NCT05685511

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 17, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

March 10, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2024

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

March 31, 2026

Completed
Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

1.3 years

First QC Date

January 5, 2023

Results QC Date

March 11, 2026

Last Update Submit

March 11, 2026

Conditions

Older AdultsAnxietyDepressionMajor Surgical Resection of a Thoracic MalignancyMajor Surgical Resection of an Abdominal Malignancy

Keywords

behavioral activationmedication optimizationthoracic surgeryoncologic surgeryperioperative mental health

Outcome Measures

Primary Outcomes (1)

  • PHQ-ADS

    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).

    Baseline and 3 months post-operatively

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

Patients will receive resources either by mail or email. The resources include options for exploring brain health, supporting sleep and mental health, and introducing community resources for older adults.

Other: Usual care resources

Intervention Bundle (Behavioral Activation + Medication Optimization)

EXPERIMENTAL

* Behavioral activation (BA) will span across 3 months postoperatively \& will begin pre-operatively, with sessions approximately every two weeks. After discharge, the behavioral intervention will continue for 10-12 sessions, or out to approximately 3 months postoperatively. * 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 ActivationOther: Medication Optimization

Interventions

Behavioral ActivationBEHAVIORAL

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 Bundle (Behavioral Activation + Medication Optimization)
Medication OptimizationOTHER

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 Bundle (Behavioral Activation + Medication Optimization)
Usual care resourcesOTHER

List of resources that the patient can explore on their own

Usual Care

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

  • Holzer KJ, Bartosiak KA, Calfee RP, Hammill CW, Haroutounian S, Kozower BD, Cordner TA, Lenard EM, Freedland KE, Tellor Pennington BR, Wolfe RC, Miller JP, Politi MC, Zhang Y, Yingling MD, Baumann AA, Kannampallil T, Schweiger JA, McKinnon SL, Avidan MS, Lenze EJ, Abraham J. Perioperative mental health intervention for depression and anxiety symptoms in older adults study protocol: design and methods for three linked randomised controlled trials. BMJ Open. 2024 Apr 3;14(4):e082656. doi: 10.1136/bmjopen-2023-082656.

    PMID: 38569683DERIVED

Related Links

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Results Point of Contact

Title
Benjamin D. Kozower, M.D, MPH
Organization
Washington University School of Medicine
kozower@wustl.edu
314-362-8089

Study Officials

  • Benjamin D Kozower, M.D., MPH

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Study staff responsible for administering ratings throughout the study are blinded. This blinding is kept throughout the study until data collection is complete. At the end of the follow-up, the study coordinator will complete a blinding question to try to guess the arm to which each participant was allocated. This will allow to determine whether the blinding procedures in the study were effective.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2023

First Posted

January 17, 2023

Study Start

March 10, 2023

Primary Completion

July 12, 2024

Study Completion

July 12, 2024

Last Updated

March 31, 2026

Results First Posted

March 31, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)