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NCT Number: NCT05685511

Behavioral Activation and Medication Optimization For Improving Perioperative Mental Health In Older Adults Undergoing Oncologic Surgery

Using a Hybrid Type 1 Effectiveness-Implementation randomized control trial (RCT) design, the investigators will test the effectiveness of a bundled behavioral activation and medication optimization in reducing symptoms of depression and anxiety in older adults undergoing oncologic surgery (compared with usual care), while examining implementation outcomes.

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Key information

Conditions

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

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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Pre-screening:

To be considered for participation, patients will be screened using PHQ-4 questionnaire. Scores >3 will indicate positive pre-screen (i.e. can be considered for participation and formal screening). Scores < 3 will indicate negative screen (i.e. patient not considered for formal screening due to low risk for anxiety or depression).

Screening:

  • Adults age ≥60 years
  • Scheduled major thoracic, breast, or abdominal surgery for suspected or confirmed malignancy
  • PHQ-ADS (Patient Health Questionnaire Anxiety and Depression Scale) ≥10 indicating clinically significant depression or anxiety symptoms.

Exclusion criteria

  • Barrier to communication (Unable to read, speak, and understand English)
  • Severe cognitive impairment screened by the SBT (Short Blessed Test) >10
  • Acutely suicidal
  • Considered ineligible per the discretion of the oncologic surgeon or study PI
  • Previous participation in this study or another CPMH study of the intervention bundle or its feasibility.

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.

Usual care resources

Other

List of resources that the patient can explore on their own

Primary outcomes

  1. PHQ-ADS

    Time frame: Baseline and 3 months post-operatively

    Change in PHQ-ADS (Patient Health Questionnaire Anxiety and Depression Scale) scores from baseline to 3 months postoperatively will be compared between the two study arms.

    PHQ-ADS is a composite measure of anxiety and depression. PHQ-ADS scores can range from 0 to 48 (with higher scores indicating more severe depression/anxiety).

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 17, 2023
Registry last updated
Mar 31, 2026

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.

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