Viewing Study NCT04597190



Ignite Creation Date: 2024-05-06 @ 3:19 PM
Last Modification Date: 2024-10-26 @ 1:47 PM
Study NCT ID: NCT04597190
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2024-06-28
First Post: 2020-10-01

Brief Title: Sequenced Treatment Effectiveness for Posttraumatic Stress
Sponsor: University of Washington
Organization: University of Washington

Study Overview

Official Title: Comparative Effectiveness PTSD Trial of Sequenced Pharmacotherapy and Psychotherapy in Primary Care
Status: ACTIVE_NOT_RECRUITING
Status Verified Date: 2024-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: STEPS
Brief Summary: Individuals with PTSD are more likely to engage in unhealthy behaviors such as tobacco use drug use alcohol misuse and have high rates of morbiditymortality PTSD negatively impacts marriages educational attainment and occupational functioning Some patients with PTSD can be successfully referred to specialty mental health clinics but most patients with PTSD cannot engage in specialty care because of geographical financial and cultural barriers and must be treated in primary care However policy makers do not know the best way to treat PTSD in primary care clinics especially for patients who do not respond to the initial treatment choice There are effective treatments for PTSD that are feasible to deliver in primary care These treatments include commonly prescribed antidepressants and brief exposure-based therapies However because there are no head-to-head comparisons between pharmacotherapy and psychotherapy in primary care settings primary care providers do not know which treatments to recommend to their patients In addition despite high treatment non-response rates very few studies have examined which treatment should be recommend next when patients do not respond well to the first and no such studies have been conducted in primary care settings

This trial will be conducted in Federally Qualified Health Centers and VA Medical Centers where the prevalence of both past trauma exposure and PTSD are particularly high The investigators will enroll 700 primary care patients The investigators propose to 1 compare outcomes among patients randomized to initially receive pharmacotherapy or brief psychotherapy 2 compare outcomes among patients randomized to treatment sequences ie switching and augmenting for patients not responding to the initial treatment and 3 examine variation in treatment outcomes among different subgroups of patients Telephone and web surveys will be used to assessed outcomes important to patients like self-reported symptom burden side-effects health related quality of life and recovery outcomes at baseline 4 and 8 months Results will help patients and primary care providers choose which treatment to try first and which treatment to try second if the first is not effective
Detailed Description: Background In primary care settings PTSD frequently goes undetected and untreated When PTSD is diagnosed in primary care treatment is usually inadequate and outcomes are poor This is highly problematic because many patients with PTSD prefer receiving care in primary care settings and less than half are successfully referred to the specialty mental health setting This is especially a concern for safety net primary settings such as Federally Qualified Health Centers and VA Medical Centers where the prevalence of both past trauma exposure and PTSD are particularly high However there are effective pharmacotherapy and psychotherapy treatments for PTSD that are feasible to deliver in primary care

Objective Because there are no head-to-head comparisons of pharmacotherapy and psychotherapy for PTSD among primary care patients the investigators propose to 1 compare outcomes among patients randomized to initially receive pharmacotherapy or brief psychotherapy 2 compare outcomes among patients randomized to treatment sequences ie switching and augmenting for patients not responding to the initial treatment and 3 examine variation in treatment outcomes among different subgroups of patients

Methods This multi-site trial will enroll 700 patients meeting clinical criteria for PTSD from 7 Federally Qualified Health Centers and 8 VA Medical Centers The pharmacotherapy treatments are sertraline fluoxetine paroxetine and venlafaxine The psychotherapy treatment is Written Exposure Therapy Telephone and web surveys will be used to assessed outcomes patient treatment engagement self-reported symptom burden health related quality of life and recovery outcomes at baseline 4 and 8 months Patients will be the unit of the intent-to-treat analysis Multiple imputation will be used for missing data Mixed-models will be used to test hypotheses

Significance Due to a lack of head-to-head comparisons between pharmacotherapy and psychotherapy protocols clinical practice guidelines for PTSD provide contradictory recommendations about pharmacotherapy and psychotherapy In particular PTSD clinical practice guidelines have little to offer primary care providers because so few trials have been conducted in this setting The proposed large pragmatic trial will compare head-to-head FDA approved PTSD 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 is powered to compare head-to-head alternative treatment sequences that are feasible to deliver in primary care

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None