N/A
N=29
Behavioral Activation and Medication Optimization for Perioperative Mental Health Feasibility Study
Older Adults · Anxiety · Depression · Cardiac Surgery · Orthopedic Surgery
Bottom Line
View on ClinicalTrials.gov: NCT05110690 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Reach of the Study as Measured by the Number of Participants Who Agree to Participate in the Study Out of the Total Eligible Participants — 23 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Behavioral Activation (Behavioral); Medication Optimization (Other)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reach of the Study as Measured by the Number of Participants Who Agree to Participate in the Study Out of the Total Eligible Participants |
23 | — |
| PRIMARY Reach of the Intervention Bundle as Measured by the Number of Participants Who Completed the Intervention Out of the Participants Who Agreed to Participate in the Study |
19 | — |
| SECONDARY Completeness of Planned Primary Outcome Data Collection at Specified Timepoints as Measured by the Number of Participants Who Completed 100% of the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) |
23; 15; 20 | — |
Summary
Inadequate management of preoperative mental health disorders often contributes to poor postoperative outcomes, including increased rates of readmission, delirium, falls, and mortality. However, very little work has been done to improve perioperative mental health. In particular, there have been limited systematic efforts that identify evidence-based behavioral and pharmacological strategies that were originally developed for depression and anxiety in otherwise medically well psychiatric patients. A mental health intervention bundle, composed of behavioral and pharmacological strategies, can mitigate anxiety and depression symptoms during the perioperative period. However, lacking is conclusive evidence on effectiveness of such an intervention bundle focused on the delivery of perioperative mental health care in older surgical patients. Towards this end, the investigators will develop and test an intervention bundle that encompasses: (1) behavioral activation, and (2) medication optimization.
Eligibility Criteria
Inclusion Criteria Patient Participants
- Age ≥60 years on the day of surgery;
- Scheduled major orthopedic surgery, or major surgical resection of a thoracic or abdominal malignancy, or major cardiac procedure;
- Clinically significant depression or anxiety symptoms screened by the PHQ-ADS (Patient Health Questionnaire Anxiety and Depression Scale) ≥10
Exclusion Criteria Patient Participants
- Estimated life expectancy 10;
- Acutely suicidal
Data sourced from ClinicalTrials.gov (NCT05110690). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.