Behavioral Activation and Medication Optimization for Perioperative Mental Health Feasibility Study

NCT ID: NCT05110690

Last Updated: 2023-12-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-17
• Study Completion Date: 2022-12-22

Brief 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.

Detailed 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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patient Participants

• 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.

Group Type: EXPERIMENTAL

Behavioral Activation

Intervention Type: BEHAVIORAL

The behavioral intervention will consist of behavioral activation (BA), the basic premise of which is to help people with mental health problems to engage in activities that are reinforcing or meaningful and guided by their personal values

Medication Optimization

Intervention Type: OTHER

Medication optimization consists of a simple set of principles: reconcile patient's medications, identify the patient's likely need for, and interest in, a medication adjustment, make the adjustment, and assess the response to that adjustment.

Interventions

Behavioral Activation

The behavioral intervention will consist of behavioral activation (BA), the basic premise of which is to help people with mental health problems to engage in activities that are reinforcing or meaningful and guided by their personal values

Intervention Type: BEHAVIORAL

Medication Optimization

Medication optimization consists of a simple set of principles: reconcile patient's medications, identify the patient's likely need for, and interest in, a medication adjustment, make the adjustment, and assess the response to that adjustment.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Avidan, MBBCh, FCASA

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

References

Abraham J, Meng A, Baumann A, Holzer KJ, Lenard E, Freedland KE, Lenze EJ, Avidan MS, Politi MC. A multi- and mixed-method adaptation study of a patient-centered perioperative mental health intervention bundle. BMC Health Serv Res. 2023 Oct 27;23(1):1175. doi: 10.1186/s12913-023-10186-3.

Reference Type: DERIVED

PMID: 37891574 (View on PubMed)

Abraham J, Holzer KJ, Lenard EM, Freedland KE, Tellor Pennington BR, Wolfe RC, Cordner TA, Baumann AA, Politi M, Avidan MS, Lenze E. Perioperative mental health intervention bundle for older surgical patients: protocol for an intervention development and feasibility study. BMJ Open. 2022 Aug 23;12(8):e062398. doi: 10.1136/bmjopen-2022-062398.

Reference Type: DERIVED

PMID: 35998971 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

http://www.siteman.wustl.edu

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Other Identifiers

1P50MH122351

Identifier Type: NIH

Identifier Source: secondary_id

View Link

202101103

Identifier Type: -

Identifier Source: org_study_id