Skip to main content
OpenTrials
Completed

NCT Number: NCT05110690

Behavioral Activation and Medication Optimization for Perioperative Mental Health Feasibility Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Older Adults Anxiety Anxiety Disorders Behavior Behavioral Symptoms Cardiac Surgery Depression Major Surgical Resection of a Thoracic Malignancy Major Surgical Resection of an Abdominal Malignancy Mental Disorders Orthopedic Surgery

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

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

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

  2. 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

    Time frame: 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)

    Time frame: Baseline, 1 month, and 3 months

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 8, 2021
Registry last updated
Dec 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.