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.
Effectiveness
Hybrid
Implementation
Posttraumatic stress disorder
Stepped care
Journal
Contemporary clinical trials
ISSN: 1559-2030
Titre abrégé: Contemp Clin Trials
Pays: United States
ID NLM: 101242342
Informations de publication
Date de publication:
08 2023
08 2023
Historique:
received:
17
02
2023
revised:
06
04
2023
accepted:
22
05
2023
pmc-release:
01
08
2024
medline:
24
7
2023
pubmed:
28
5
2023
entrez:
27
5
2023
Statut:
ppublish
Résumé
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. 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. 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. NCT04937504.
Sections du résumé
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.
Identifiants
pubmed: 37244367
pii: S1551-7144(23)00164-7
doi: 10.1016/j.cct.2023.107241
pmc: PMC10527289
mid: NIHMS1906346
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT04937504']
Types de publication
Journal Article
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
107241Subventions
Organisme : NIMH NIH HHS
ID : F31 MH011722
Pays : United States
Organisme : NIMH NIH HHS
ID : K23 MH117221
Pays : United States
Informations de copyright
Copyright © 2023 Elsevier Inc. All rights reserved.
Déclaration de conflit d'intérêts
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.
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