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. 2023 Aug:131:107241.
doi: 10.1016/j.cct.2023.107241. Epub 2023 May 25.

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

Laura B Godfrey  1 , Marylène Cloitre  2 , A Rani Elwy  3 , Lisa R Fortuna  4 , Cara Fuchs  5 , Sarah E Valentine  6
Affiliations

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

Laura B Godfrey et al. Contemp Clin Trials. 2023 Aug.

Abstract

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.

Keywords: Effectiveness; Hybrid; Implementation; Posttraumatic stress disorder; Stepped care.

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Conflict of interest statement

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.

Figures

Figure 1.
Figure 1.. I-STEP Timeline
Note. Timeline illustrating I-STEP study participation. PCL-5 = PTSD checklist for the DSM-5. RA = research assistant.
See this image and copyright information in PMC

References

    1. Schleimer JP, Buggs SA, McCort CD, et al. Neighborhood Racial and Economic Segregation and Disparities in Violence During the COVID-19 Pandemic. Am J Public Health. 2022;112(1):144–153. doi:10.2105/AJPH.2021.306540 - DOI - PMC - PubMed
    1. Gillespie CF, Bradley B, Mercer K, et al. Trauma Exposure and Stress-Related Disorders in Inner City Primary Care Patients. Gen Hosp Psychiatry. 2009;31(6):505–514. doi:10.1016/j.genhosppsych.2009.05.003 - DOI - PMC - PubMed
    1. Gluck RL, Hartzell GE, Dixon HD, et al. Trauma exposure and stress-related disorders in a large, urban, predominantly African-American, female sample. Arch Womens Ment Health. 2021;24(6):893–901. doi:10.1007/s00737-021-01141-4 - DOI - PMC - PubMed
    1. U.S. Department of Veterans Affairs National Center for PTSD. How Common Is PTSD in Adults? Updated February 3, 2023. Accessed February 15, 2023. https://www.ptsd.va.gov/understand/common/common_adults.asp
    1. Alim TN, Graves E, Mellman TA, et al. Trauma exposure, posttraumatic stress disorder and depression in an African-American primary care population. J Natl Med Assoc. 2006;98(10):1630–1636. - PMC - PubMed

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