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. 2024 Apr 3;14(4):e082656.
doi: 10.1136/bmjopen-2023-082656.

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

Katherine J Holzer #  1 , Kimberly A Bartosiak #  2 , Ryan P Calfee  2 , Chet W Hammill  3 , Simon Haroutounian  4 , Benjamin D Kozower  3 , Theresa A Cordner  4 , Emily M Lenard  5 , Kenneth E Freedland  5 , Bethany R Tellor Pennington  4 , Rachel C Wolfe  6 , J Philip Miller  7 , Mary C Politi  3 , Yi Zhang  5 , Michael D Yingling  5 , Ana A Baumann  3 , Thomas Kannampallil  4   7 , Julia A Schweiger  5 , Sherry L McKinnon  4 , Michael S Avidan  4 , Eric J Lenze  5 , Joanna Abraham  4   7
Affiliations

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

Katherine J Holzer et al. BMJ Open. .

Abstract

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.

Keywords: Aged; Clinical Trial; Implementation Science; MENTAL HEALTH; SURGERY.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Study flow diagram for each surgical cohort. *Note: 2-month timepoint for intervention group is the target engagement assessment. PHQ-4, Patient Health Questionnaire-4; PHQ-ADS, Patient Health Questionnaire-Anxiety Depression Scale.
Figure 2
Figure 2
Timeline of the intervention delivery. BA, behavioural activation; MO, medication optimisation.
Figure 3
Figure 3
Revised power calculation for 46 participants in each group for a 2-sided t-test at alpha=0.05 and within group SD of 8.8.
See this image and copyright information in PMC

References

    1. Mangusan RF, Hooper V, Denslow SA, et al. . Outcomes associated with postoperative delirium after cardiac surgery. Am J Crit Care 2015;24:156–63. 10.4037/ajcc2015137 - DOI - PubMed
    1. Carney RM, Blumenthal JA, Catellier D, et al. . Depression as a risk factor for mortality after acute myocardial infarction. Am J Cardiol 2003;92:1277–81. 10.1016/j.amjcard.2003.08.007 - DOI - PubMed
    1. Connerney I, Shapiro PA, McLaughlin JS, et al. . Relation between depression after coronary artery bypass surgery and 12-month outcome: a prospective study. Lancet 2001;358:1766–71. 10.1016/S0140-6736(01)06803-9 - DOI - PubMed
    1. McKenzie LH, Simpson J, Stewart M. A systematic review of pre-operative predictors of post-operative depression and anxiety in individuals who have undergone coronary artery bypass graft surgery. Psychol Health Med 2010;15:74–93. 10.1080/13548500903483486 - DOI - PubMed
    1. Takagi H, Ando T, Umemoto T, et al. . Perioperative depression or anxiety and postoperative mortality in cardiac surgery: a systematic review and meta-analysis. Heart Vessels 2017;32:1458–68. 10.1007/s00380-017-1022-3 - DOI - PubMed

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