Perioperative mental health intervention for depression and anxiety symptoms in older adults study protocol: design and methods for three linked randomised controlled trials.

Autor: Holzer KJ; Department of Anesthesiology, Washington University School of Medicine in Saint Louis, St Louis, Missouri, USA kholzer@wustl.edu., Bartosiak KA; Department of Orthopaedics, Washington University School of Medicine in Saint Louis, St Louis, Missouri, USA., Calfee RP; Department of Orthopaedics, Washington University School of Medicine in Saint Louis, St Louis, Missouri, USA., Hammill CW; Department of Surgery, Washington University School of Medicine in Saint Louis, St Louis, Missouri, USA., Haroutounian S; Department of Anesthesiology, Washington University School of Medicine in Saint Louis, St Louis, Missouri, USA., Kozower BD; Department of Surgery, Washington University School of Medicine in Saint Louis, St Louis, Missouri, USA., Cordner TA; Department of Anesthesiology, Washington University School of Medicine in Saint Louis, St Louis, Missouri, USA., Lenard EM; Department of Psychiatry, Washington University School of Medicine in Saint Louis, St Louis, Missouri, USA., Freedland KE; Department of Psychiatry, Washington University School of Medicine in Saint Louis, St Louis, Missouri, USA., Tellor Pennington BR; Department of Anesthesiology, Washington University School of Medicine in Saint Louis, St Louis, Missouri, USA., Wolfe RC; Department of Pharmacy, Barnes-Jewish Hospital, St Louis, Missouri, USA., Miller JP; Institute for Informatics, Data Science and Biostatistics, Washington University School of Medicine in Saint Louis, St. Louis, Missouri, USA., Politi MC; Department of Surgery, Washington University School of Medicine in Saint Louis, St Louis, Missouri, USA., Zhang Y; Department of Psychiatry, Washington University School of Medicine in Saint Louis, St Louis, Missouri, USA., Yingling MD; Department of Psychiatry, Washington University School of Medicine in Saint Louis, St Louis, Missouri, USA., Baumann AA; Department of Surgery, Washington University School of Medicine in Saint Louis, St Louis, Missouri, USA., Kannampallil T; Department of Anesthesiology, Washington University School of Medicine in Saint Louis, St Louis, Missouri, USA.; Institute for Informatics, Data Science and Biostatistics, Washington University School of Medicine in Saint Louis, St. Louis, Missouri, USA., Schweiger JA; Department of Psychiatry, Washington University School of Medicine in Saint Louis, St Louis, Missouri, USA., McKinnon SL; Department of Anesthesiology, Washington University School of Medicine in Saint Louis, St Louis, Missouri, USA., Avidan MS; Department of Anesthesiology, Washington University School of Medicine in Saint Louis, St Louis, Missouri, USA., Lenze EJ; Department of Psychiatry, Washington University School of Medicine in Saint Louis, St Louis, Missouri, USA., Abraham J; Department of Anesthesiology, Washington University School of Medicine in Saint Louis, St Louis, Missouri, USA.; Institute for Informatics, Data Science and Biostatistics, Washington University School of Medicine in Saint Louis, St. Louis, Missouri, USA.
Jazyk: angličtina
Zdroj: BMJ open [BMJ Open] 2024 Apr 03; Vol. 14 (4), pp. e082656. Date of Electronic Publication: 2024 Apr 03.
DOI: 10.1136/bmjopen-2023-082656
Abstrakt: Introduction: Preoperative anxiety and depression symptoms among older surgical patients are associated with poor postoperative outcomes, yet evidence-based interventions for anxiety and depression have not been applied within this setting. We present a protocol for randomised controlled trials (RCTs) in three surgical cohorts: cardiac, oncological and orthopaedic, investigating whether a perioperative mental health intervention, with psychological and pharmacological components, reduces perioperative symptoms of depression and anxiety in older surgical patients.
Methods and Analysis: Adults ≥60 years undergoing cardiac, orthopaedic or oncological surgery will be enrolled in one of three-linked type 1 hybrid effectiveness/implementation RCTs that will be conducted in tandem with similar methods. In each trial, 100 participants will be randomised to a remotely delivered perioperative behavioural treatment incorporating principles of behavioural activation, compassion and care coordination, and medication optimisation, or enhanced usual care with mental health-related resources for this population. The primary outcome is change in depression and anxiety symptoms assessed with the Patient Health Questionnaire-Anxiety Depression Scale from baseline to 3 months post surgery. Other outcomes include quality of life, delirium, length of stay, falls, rehospitalisation, pain and implementation outcomes, including study and intervention reach, acceptability, feasibility and appropriateness, and patient experience with the intervention.
Ethics and Dissemination: The trials have received ethics approval from the Washington University School of Medicine Institutional Review Board. Informed consent is required for participation in the trials. The results will be submitted for publication in peer-reviewed journals, presented at clinical research conferences and disseminated via the Center for Perioperative Mental Health website.
Trial Registration Numbers: NCT05575128, NCT05685511, NCT05697835, pre-results.
Competing Interests: Competing interests: None declared.
(© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze: MEDLINE