Trial Title:
Behavioral Activation and Medication Optimization For Improving Perioperative Mental Health In Older Adults Undergoing Oncologic Surgery
NCT ID:
NCT05685511
Condition:
Older Adults
Anxiety
Depression
Major Surgical Resection of a Thoracic Malignancy
Major Surgical Resection of an Abdominal Malignancy
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
behavioral activation
medication optimization
thoracic surgery
oncologic surgery
perioperative mental health
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Masking description:
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.
Intervention:
Intervention type:
Behavioral
Intervention name:
Behavioral Activation
Description:
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
Arm group label:
Intervention Bundle (Behavioral Activation + Medication Optimization)
Intervention type:
Other
Intervention name:
Medication Optimization
Description:
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.
Arm group label:
Intervention Bundle (Behavioral Activation + Medication Optimization)
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
60 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Washington University School of Medicine
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Contact:
Last name:
Benjamin D Kozower, M.D., MPH
Phone:
314-362-8089
Email:
kozower@wustl.edu
Investigator:
Last name:
Benjamin D Kozower, M.D., MPH
Email:
Principal Investigator
Investigator:
Last name:
Simon Haroutounian, Ph.D., MSc
Email:
Principal Investigator
Investigator:
Last name:
Kenneth Freedland, Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Michael Avidan, MBBCh
Email:
Sub-Investigator
Investigator:
Last name:
Eric Lenze, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Joanna Abraham, Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Katherine Holzer, Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Thomas Kannampallil, Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
J. Philip Miller, Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Mary Politi, Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Ana Baumann, Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Bethany Pennington, PharmD
Email:
Sub-Investigator
Investigator:
Last name:
Katherine Clifton, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Theresa Cordner
Email:
Sub-Investigator
Start date:
March 10, 2023
Completion date:
May 31, 2025
Lead sponsor:
Agency:
Washington University School of Medicine
Agency class:
Other
Collaborator:
Agency:
National Institute of Mental Health (NIMH)
Agency class:
NIH
Source:
Washington University School of Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05685511
http://www.siteman.wustl.edu
