Behavioral Activation and Medication Optimization for Perioperative Mental Health Feasibility Study

NCT05110690 | Completed Results

• 2 other identifiers: 2021011031P50MH122351
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Reach of the Study as Measured by the Number of Participants Who Agree to Participate in the Study Out of the Total Eligible Participants

  Through completion of the study (13 months and 5 days)

• 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

  Through completion of the study (13 months and 5 days)

Secondary Outcomes (1)

• 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)

  Baseline, 1 month, and 3 months

Study Arms (1)

Patient Participants

EXPERIMENTAL

* 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.

Behavioral: Behavioral Activation; Other: Medication Optimization

Interventions

Behavioral Activation 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

Patient Participants

Medication Optimization 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.

Patient Participants

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (2)

• 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.

  PMID: 37891574 DERIVED

• 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.

  PMID: 35998971 DERIVED

Related Links

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

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Michael Avidan, MBBCh, FCASA
• Organization: Washington University School of Medicine

avidanm@wustl.edu

314-273-4136

Study Officials

• Michael Avidan, MBBCh, FCASA

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: November 8, 2021
• Study Start: November 17, 2021
• Primary Completion: December 22, 2022
• Study Completion: December 22, 2022
• Last Updated: December 18, 2023
• Results First Posted: December 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)