Behavioral Activation and Medication Optimization for Perioperative Mental Health Feasibility Study

The Washington University

Status: Completed

Conditions: Major Surgical Resection of a Thoracic Malignancy; Cardiac Surgery; Orthopedic Surgery; Major Surgical Resection of an Abdominal Malignancy; Older Adults; Depression; Anxiety

Treatments: Other: Medication Optimization; Behavioral: Behavioral Activation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05110690

1P50MH122351 (U.S. NIH Grant/Contract)

202101103

Details and patient eligibility

About

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.

Full description

The proposed research is relevant to public health because the prevalence of undertreated depression/anxiety in older adults coupled with the increasing number of surgeries performed in this population are creating a crucial need for the integration of mental health interventions into critical periods, such as the perioperative period. Thus, the proposed research is relevant to the mission of the NIMH to transform the treatment of mental illnesses through clinical research, paving the way for prevention, recovery, and cure.

Enrollment: 24 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 < 12 months;
• Unable to read, speak, and understand English;
• Current alcohol or other substance abuse;
• Severe cognitive impairment screened by the SBT (Short Blessed Test) >10;
• Acutely suicidal

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Patient Participants

Experimental group

Description:

* Behavioral activation (BA) will span across 3 months postoperatively \& will begin pre-operatively, with sessions approximately weekly or biweekly, depending on patient preference \& health condition. * Medications will be reviewed \& optimized by a team of interventionists including a psychiatrist, pharmacologist, \& pharmacists. While the participant is in-hospital, the interventionist's role will include coordinating with the hospital team to ensure that medication changes that were introduced preoperatively are maintained in-house \& that no new inappropriate medications are initiated. After discharge, \& up to approximately 3 months postoperatively, the interventionist will ensure that medication changes are reconciled during transitions of care. The interventionists will ensure the agreed-upon changes are implemented, or an alternative course of action is justified.

Treatment:

Other: Medication Optimization

Behavioral: Behavioral Activation