Perioperative mental health intervention for depression and anxiety symptoms in older adults study protocol: design and methods for three linked randomised controlled trials
Thomas Kannampallil,
Joanna Abraham,
Katherine J Holzer,
Yi Zhang,
Michael S Avidan,
Sherry L McKinnon,
Simon Haroutounian,
J Philip Miller,
Ana A Baumann,
Emily M Lenard,
Kenneth E Freedland,
Bethany R Tellor Pennington,
Rachel C Wolfe,
Theresa A Cordner,
Chet W Hammill,
Mary C Politi,
Kimberly A Bartosiak,
Ryan P Calfee,
Benjamin D Kozower,
Michael D Yingling,
Julia A Schweiger,
Eric J Lenze
Affiliations
Thomas Kannampallil
Institute for Informatics, Data Science and Biostatistics, Washington University School of Medicine in Saint Louis, St. Louis, Missouri, USA
Joanna Abraham
Department of Anesthesiology, Washington University School of Medicine in Saint Louis, St Louis, Missouri, USA
Katherine J Holzer
Department of Anesthesiology, Washington University School of Medicine in Saint Louis, St Louis, Missouri, USA
Yi Zhang
Department of Psychiatry, Washington University School of Medicine in Saint Louis, St Louis, Missouri, USA
Michael S Avidan
Department of Anesthesiology, Washington University School of Medicine in Saint Louis, St Louis, Missouri, USA
Sherry L McKinnon
Department of Anesthesiology, Washington University School of Medicine in Saint Louis, St Louis, Missouri, USA
Simon Haroutounian
Department of Anesthesiology, Washington University School of Medicine in Saint Louis, St Louis, Missouri, USA
J Philip Miller
Institute for Informatics, Data Science and Biostatistics, Washington University School of Medicine in Saint Louis, St. Louis, Missouri, USA
Ana A Baumann
Department of Surgery, Washington University School of Medicine in Saint Louis, St Louis, Missouri, USA
Emily M Lenard
Department of Psychiatry, Washington University School of Medicine in Saint Louis, St Louis, Missouri, USA
Kenneth E Freedland
Department of Psychiatry, Washington University School of Medicine in Saint Louis, St Louis, Missouri, USA
Bethany R Tellor Pennington
Department of Anesthesiology, Washington University School of Medicine in Saint Louis, St Louis, Missouri, USA
Rachel C Wolfe
Department of Pharmacy, Barnes-Jewish Hospital, St Louis, Missouri, USA
Theresa A Cordner
Department of Anesthesiology, Washington University School of Medicine in Saint Louis, St Louis, Missouri, USA
Chet W Hammill
Department of Surgery, Washington University School of Medicine in Saint Louis, St Louis, Missouri, USA
Mary C Politi
Department of Surgery, Washington University School of Medicine in Saint Louis, St Louis, Missouri, USA
Kimberly A Bartosiak
Department of Orthopaedics, Washington University School of Medicine in Saint Louis, St Louis, Missouri, USA
Ryan P Calfee
Department of Orthopaedics, Washington University School of Medicine in Saint Louis, St Louis, Missouri, USA
Benjamin D Kozower
Department of Surgery, Washington University School of Medicine in Saint Louis, St Louis, Missouri, USA
Michael D Yingling
Department of Psychiatry, Washington University School of Medicine in Saint Louis, St Louis, Missouri, USA
Julia A Schweiger
Department of Psychiatry, Washington University School of Medicine in Saint Louis, St Louis, Missouri, USA
Eric J Lenze
Department of Psychiatry, Washington University School of Medicine in Saint Louis, St Louis, Missouri, USA
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.