Testing adaptive interventions to improve ptsd treatment outcomes in federally qualified health centers

Active Project Grant Awarded Last action

Award ID
R01MH125857
Recipient
Awarding agency
Obligated
$5,979,304

Award facts

Assistance listing
93.242 Mental Health Research Grants
Completion date 86% complete
Originally
Funding
  • $5,171,866.00 Federal
  • $807,438.00 Non-federal
Place of performance
Ann Arbor, MI 48109, USA

Award details come from USAspending.gov.

Description

Abstract
Posttraumatic stress disorder (PTSD) is a debilitating psychiatric disorder that affects 6% of U.S. Adults, yet is left untreated in 70% of affected individuals and up to 85% of low-income individuals. One third of the nation's low-income individuals are treated in federally qualified health centers (FQHCS), which do not have the capacity to provide all their patients with first-line, evidence-based treatments for PTSD such as prolonged exposure (PE). To address this problem, the study team has developed a low-intensity intervention (PTSD coach) and a medium-intensity intervention (PE for primary care: PE-PC) that effectively treat PTSD in low- resource settings. However, some patients will still require high-intensity treatments (e.g., full PE) for sustained clinical benefit. Thus, there is a critical need to develop adaptive, stepped-care models to treat PTSD in FQHCS by combining efficacious treatments, based on response to initial lower-cost strategies. The long- term goal of this line of research is to improve access to efficacious PTSD treatments by implementing empirically-based stepped-care behavioral interventions in low-resource domestic settings. The overall objective in this proposal is to develop a stepped-care intervention for PTSD using a sequential, multiple assignment, randomized trial (SMART). The central hypothesis is that beginning with a low- or medium- intensity PTSD intervention and then titrating intensity based on early indications of response will result in clinically-significant PTSD symptom reduction with parsimony of resources. The rationale is that stepped-care interventions for PTSD are scalable and less costly than static treatments, thereby improving efficiency. To accomplish the objective, this project will employ a SMART design with 430 adults with PTSD in six FQHCS. Participants will be initially randomized to PTSD coach or PE-PC. After four weeks, early responders will step down to lower frequency interaction within their current treatment strategy. Slow responders will be RE- randomized to either continue their current treatment strategy or step up to full PE for eight weeks. The specific aims are to: (1) test the effectiveness of initiating treatment with PE-PC versus PTSD coach in reducing PTSD symptoms at 3 months (ENDPOINT), 6-month follow-up and 9-month follow-up, and (2) test the effectiveness of second-stage tactics (continue or step up to full PE) for slow responders. Exploratory aims are to (a) identify the optimal stepped-care treatment sequence; (B) conduct cost-effectiveness analysis; (C) identify key mediators/moderators of treatment response; and (D) prepare for future implementation through process evaluation. This project will contribute to the field an empirically-based stepped-care intervention for PTSD. This contribution is significant because IT will improve clinical practice for PTSD by establishing an effective treatment sequence that can be delivered in a scalable, sustainable manner. This proposal is innovative because IT will use novel methodologies to help shift the current clinical paradigm of PTSD treatment from fixed, static, and hard-to-access treatment strategies to a dynamic, adaptive, and accessible approach.

Transactions

Action Federal Non-federal Date
Amendment $0 $0
Amendment $723,996 $0
Amendment $730,455 $0
Amendment $669,675 $0
Amendment $716,432 $0
Amendment $716,432 $0
Amendment $807,438 $0
Original award $807,438 $807,438

Subawards

Subrecipient Amount Awarded
Veterans Health Research Institute Of Central New York, Inc. The goal of this subcontract is to allow for Dr. Possemato to train and supervise clinical staff in the Clinician Supported PTSD Coach used in this trial. In… $122,784
Palo Alto Veterans Institute For Research Under this subcontract, Dr. Kuhn will be responsible for coordinating and managing the PTSD Coach app data collection and monitoring, including data storage,… $133,094
Emory University The goal of this subcontract is to allow for Dr. Rauch to lead therapist training in PE and PE-PC that is wholly web-based with webinars and followed by… $112,708
Emory University $323,539

Quick answers

Who received award R01MH125857?

R01MH125857 was awarded to Regents Of The University Of Michigan by National Institute of Mental Health (National Institutes of Health) on September 7, 2021.

How much is award R01MH125857 worth?

$5,979,304 has been obligated on R01MH125857: $5,171,866 in federal funding and $807,438 in non-federal funding.

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