Effectiveness PTSD Trial of Sequenced Pharmacotherapy and Psychotherapy in Primary Care, 11 U.S. States, 2021-2024
description: Patients meeting clinical criteria for PTSD from 7 Community Health Centers (CHCs) and 8 Department of Veterans Affairs (VA) sites.
description: telephone interview; web-based survey