Study protocol for a hybrid 1 effectiveness-implementation trial of Brief Skills Training in Affective and Interpersonal Regulation (Brief STAIR) and web-administered STAIR (webSTAIR) for posttraumatic stress disorder in integrated primary care.

Autor: Godfrey LB; Department of Psychiatry, Boston Medical Center, Boston, MA, USA., Cloitre M; Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA; National Center for PTSD, Dissemination and Training Division at VA Palo Alto Health Care, Palo Alto, CA, USA., Elwy AR; Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, USA; Center for Healthcare Organization and Implementation Research, VA Bedford Healthcare System, Bedford, MA, USA., Fortuna LR; Department of Psychiatry and Behavioral Sciences at University of California, San Francisco, San Francisco, CA, USA., Fuchs C; Department of Psychiatry, Boston Medical Center, Boston, MA, USA; Department of Psychiatry, Boston University Chobanian & Avedisian School of Medicine, Boston, MA, USA., Valentine SE; Department of Psychiatry, Boston Medical Center, Boston, MA, USA; Department of Psychiatry, Boston University Chobanian & Avedisian School of Medicine, Boston, MA, USA. Electronic address: sarah.valentine@bmc.org.
Jazyk: angličtina
Zdroj: Contemporary clinical trials [Contemp Clin Trials] 2023 Aug; Vol. 131, pp. 107241. Date of Electronic Publication: 2023 May 25.
DOI: 10.1016/j.cct.2023.107241
Abstrakt: Background: Posttraumatic stress disorder (PTSD) disproportionally affects low-income, racial and ethnic minoritized communities, where prevalence is high, yet access to evidence-based treatments (EBTs) is low. As such, there is a need to identify effective, feasible, and scalable interventions for PTSD. Stepped care approaches that include brief, low-intensity treatments are one approach to improving access yet have not been developed for adults with PTSD. Our study aims to test the effectiveness of a step one PTSD treatment in primary care while gathering information on implementation to maximize sustainability in the setting.
Methods: This study will be conducted in integrated primary care in the largest safety net hospital in New England using a hybrid type 1 effectiveness-implementation design. Eligible trial participants are adult primary care patients who meet full or subthreshold criteria for PTSD. Interventions include Brief clinician-administered Skills Training in Affective and Interpersonal Regulation (Brief STAIR) versus web-administered STAIR (webSTAIR) during a 15-week active treatment period. Participants complete assessments at baseline (pre-treatment), 15 weeks (post-treatment), and 9 months (follow-up) post-randomization. We will assess feasibility and acceptability post-trial using surveys and interviews with patients, study therapists, and other key informants, and will assess the preliminary effectiveness of interventions in terms of PTSD symptom change and functioning.
Conclusion: This study will provide evidence for the feasibility, acceptability, and preliminary effectiveness of brief, low-intensity interventions in safety net integrated primary care, with the aim of including these interventions in a future stepped care approach to PTSD treatment.
Clinical Trial Number: NCT04937504.
Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2023 Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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